<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03239522</url>
  </required_header>
  <id_info>
    <org_study_id>200232</org_study_id>
    <secondary_id>2017-001729-42</secondary_id>
    <nct_id>NCT03239522</nct_id>
  </id_info>
  <brief_title>Absorption and Elimination of Radiolabeled Daprodustat</brief_title>
  <official_title>An Open-label Study in Healthy Male Participants to Determine the Mass Balance, Absolute Bioavailability and Pharmacokinetics of Daprodustat, Administered as a Single Intravenous Microtracer (Concomitant With an Oral Dose of Non-radiolabelled Daprodustat) and a Single, Oral Radiolabelled Dose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in&#xD;
      previous clinical trials; however, the elimination routes and metabolic pathways of&#xD;
      daprodustat have not been fully elucidated in humans. This is an open-label, single-center,&#xD;
      non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male&#xD;
      participants. The aim of the study is to assess the excretion balance of daprodustat using&#xD;
      [14C]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion,&#xD;
      administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose).&#xD;
      Absolute bioavailability of an oral dose will also be assessed. Each participant will be&#xD;
      involved in the study for up to 10 weeks which include a screening visit, two treatment&#xD;
      periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral&#xD;
      doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The&#xD;
      primary objective of the study is to gain a better understanding of the compound's excretory&#xD;
      and metabolic profile. This study will include sampling of duodenal bile to conduct&#xD;
      qualitative assessment of drug metabolites in this matrix in order to characterize biliary&#xD;
      elimination pathways.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">November 28, 2017</completion_date>
  <primary_completion_date type="Actual">November 28, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-Inf]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable [NQ] values were considered as non-missing values).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC (0-Inf) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf). The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC (0-t) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2. The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution at Steady State (Vss) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Plasma samples were collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vss of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Blood samples were planned to be collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Systemic Clearance (CL) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Plasma samples were collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Blood samples were planned to be collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of the Total Radioactive Dose Excreted in Urine Over Time Following a Single, Oral Dose of [14C]-GSK1278863</measure>
    <time_frame>Pre-dose and then over 24 hours collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120,120-144 and 144-168 hours post-dose in treatment period 2</time_frame>
    <description>Urine samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in urine. All participants were asked to void their bladders before study treatment administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of the Total Radioactive Dose Excreted in Feces Over Time Following a Single, Oral Dose of [14C]-GSK1278863</measure>
    <time_frame>Pre-dose and then over 24 hour collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2</time_frame>
    <description>Fecal samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in feces.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of the Total Radioactive Dose Excreted in Urine and Feces Determined as Total Excretion Over Time</measure>
    <time_frame>Pre-dose and then over 24 hour collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2</time_frame>
    <description>Urine and fecal samples were collected at the indicated time points to determine the rate and extent of cumulative excretion of total radioactivity in urine and feces.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC (0-Inf) of GSK1278863 in Plasma Following Administration IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-t) of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC (0-Inf) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863.Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC(0-t) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vss of GSK1278863 in Plasma Following IV Dose Administration</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vss of GSK1278863 Metabolites in Plasma Following IV Dose Administration</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL of GSK1278863 in Plasma Following IV Dose Administration</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL of GSK1278863 Metabolites in Plasma Following IV Dose Administration</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Bioavailability of GSK1278863 Following Oral Dosing</measure>
    <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
    <description>Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as ratio of AUC(oral)/Dose(oral) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses administered in treatment period 1 was analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Radioactivity Recovered for Each Metabolite in Plasma Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</measure>
    <time_frame>0-8 hours, 10-12 hours in period 2</time_frame>
    <description>Blood samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. 2 pooled plasma samples were prepared. Aliquots of plasma samples collected between 0 to 8 hours post-dose from each participant were pooled in proportion to the time intervals. An equal amount of the individual pools from each participant was then pooled to create 1 plasma sample that was representative of the mean area under curve over the range of 0-8 hour. The second pool (10-12 hours pool) was obtained by mixing equal volume of the plasma samples at 10 and 12 hour across all participants. Percent radioactivity recovered for each metabolite in plasma following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Radioactivity Recovered for Each Metabolite in Urine Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</measure>
    <time_frame>0-24 hours in period 2</time_frame>
    <description>Urine samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled urine sample was prepared by urine collected from 0 to 24 hours post dose from all participants. Percent radioactivity recovered for each metabolite in urine following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Radioactivity Recovered for Each Metabolite in Feces Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</measure>
    <time_frame>0-120 hours in period 2</time_frame>
    <description>Feces samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled feces sample was prepared by samples collected from 0 to 120 hours post dose from all participants. Percent radioactivity recovered for each metabolite in feces following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Radioactivity Recovered for Each Metabolite in Duodenal Bile Following a Single Dose of [14C]-GSK1278863 50 µg IV Infusion</measure>
    <time_frame>3 hours post-oral dose in period 1</time_frame>
    <description>The bile string was swallowed by participants prior to oral dose and was removed 3 hours after the oral dose (1 hour after the end of the IV infusion) in treatment period-1. Duodenal bile string extracts were pooled to create a single pool sample to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single dose of [14C]-GSK1278863 50 µg IV infusion. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102). Mean percent radioactivity recovered for each metabolite in bile following a single dose of [14C]-GSK1278863 50 µg IV infusion is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)</measure>
    <time_frame>Up to 43 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per Medical or scientific judgment. Safety Population comprised of all participants who take at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AEs at a Particular Severity</measure>
    <time_frame>Up to 43 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity was categorized as mild, moderate and severe. The number of participants with AEs at any type of severity (mild, moderate and severe) has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range</measure>
    <time_frame>Up to 43 days</time_frame>
    <description>Blood samples were collected from participants at indicated time points for the analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Protein, Sodium and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (example given [e.g.], High to High), or whose value became normal, are recorded in the &quot;To Normal or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst Case Hematology Results Relative to Normal Range</measure>
    <time_frame>Up to 43 days</time_frame>
    <description>Blood samples were collected from participants at indicated time points for the analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes, and Reticulocytes/Erythrocytes. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the &quot;To Normal or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Urinalysis Findings</measure>
    <time_frame>Up to 43 days</time_frame>
    <description>Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity and PH of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Electrocardiogram (ECG) Findings</measure>
    <time_frame>Pre-dose (on Day 1) and Day 8 in treatment period 2; 144 hours (Day 7) in treatment period 1</time_frame>
    <description>Full 12-lead ECGs were recorded with the participant in a supine position. The number of participants with abnormal ECG findings at indicated time points were presented. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Pressure</measure>
    <time_frame>Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
    <description>Vital sign including systolic and diastolic blood pressure were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Average [Avg] Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heart Rate</measure>
    <time_frame>Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
    <description>Heart rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Avg Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Rate</measure>
    <time_frame>Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
    <description>Respiratory rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Body Temperature</measure>
    <time_frame>Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
    <description>Body temperature measurement was performed in participants at indicated time points. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Anaemia</condition>
  <arm_group>
    <arm_group_label>All participants receiving treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will receive a single 6 milligram (mg) oral dose of daprodustat on Day 1 of period 1. After approximately 1 hour, participants will receive 50 microgram (µg) of [14C]-GSK1278863 by IV infusion over 1 hour. On Day 1 of period 2, each participant will receive 25 mg [14C]-GSK1278863 as an oral solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-GSK1278863 solution for IV infusion</intervention_name>
    <description>It is a clear, colorless solution free from visible particulate matter. Participants will receive 10 mL of 5 µg/mL of [14C]-GSK1278863 IV solution (total dose: 50 µg) by IV infusion over 1 hour.</description>
    <arm_group_label>All participants receiving treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-GSK1278863 oral solution</intervention_name>
    <description>It is a clear, colorless solution. Participants will receive 125 mL of 200 µg/mL of [14C]-GSK1278863 oral solution (total dose: 25 mg).</description>
    <arm_group_label>All participants receiving treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daprodustat 6 mg oral tablet</intervention_name>
    <description>It is a 9.0 millimeter (mm) round, white film coated tablet.</description>
    <arm_group_label>All participants receiving treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 30 to 55 years, inclusive, at the time of signing the informed consent.&#xD;
&#xD;
          -  Healthy, as determined by the investigator or medically qualified designee, based on a&#xD;
             medical evaluation including medical history, physical examination, vital signs,&#xD;
             laboratory tests, and ECG. A participant with a clinical abnormality or laboratory&#xD;
             parameter (i.e., outside the reference range for the population being studied), which&#xD;
             is not specifically listed in the eligibility criteria, may be included only if the&#xD;
             investigator agrees and documents that the finding is unlikely to introduce additional&#xD;
             risk factors and will not interfere with the study procedures.&#xD;
&#xD;
          -  Hemoglobin value at screening greater than the lower limit of the laboratory reference&#xD;
             range and less than or equal to 16.0 gram (g) per deciliter (dL).&#xD;
&#xD;
          -  History of regular bowel movements (averaging one or more bowel movements per day).&#xD;
&#xD;
          -  Non-smoker, or ex-smoker who hasn't regularly smoked for the 6 months before&#xD;
             screening.&#xD;
&#xD;
          -  Body weight of 50 kilogram (kg) and above, and body mass index (BMI) within the range&#xD;
             19.0-31 kg per meter (m)^2 (inclusive).&#xD;
&#xD;
          -  Participants must agree to use contraception as follows: participants with female&#xD;
             partners of childbearing potential must agree to use a condom from the time of first&#xD;
             dose of study treatment until 1 month after their last dose.&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#xD;
&#xD;
          -  Willingness to give written consent to have data entered into The Over-volunteering&#xD;
             Prevention System.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome or asymptomatic gallstones). Participants&#xD;
             with a history of cholecystectomy must be excluded.&#xD;
&#xD;
          -  Any clinically relevant abnormality identified at the screening medical assessment&#xD;
             (physical examination/medical history), clinical laboratory tests, or 12-lead ECG.&#xD;
&#xD;
          -  Myocardial infarction or acute coronary syndrome &lt;=12 weeks prior to screening through&#xD;
             to enrollment (Day 1, treatment period 1).&#xD;
&#xD;
          -  History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal&#xD;
             (GI), endocrine, hematological, or neurological disorders capable of significantly&#xD;
             altering the absorption, metabolism, or elimination of drugs, or which could&#xD;
             constitute a risk when taking the study treatment, or interfere with the&#xD;
             interpretation of data.&#xD;
&#xD;
          -  Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR&#xD;
             clinically significant GI bleeding &lt;=12 weeks prior to screening through to enrollment&#xD;
             (Day 1, treatment period 1).&#xD;
&#xD;
          -  History of malignancy within the two years before dosing, with the exception of&#xD;
             localized squamous cell or basal cell carcinoma of the skin that has been definitively&#xD;
             treated prior to screening; currently receiving treatment for cancer; has a strong&#xD;
             family history of cancer (e.g., familial cancer disorders).&#xD;
&#xD;
          -  Mentally or legally incapacitated.&#xD;
&#xD;
          -  Heart Failure: Class II, III or IV heart failure, as defined by the New York Heart&#xD;
             Association (NYHA) functional classification system.&#xD;
&#xD;
          -  Any other condition, clinical or laboratory abnormality, or examination finding that&#xD;
             the investigator considers would put the participant at unacceptable risk, which may&#xD;
             affect study compliance or prevent understanding of the aims or investigational&#xD;
             procedures or possible consequences of the study.&#xD;
&#xD;
          -  Daprodustat is a substrate of cytochrome P4502C8 (CYP2C8). Co-administration of drugs&#xD;
             that are inhibitors of this enzyme are prohibited.&#xD;
&#xD;
          -  Past or intended use of over-the-counter or prescription medication including herbal&#xD;
             medications prior to dosing except occasional use of paracetamol (acetaminophen),&#xD;
             within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives&#xD;
             (whichever is longer) prior to the first dose of study treatment until completion of&#xD;
             the follow-up visit, unless in the opinion of the investigator and GSK medical monitor&#xD;
             the medication will not interfere with the study.&#xD;
&#xD;
          -  Current enrolment in a clinical trial; recent participation in a clinical trial and&#xD;
             has received an investigational product within 3 months before their first dose in the&#xD;
             current study.&#xD;
&#xD;
          -  Exposure to more than 4 new chemical entities within 12 months before their first dose&#xD;
             in the current study.&#xD;
&#xD;
          -  Participation in a clinical trial involving administration of 14C-labelled compound(s)&#xD;
             within the last 12 months. A participant's previous effective dose will be reviewed by&#xD;
             the medical investigator to ensure there is no risk of contamination/carryover into&#xD;
             the current study.&#xD;
&#xD;
          -  Received a total body radiation dose of greater than 10.0 millisievert (mSv) (upper&#xD;
             limit of world health organization [WHO] category II) or exposure to significant&#xD;
             radiation (e.g., serial x-ray or computed tomography [CT] scans, barium meal, etc.) in&#xD;
             the 3 years before this study.&#xD;
&#xD;
          -  Alanine transaminase (ALT) &gt;1.5 times upper limit of normal (ULN).&#xD;
&#xD;
          -  Bilirubin &gt;1.5 times ULN (isolated bilirubin &gt;1.5 times ULN is acceptable if bilirubin&#xD;
             is fractionated and direct bilirubin &lt;35%).&#xD;
&#xD;
          -  QTc &gt;500 millisecond (msec). The QTc must be the QTcB.&#xD;
&#xD;
          -  Presence of Hepatitis B surface antigen (HBsAg) at screening or positive Hepatitis C&#xD;
             antibody test result at screening or within 3 months before the first dose of study&#xD;
             treatment.&#xD;
&#xD;
          -  Positive pre-study drug/alcohol screen.&#xD;
&#xD;
          -  Positive human immunodeficiency virus (HIV) antibody test.&#xD;
&#xD;
          -  Regular use of known drugs of abuse.&#xD;
&#xD;
          -  Regular alcohol consumption within 6 months prior to the study defined as an average&#xD;
             weekly intake of &gt;21 units. One unit is equivalent to 8 g of alcohol: a glass&#xD;
             (approximately 240 milliliter [mL]) of beer, 1 small glass (approximately 100 mL) of&#xD;
             wine or 1 (approximately 25 mL) measure of spirits.&#xD;
&#xD;
          -  At screening, a supine blood pressure (BP) that is persistently higher than 140/90&#xD;
             millimeters of mercury (mmHg) taken in triplicate, unless deemed not clinically&#xD;
             significant by the investigator.&#xD;
&#xD;
          -  At screening, a supine mean heart rate (HR) outside the range of 40-100 beats per&#xD;
             minute, unless deemed not clinically significant by the investigator.&#xD;
&#xD;
          -  Has had an occupation which requires monitoring for radiation exposure, nuclear&#xD;
             medicine procedures, or excessive x-rays within the past 12 months.&#xD;
&#xD;
          -  Unable to refrain from consumption of prohibited food and drinks from 7 days before&#xD;
             the first dose of study medication until the follow up visit.&#xD;
&#xD;
          -  Participation in the study would result in donation of blood or blood products in&#xD;
             excess of 550 mL within a 90 day period.&#xD;
&#xD;
          -  Unwillingness or inability to follow the procedures, including the use of the&#xD;
             Entero-Test capsule.&#xD;
&#xD;
          -  Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or&#xD;
             nicotine-containing products in the 6 months prior to screening.&#xD;
&#xD;
          -  History of drug abuse or dependence within 6 months of the study.&#xD;
&#xD;
          -  History of sensitivity to daprodustat, or their components thereof, or a history of&#xD;
             drug or other allergy that, in the opinion of the investigator or GSK medical monitor,&#xD;
             contraindicates their participation.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only male participants, aged 30 to 55 years (inclusive) will be enrolled into the study.</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>NW10 7EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <results_first_submitted>November 26, 2018</results_first_submitted>
  <results_first_submitted_qc>November 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2019</results_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GSK1278863</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>mass balance</keyword>
  <keyword>daprodustat</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03239522/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03239522/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study evaluated the excretion balance of daprodustat(GSK1278863) using radiolabeled 14 Carbon [14C]-drug substance administered orally, and as an intravenous (IV) infusion, administered as a micro tracer dose (concomitant with an oral, non-radiolabeled dose) in healthy male participants.</recruitment_details>
      <pre_assignment_details>Participants were enrolled at a single center in United Kingdom. A total of 6 participants were enrolled in the study. All the enrolled participants were randomized to receive study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Participants Receiving GSK1278863</title>
          <description>Participants received a single 6 milligram (mg) oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 microgram (µg) [14C]-GSK1278863 by IV infusion over 1 hour. It was followed by a washout period of 7 days. On Day 1 of treatment period 2, each participant received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 (Up to 7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period (Up to 7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 2 (Up to 15 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants Receiving GSK1278863</title>
          <description>Participants received a single 6 milligram (mg) oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 microgram (µg) [14C]-GSK1278863 by IV infusion over 1 hour. It was followed by a washout period of 7 days. On Day 1 of treatment period 2, each participant received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.7" spread="8.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>WHITE - ARABIC/NORTH AFRICAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-Inf]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
        <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable [NQ] values were considered as non-missing values).</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-Inf]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
          <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable [NQ] values were considered as non-missing values).</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Hour*nanogram equivalent per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6864" spread="19.8"/>
                    <measurement group_id="O2" value="2278.8914" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC (0-Inf) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
        <description>Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf). The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation). Data were not analyzed for radiolabeled oral dose GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-Inf) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
          <description>Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf). The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.</description>
          <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation). Data were not analyzed for radiolabeled oral dose GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
        <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
          <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population</population>
          <units>Hour*nanogram equivalent per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5252" spread="18.9"/>
                    <measurement group_id="O2" value="2206.7099" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC (0-t) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
        <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-t) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
          <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
          <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
          <units>Hour*nanogram equivalent per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="824.6102" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
        <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
          <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population</population>
          <units>Nanogram equivalent per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0114" spread="15.8"/>
                    <measurement group_id="O2" value="623.9059" spread="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
        <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
          <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
          <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
          <units>Nanogram equivalent per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="289.9998" spread="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
        <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
          <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9833" lower_limit="0.983" upper_limit="1.250"/>
                    <measurement group_id="O2" value="0.7583" lower_limit="0.500" upper_limit="3.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
        <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
          <description>Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
          <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.0000" lower_limit="1.000" upper_limit="3.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
        <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863</title>
          <description>Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7699" spread="106.4"/>
                    <measurement group_id="O2" value="61.8251" spread="15.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
        <description>Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2. The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation). Data were not analyzed for radiolabeled oral dose GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863</title>
          <description>Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2. The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.</description>
          <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation). Data were not analyzed for radiolabeled oral dose GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Volume of Distribution at Steady State (Vss) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863</title>
        <description>Plasma samples were collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution at Steady State (Vss) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863</title>
          <description>Plasma samples were collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2355" spread="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vss of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863</title>
        <description>Blood samples were planned to be collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Vss of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863</title>
          <description>Blood samples were planned to be collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
          <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Systemic Clearance (CL) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863</title>
        <description>Plasma samples were collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Systemic Clearance (CL) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863</title>
          <description>Plasma samples were collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Liters per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4779" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863</title>
        <description>Blood samples were planned to be collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>CL of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863</title>
          <description>Blood samples were planned to be collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.</description>
          <population>Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of the Total Radioactive Dose Excreted in Urine Over Time Following a Single, Oral Dose of [14C]-GSK1278863</title>
        <description>Urine samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in urine. All participants were asked to void their bladders before study treatment administration.</description>
        <time_frame>Pre-dose and then over 24 hours collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120,120-144 and 144-168 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of the Total Radioactive Dose Excreted in Urine Over Time Following a Single, Oral Dose of [14C]-GSK1278863</title>
          <description>Urine samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in urine. All participants were asked to void their bladders before study treatment administration.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Percent dose excreted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0-24 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.450" spread="2.7441"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-48 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.838" spread="2.8280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-72 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.003" spread="2.8723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72-96 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.065" spread="2.8744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96-120 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.065" spread="2.8744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120-144 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.065" spread="2.8744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144-168 hours; n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.434" spread="3.0507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of the Total Radioactive Dose Excreted in Feces Over Time Following a Single, Oral Dose of [14C]-GSK1278863</title>
        <description>Fecal samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in feces.</description>
        <time_frame>Pre-dose and then over 24 hour collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of the Total Radioactive Dose Excreted in Feces Over Time Following a Single, Oral Dose of [14C]-GSK1278863</title>
          <description>Fecal samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in feces.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Percent dose excreted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0-24 hours; n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.096" spread="0.1292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-48 hours; n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.298" spread="31.0164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-72 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.988" spread="25.3857"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72-96 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.312" spread="6.0872"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96-120 hours; n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.450" spread="3.1046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120-144 hours; n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.698" spread="2.1027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144-168 hours; n=4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.553" spread="3.6611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of the Total Radioactive Dose Excreted in Urine and Feces Determined as Total Excretion Over Time</title>
        <description>Urine and fecal samples were collected at the indicated time points to determine the rate and extent of cumulative excretion of total radioactivity in urine and feces.</description>
        <time_frame>Pre-dose and then over 24 hour collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of the Total Radioactive Dose Excreted in Urine and Feces Determined as Total Excretion Over Time</title>
          <description>Urine and fecal samples were collected at the indicated time points to determine the rate and extent of cumulative excretion of total radioactivity in urine and feces.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Percent dose excreted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0-24 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.530" spread="2.7223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-48 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.433" spread="28.2968"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-72 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.992" spread="25.9980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72-96 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.377" spread="6.3351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96-120 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.177" spread="2.1428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120-144 hours; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.705" spread="2.0982"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144-168 hours; n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.582" spread="2.3066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC (0-Inf) of GSK1278863 in Plasma Following Administration IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-Inf) of GSK1278863 in Plasma Following Administration IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Hour*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199.2552" spread="16.9"/>
                    <measurement group_id="O2" value="2.6509" spread="27.4"/>
                    <measurement group_id="O3" value="940.2011" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-t) of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-t) of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population</population>
          <units>Hour*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198.1658" spread="16.8"/>
                    <measurement group_id="O2" value="2.6368" spread="20.4"/>
                    <measurement group_id="O3" value="938.5541" spread="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.1190" spread="17.2"/>
                    <measurement group_id="O2" value="2.0058" spread="25.5"/>
                    <measurement group_id="O3" value="544.7022" spread="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1167" lower_limit="1.417" upper_limit="4.000"/>
                    <measurement group_id="O2" value="0.983" lower_limit="0.983" upper_limit="0.983"/>
                    <measurement group_id="O3" value="0.5000" lower_limit="0.500" upper_limit="0.517"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T1/2 of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8786" spread="21.6"/>
                    <measurement group_id="O2" value="2.0653" spread="6.6"/>
                    <measurement group_id="O3" value="2.5037" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC (0-Inf) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863.Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-Inf) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863.Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
          <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
          <units>Hour*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK2391220; n=6,0,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.7699" spread="15.1"/>
                    <measurement group_id="O3" value="139.7713" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; n=6,0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7209" spread="16.3"/>
                    <measurement group_id="O3" value="92.0554" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; n=6,0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6207" spread="15.5"/>
                    <measurement group_id="O3" value="33.1332" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104; n=6,0,5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1180" spread="11.9"/>
                    <measurement group_id="O3" value="140.3785" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; n=6,0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0285" spread="13.1"/>
                    <measurement group_id="O3" value="61.7760" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; n=6,0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4699" spread="21.9"/>
                    <measurement group_id="O3" value="124.1320" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC(0-t) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-t) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
          <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
          <units>Hour*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK2391220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.2574" spread="15.0"/>
                    <measurement group_id="O3" value="142.2907" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2933" spread="16.8"/>
                    <measurement group_id="O3" value="90.9953" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0798" spread="14.1"/>
                    <measurement group_id="O3" value="31.8897" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.3120" spread="11.9"/>
                    <measurement group_id="O3" value="142.3372" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4743" spread="13.4"/>
                    <measurement group_id="O3" value="60.2615" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7836" spread="18.8"/>
                    <measurement group_id="O3" value="122.7102" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population.Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
          <population>Pharmacokinetic Population.Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK2391220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5219" spread="14.4"/>
                    <measurement group_id="O3" value="31.5278" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0391" spread="19.1"/>
                    <measurement group_id="O3" value="25.4542" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8233" spread="16.6"/>
                    <measurement group_id="O3" value="6.8139" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3607" spread="13.5"/>
                    <measurement group_id="O3" value="30.4258" spread="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5279" spread="12.7"/>
                    <measurement group_id="O3" value="13.5590" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4247" spread="23.6"/>
                    <measurement group_id="O3" value="21.9493" spread="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
          <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
          <units>Hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK2391220</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5000" lower_limit="2.983" upper_limit="6.000"/>
                    <measurement group_id="O3" value="2.0000" lower_limit="1.500" upper_limit="4.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5000" lower_limit="1.983" upper_limit="6.000"/>
                    <measurement group_id="O3" value="2.0000" lower_limit="1.500" upper_limit="4.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5000" lower_limit="2.983" upper_limit="6.000"/>
                    <measurement group_id="O3" value="2.0000" lower_limit="2.000" upper_limit="4.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0000" lower_limit="2.983" upper_limit="6.000"/>
                    <measurement group_id="O3" value="2.0000" lower_limit="2.000" upper_limit="4.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5000" lower_limit="2.983" upper_limit="6.000"/>
                    <measurement group_id="O3" value="2.0000" lower_limit="2.000" upper_limit="4.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0000" lower_limit="3.000" upper_limit="6.000"/>
                    <measurement group_id="O3" value="2.0000" lower_limit="2.000" upper_limit="4.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T1/2 of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
        <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
          <group group_id="O3">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses</title>
          <description>Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
          <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
          <units>Hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK2391220; n=6,0, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9805" spread="7.9"/>
                    <measurement group_id="O3" value="3.1506" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2487818; n=6,0, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5744" spread="12.5"/>
                    <measurement group_id="O3" value="1.8644" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506102; n=6,0, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0037" spread="15.9"/>
                    <measurement group_id="O3" value="2.2738" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2506104; n=6,0, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0849" spread="8.0"/>
                    <measurement group_id="O3" value="3.3870" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531398; n=6,0, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7006" spread="14.7"/>
                    <measurement group_id="O3" value="1.9767" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GSK2531401; n=6,0, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3217" spread="12.0"/>
                    <measurement group_id="O3" value="2.9197" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vss of GSK1278863 in Plasma Following IV Dose Administration</title>
        <description>Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Vss of GSK1278863 in Plasma Following IV Dose Administration</title>
          <description>Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Liter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3387" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vss of GSK1278863 Metabolites in Plasma Following IV Dose Administration</title>
        <description>Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Vss of GSK1278863 Metabolites in Plasma Following IV Dose Administration</title>
          <description>Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
          <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK2391220</title>
            </class>
            <class>
              <title>GSK2487818</title>
            </class>
            <class>
              <title>GSK2506102</title>
            </class>
            <class>
              <title>GSK2506104</title>
            </class>
            <class>
              <title>GSK2531398</title>
            </class>
            <class>
              <title>GSK2531401</title>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CL of GSK1278863 in Plasma Following IV Dose Administration</title>
        <description>Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>CL of GSK1278863 in Plasma Following IV Dose Administration</title>
          <description>Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Liter per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8612" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CL of GSK1278863 Metabolites in Plasma Following IV Dose Administration</title>
        <description>Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>CL of GSK1278863 Metabolites in Plasma Following IV Dose Administration</title>
          <description>Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</description>
          <population>Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GSK2391220</title>
            </class>
            <class>
              <title>GSK2487818</title>
            </class>
            <class>
              <title>GSK2506102</title>
            </class>
            <class>
              <title>GSK2506104</title>
            </class>
            <class>
              <title>GSK2531398</title>
            </class>
            <class>
              <title>GSK2531401</title>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Bioavailability of GSK1278863 Following Oral Dosing</title>
        <description>Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as ratio of AUC(oral)/Dose(oral) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses administered in treatment period 1 was analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.</description>
        <time_frame>Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet</title>
            <description>Participants received a single 6 mg oral tablet of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Bioavailability of GSK1278863 Following Oral Dosing</title>
          <description>Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as ratio of AUC(oral)/Dose(oral) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses administered in treatment period 1 was analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Ratio of dose normalized AUC</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC (0-inf); n=3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6575" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC (0-t); n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6263" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Radioactivity Recovered for Each Metabolite in Plasma Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</title>
        <description>Blood samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. 2 pooled plasma samples were prepared. Aliquots of plasma samples collected between 0 to 8 hours post-dose from each participant were pooled in proportion to the time intervals. An equal amount of the individual pools from each participant was then pooled to create 1 plasma sample that was representative of the mean area under curve over the range of 0-8 hour. The second pool (10-12 hours pool) was obtained by mixing equal volume of the plasma samples at 10 and 12 hour across all participants. Percent radioactivity recovered for each metabolite in plasma following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
        <time_frame>0-8 hours, 10-12 hours in period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Radioactivity Recovered for Each Metabolite in Plasma Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</title>
          <description>Blood samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. 2 pooled plasma samples were prepared. Aliquots of plasma samples collected between 0 to 8 hours post-dose from each participant were pooled in proportion to the time intervals. An equal amount of the individual pools from each participant was then pooled to create 1 plasma sample that was representative of the mean area under curve over the range of 0-8 hour. The second pool (10-12 hours pool) was obtained by mixing equal volume of the plasma samples at 10 and 12 hour across all participants. Percent radioactivity recovered for each metabolite in plasma following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
          <population>Pharmacokinetic Population</population>
          <units>Percent radioactivity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M2 (GSK2391220) and M33 combined, 0-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M2 (GSK2391220) and M33 combined, 10-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3 (GSK2506104), 0-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3 (GSK2506104), 10-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M4 (GSK2487818), 0-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M4 (GSK2487818), 10-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data is not available since concentration of metabolite was not detected in the sample.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6 (GSK2531398), 0-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6 (GSK2531398), 10-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data is not available as all concentration values were less than the lower limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M13 (GSK2531401), 0-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M13 (GSK2531401), 10-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M5 (GSK2506102) and M14 combined, 0-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M5 (GSK2506102) and M14 combined, 10-12 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data is not available as all concentration values were less than the lower limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Radioactivity Recovered for Each Metabolite in Urine Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</title>
        <description>Urine samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled urine sample was prepared by urine collected from 0 to 24 hours post dose from all participants. Percent radioactivity recovered for each metabolite in urine following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
        <time_frame>0-24 hours in period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Radioactivity Recovered for Each Metabolite in Urine Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</title>
          <description>Urine samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled urine sample was prepared by urine collected from 0 to 24 hours post dose from all participants. Percent radioactivity recovered for each metabolite in urine following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
          <population>Pharmacokinetic Population</population>
          <units>Percent radioactivity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M2 (GSK2391220) and M33 combined</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3 (GSK2506104)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M4 (GSK2487818)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6 (GSK2531398)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M13 (GSK2531401)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M5 (GSK2506102) and M14 combined</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Radioactivity Recovered for Each Metabolite in Feces Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</title>
        <description>Feces samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled feces sample was prepared by samples collected from 0 to 120 hours post dose from all participants. Percent radioactivity recovered for each metabolite in feces following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
        <time_frame>0-120 hours in period 2</time_frame>
        <population>Pharmacokinetic Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Radioactivity Recovered for Each Metabolite in Feces Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg</title>
          <description>Feces samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled feces sample was prepared by samples collected from 0 to 120 hours post dose from all participants. Percent radioactivity recovered for each metabolite in feces following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.</description>
          <population>Pharmacokinetic Population</population>
          <units>Percent radioactivity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M2 (GSK2391220)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3 (GSK2506104)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M4 (GSK2487818)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6 (GSK2531398)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M13 (GSK2531401)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M5 (GSK2506102) and M14 combined</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Radioactivity Recovered for Each Metabolite in Duodenal Bile Following a Single Dose of [14C]-GSK1278863 50 µg IV Infusion</title>
        <description>The bile string was swallowed by participants prior to oral dose and was removed 3 hours after the oral dose (1 hour after the end of the IV infusion) in treatment period-1. Duodenal bile string extracts were pooled to create a single pool sample to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single dose of [14C]-GSK1278863 50 µg IV infusion. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102). Mean percent radioactivity recovered for each metabolite in bile following a single dose of [14C]-GSK1278863 50 µg IV infusion is presented.</description>
        <time_frame>3 hours post-oral dose in period 1</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour in treatment period 1, after approximately 1 hour of receiving GSK1278863 6 mg Oral tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Radioactivity Recovered for Each Metabolite in Duodenal Bile Following a Single Dose of [14C]-GSK1278863 50 µg IV Infusion</title>
          <description>The bile string was swallowed by participants prior to oral dose and was removed 3 hours after the oral dose (1 hour after the end of the IV infusion) in treatment period-1. Duodenal bile string extracts were pooled to create a single pool sample to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single dose of [14C]-GSK1278863 50 µg IV infusion. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102). Mean percent radioactivity recovered for each metabolite in bile following a single dose of [14C]-GSK1278863 50 µg IV infusion is presented.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Percent radioactivity</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M2 (GSK2391220)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M3 (GSK2506104)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M4 (GSK2487818)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M6 (GSK2531398)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M13 (GSK2531401)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per Medical or scientific judgment. Safety Population comprised of all participants who take at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.</description>
        <time_frame>Up to 43 days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per Medical or scientific judgment. Safety Population comprised of all participants who take at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AEs at a Particular Severity</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity was categorized as mild, moderate and severe. The number of participants with AEs at any type of severity (mild, moderate and severe) has been presented.</description>
        <time_frame>Up to 43 days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AEs at a Particular Severity</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity was categorized as mild, moderate and severe. The number of participants with AEs at any type of severity (mild, moderate and severe) has been presented.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range</title>
        <description>Blood samples were collected from participants at indicated time points for the analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Protein, Sodium and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (example given [e.g.], High to High), or whose value became normal, are recorded in the &quot;To Normal or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.</description>
        <time_frame>Up to 43 days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range</title>
          <description>Blood samples were collected from participants at indicated time points for the analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Protein, Sodium and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (example given [e.g.], High to High), or whose value became normal, are recorded in the &quot;To Normal or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT;To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alk Phos; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alk Phos; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alk Phos; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST;To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea;To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Worst Case Hematology Results Relative to Normal Range</title>
        <description>Blood samples were collected from participants at indicated time points for the analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes, and Reticulocytes/Erythrocytes. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the &quot;To Normal or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.</description>
        <time_frame>Up to 43 days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Hematology Results Relative to Normal Range</title>
          <description>Blood samples were collected from participants at indicated time points for the analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes, and Reticulocytes/Erythrocytes. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the &quot;To Normal or No Change&quot; category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCH; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCH; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCH; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCV; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCV; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCV; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes/Erythrocytes; To Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes/Erythrocytes; To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes/Erythrocytes; To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Urinalysis Findings</title>
        <description>Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity and PH of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine.</description>
        <time_frame>Up to 43 days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Urinalysis Findings</title>
          <description>Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity and PH of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine.</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings</title>
        <description>Full 12-lead ECGs were recorded with the participant in a supine position. The number of participants with abnormal ECG findings at indicated time points were presented. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
        <time_frame>Pre-dose (on Day 1) and Day 8 in treatment period 2; 144 hours (Day 7) in treatment period 1</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings</title>
          <description>Full 12-lead ECGs were recorded with the participant in a supine position. The number of participants with abnormal ECG findings at indicated time points were presented. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose (Day 1); n=0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours (Day 7); n= 6, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8; n=0, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Pressure</title>
        <description>Vital sign including systolic and diastolic blood pressure were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Average [Avg] Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
        <time_frame>Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Pressure</title>
          <description>Vital sign including systolic and diastolic blood pressure were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Average [Avg] Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP; Avg 3 hours; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="5.722"/>
                    <measurement group_id="O2" value="-1.22" spread="3.468"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP; Avg 144 hours (Day 7); n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.06" spread="10.521"/>
                    <measurement group_id="O2" value="-2.00" spread="9.541"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP; Avg Day 8; n=0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.22" spread="4.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; Avg 3 hours; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="5.484"/>
                    <measurement group_id="O2" value="0.89" spread="4.834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; Avg 144 hours (Day 7); n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" spread="9.365"/>
                    <measurement group_id="O2" value="-1.00" spread="9.814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; Avg Day 8; n=0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.39" spread="5.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heart Rate</title>
        <description>Heart rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Avg Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
        <time_frame>Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heart Rate</title>
          <description>Heart rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Avg Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Avg 3 hours; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="3.526"/>
                    <measurement group_id="O2" value="1.67" spread="3.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Avg 144 hours (Day 7); n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="6.571"/>
                    <measurement group_id="O2" value="3.78" spread="5.500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Avg Day 8; n=0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.72" spread="5.535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Respiratory Rate</title>
        <description>Respiratory rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
        <time_frame>Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Rate</title>
          <description>Respiratory rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 hours; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.67" spread="2.422"/>
                    <measurement group_id="O2" value="-0.33" spread="4.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours (Day 7); n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="2.066"/>
                    <measurement group_id="O2" value="-0.33" spread="1.506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8; n=0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.00" spread="2.530"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Temperature</title>
        <description>Body temperature measurement was performed in participants at indicated time points. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
        <time_frame>Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
            <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK1278863 25 mg Oral Solution</title>
            <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Temperature</title>
          <description>Body temperature measurement was performed in participants at indicated time points. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Celsius</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 hours; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.183"/>
                    <measurement group_id="O2" value="0.25" spread="0.455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours (Day 7); n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.446"/>
                    <measurement group_id="O2" value="0.12" spread="0.588"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8; n=0,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.30" spread="0.693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected from the start of the study treatment up to 43 days.</time_frame>
      <desc>SAEs and Non-SAEs were reported by treatment for the Safety Population which comprised of all participants who had taken at least 1 dose of study treatment</desc>
      <group_list>
        <group group_id="E1">
          <title>GSK1278863 6 mg Oral Tablet+[14C]-GSK1278863 50 µg IV Infusion</title>
          <description>Participants received a single 6 mg oral dose of GSK1278863 on Day 1 of treatment period 1, after an overnight fast of at least 8 hours. After approximately 1 hour, participants received 50 µg [14C]-GSK1278863 by IV infusion over 1 hour.</description>
        </group>
        <group group_id="E2">
          <title>[14C]-GSK1278863 25 mg Oral Solution</title>
          <description>Participants received 25 mg [14C]-GSK1278863 as an oral solution, after an overnight fast of at least 8 hours in treatment period 2.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03239522
org study id: 200232
secondary id: 2017-001729-42
nct id: NCT03239522
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Absorption, metabolism and excretion of daprodustat (GSK1278863) have been studied in
      previous clinical trials; however, the elimination routes and metabolic pathways of
      daprodustat have not been fully elucidated in humans. This is an open-label, single-center,
      non-randomized, 2-period, single-sequence, crossover, mass balance study in 6 healthy male
      participants. The aim of the study is to assess the excretion balance of daprodustat using
      [14C]-radiolabeled drug substance administered orally, and as an intravenous (IV) infusion,
      administered as a microtracer dose (concomitant with an oral, non-radiolabeled dose).
      Absolute bioavailability of an oral dose will also be assessed. Each participant will be
      involved in the study for up to 10 weeks which include a screening visit, two treatment
      periods (treatment periods 1 and 2), separated by about 7 days (at least 14 days between oral
      doses), and a follow up visit 1-2 weeks after the last assessment in treatment period 2. The
      primary objective of the study is to gain a better understanding of the compound's excretory
      and metabolic profile. This study will include sampling of duodenal bile to conduct
      qualitative assessment of drug metabolites in this matrix in order to characterize biliary
      elimination pathways.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-Inf]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable [NQ] values were considered as non-missing values).
measure: AUC (0-Inf) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf). The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.
measure: AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: AUC (0-t) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.
measure: Maximum Observed Plasma Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: Cmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.
measure: Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: Tmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.
measure: Apparent Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: T1/2 of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2. The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.
measure: Volume of Distribution at Steady State (Vss) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Plasma samples were collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: Vss of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Blood samples were planned to be collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.
measure: Total Systemic Clearance (CL) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Plasma samples were collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: CL of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Blood samples were planned to be collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.
measure: Percentage of the Total Radioactive Dose Excreted in Urine Over Time Following a Single, Oral Dose of [14C]-GSK1278863
time frame: Pre-dose and then over 24 hours collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120,120-144 and 144-168 hours post-dose in treatment period 2
description: Urine samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in urine. All participants were asked to void their bladders before study treatment administration.
measure: Percentage of the Total Radioactive Dose Excreted in Feces Over Time Following a Single, Oral Dose of [14C]-GSK1278863
time frame: Pre-dose and then over 24 hour collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2
description: Fecal samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in feces.
measure: Percentage of the Total Radioactive Dose Excreted in Urine and Feces Determined as Total Excretion Over Time
time frame: Pre-dose and then over 24 hour collection periods as follows: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2
description: Urine and fecal samples were collected at the indicated time points to determine the rate and extent of cumulative excretion of total radioactivity in urine and feces.
measure: AUC (0-Inf) of GSK1278863 in Plasma Following Administration IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: AUC(0-t) of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: Cmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: Tmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: T1/2 of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: AUC (0-Inf) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863.Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.
measure: AUC(0-t) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.
measure: Cmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.
measure: Tmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.
measure: T1/2 of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2
description: Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.
measure: Vss of GSK1278863 in Plasma Following IV Dose Administration
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: Vss of GSK1278863 Metabolites in Plasma Following IV Dose Administration
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.
measure: CL of GSK1278863 in Plasma Following IV Dose Administration
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
measure: CL of GSK1278863 Metabolites in Plasma Following IV Dose Administration
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.
measure: Absolute Bioavailability of GSK1278863 Following Oral Dosing
time frame: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1
description: Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as ratio of AUC(oral)/Dose(oral) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses administered in treatment period 1 was analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.
measure: Percent Radioactivity Recovered for Each Metabolite in Plasma Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg
time frame: 0-8 hours, 10-12 hours in period 2
description: Blood samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. 2 pooled plasma samples were prepared. Aliquots of plasma samples collected between 0 to 8 hours post-dose from each participant were pooled in proportion to the time intervals. An equal amount of the individual pools from each participant was then pooled to create 1 plasma sample that was representative of the mean area under curve over the range of 0-8 hour. The second pool (10-12 hours pool) was obtained by mixing equal volume of the plasma samples at 10 and 12 hour across all participants. Percent radioactivity recovered for each metabolite in plasma following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.
measure: Percent Radioactivity Recovered for Each Metabolite in Urine Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg
time frame: 0-24 hours in period 2
description: Urine samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled urine sample was prepared by urine collected from 0 to 24 hours post dose from all participants. Percent radioactivity recovered for each metabolite in urine following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.
measure: Percent Radioactivity Recovered for Each Metabolite in Feces Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg
time frame: 0-120 hours in period 2
description: Feces samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled feces sample was prepared by samples collected from 0 to 120 hours post dose from all participants. Percent radioactivity recovered for each metabolite in feces following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.
measure: Percent Radioactivity Recovered for Each Metabolite in Duodenal Bile Following a Single Dose of [14C]-GSK1278863 50 µg IV Infusion
time frame: 3 hours post-oral dose in period 1
description: The bile string was swallowed by participants prior to oral dose and was removed 3 hours after the oral dose (1 hour after the end of the IV infusion) in treatment period-1. Duodenal bile string extracts were pooled to create a single pool sample to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single dose of [14C]-GSK1278863 50 µg IV infusion. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102). Mean percent radioactivity recovered for each metabolite in bile following a single dose of [14C]-GSK1278863 50 µg IV infusion is presented.
measure: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
time frame: Up to 43 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per Medical or scientific judgment. Safety Population comprised of all participants who take at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
measure: Number of Participants With AEs at a Particular Severity
time frame: Up to 43 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity was categorized as mild, moderate and severe. The number of participants with AEs at any type of severity (mild, moderate and severe) has been presented.
measure: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range
time frame: Up to 43 days
description: Blood samples were collected from participants at indicated time points for the analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Protein, Sodium and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (example given [e.g.], High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
measure: Number of Participants With Worst Case Hematology Results Relative to Normal Range
time frame: Up to 43 days
description: Blood samples were collected from participants at indicated time points for the analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes, and Reticulocytes/Erythrocytes. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment.
measure: Number of Participants With Abnormal Urinalysis Findings
time frame: Up to 43 days
description: Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity and PH of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine.
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
time frame: Pre-dose (on Day 1) and Day 8 in treatment period 2; 144 hours (Day 7) in treatment period 1
description: Full 12-lead ECGs were recorded with the participant in a supine position. The number of participants with abnormal ECG findings at indicated time points were presented. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.
measure: Change From Baseline in Blood Pressure
time frame: Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2
description: Vital sign including systolic and diastolic blood pressure were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Average [Avg] Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.
measure: Change From Baseline in Heart Rate
time frame: Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2
description: Heart rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Avg Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.
measure: Change From Baseline in Respiratory Rate
time frame: Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2
description: Respiratory rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.
measure: Change From Baseline in Body Temperature
time frame: Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2
description: Body temperature measurement was performed in participants at indicated time points. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.
arm group label: All participants receiving treatment
arm group type: Experimental
description: Each participant will receive a single 6 milligram (mg) oral dose of daprodustat on Day 1 of period 1. After approximately 1 hour, participants will receive 50 microgram (µg) of [14C]-GSK1278863 by IV infusion over 1 hour. On Day 1 of period 2, each participant will receive 25 mg [14C]-GSK1278863 as an oral solution.
intervention type: Drug
intervention name: [14C]-GSK1278863 solution for IV infusion
description: It is a clear, colorless solution free from visible particulate matter. Participants will receive 10 mL of 5 µg/mL of [14C]-GSK1278863 IV solution (total dose: 50 µg) by IV infusion over 1 hour.
arm group label: All participants receiving treatment
intervention type: Drug
intervention name: [14C]-GSK1278863 oral solution
description: It is a clear, colorless solution. Participants will receive 125 mL of 200 µg/mL of [14C]-GSK1278863 oral solution (total dose: 25 mg).
arm group label: All participants receiving treatment
intervention type: Drug
intervention name: Daprodustat 6 mg oral tablet
description: It is a 9.0 millimeter (mm) round, white film coated tablet.
arm group label: All participants receiving treatment
criteria: 
gender: Male
gender based: Yes
gender description: Only male participants, aged 30 to 55 years (inclusive) will be enrolled into the study.
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pharmaceutical Solutions
mesh term: Glycine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 