<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/NCT04507321</url>
  </required_header>
  <id_info>
    <org_study_id>213051</org_study_id>
    <secondary_id>2019-004444-30</secondary_id>
    <nct_id>NCT04507321</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Metabolism of 14 Carbon [14C]-GSK3640254</brief_title>
  <official_title>A Two-period Study in Healthy Male Participants to Determine the Pharmacokinetics, Balance/Excretion, and Metabolism of [14C]-GSK3640254 Following a Single Intravenous Radiolabeled Microtracer Dose (Concomitant With a Non-radiolabeled Oral Dose) and a Single Oral Radiolabeled Dose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ViiV Healthcare</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-center, single group, non-randomized, two-period, single&#xD;
      sequence, mass balance study which will enroll 6 healthy male participants. This study will&#xD;
      assess the pharmacokinetics, balance/excretion, and metabolism of GSK3640254 in humans using&#xD;
      [14C]-radiolabeled drug substance administered as an intravenous (IV) infusion and via the&#xD;
      oral route. The study will also provide an assessment of GSK3640254 absorption, metabolism&#xD;
      and excretion following administration of a [14C]-radiolabeled oral suspension. Each&#xD;
      participant will be involved in the study for up to 10 weeks which will include a screening&#xD;
      period, two treatment periods (treatment Periods 1 and 2) separated by a washout of at least&#xD;
      13 days between oral doses, and a follow-up visit 7-14 days after the last assessment in&#xD;
      treatment Period 2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants will receive non-radiolabeled GSK3640254 oral tablets concomitantly with radiolabeled [14C]-GSK3640254 administered as an IV infusion in treatment Period 1 and radiolabeled [14C]-GSK3640254 as an oral suspension in treatment Period 2.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This will be an open-label study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) in Plasma Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for Pharmacokinetic (PK) analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as AUC(0-inf) is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) in Plasma Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC (0-t) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Concentration (Cmax) in Plasma Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Occurrence of Cmax (Tmax) in Plasma Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Phase Half-life (T1/2) in Plasma Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as T1/2 is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution at Steady State (Vss) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance (CL) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal Clearance (CLr) Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative amount [Ae][Urine] for Period 1)/(Plasma AUC[0-inf]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CLr Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative Ae[Urine] for Period 2)/(Plasma AUC[0-inf]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Clearance (CL/F) in Plasma Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F in Plasma Following Administration Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) Following Administration of Oral Dose of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vz/F Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Oral Bioavailability of GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</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 Tablet)/Dose(Oral Tablet) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses were analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Drug Escaping First Pass Hepatic Clearance (Fh) Following Administration of [14C]-GSK3640254 IV</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. Fh was expressed as percentage and was calculated as: 1 minus hepatic extraction ratio multiplied by 100. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Drug Absorbed (Fa) Following Administration of [14C]-GSK3640254 Oral Suspension</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. Fa was expressed as percentage which was calculated as ratio of oral bioavailability and Fh multiplied by 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Drug Escaping Gut Metabolism (Fg) Following Administration of [14C]-GSK3640254 Oral Suspension</measure>
    <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
    <description>Blood samples were collected at the indicated time points for PK analysis. Fg is defined as the fraction metabolized by gut wall as a fraction of the oral dose and was expressed as 1 minus Metabolite load following intravenous and oral administration multiplied by 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Total Radioactive Dose Excreted in Urine Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 5, 24, 48, 72, 96, 120, 144 and 163 hours post-dose</time_frame>
    <description>Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100. Not applicable (NA) indicates that No concentration values detected for pre-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Total Radioactive Dose Excreted in Urine Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose</time_frame>
    <description>Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Total Radioactive Dose Excreted in Feces Following Administration of IV Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144 and 163 hours post-dose</time_frame>
    <description>Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100. NA indicates that No concentration values detected for pre-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Total Radioactive Dose Excreted in Feces Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose</time_frame>
    <description>Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)</measure>
    <time_frame>Up to 50 days</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose 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 or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to [&gt;=]5 percent [%]) non-serious AEs and SAEs is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst Case Hematology Results Relative to Normal Range Post Baseline Relative to Baseline</measure>
    <time_frame>Baseline (Day 1: pre-dose) and Up to 50 Days</time_frame>
    <description>Blood samples were collected to analyze following hematology parameters; Basophils, Eosinophils, Erythrocytes mean corpuscular hemoglobin (MCH), Erythrocytes mean corpuscular volume (MCV), Erythrocytes, Hematocrit (HCT), Hemoglobin (Hb), Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes and Reticulocytes/Erythrocytes. Participants were counted in worst case category if their value changed to (low, normal or high), unless there was no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.] High to High), or whose value became normal, were 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%. Baseline value=latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post Baseline Relative to Baseline</measure>
    <time_frame>Baseline (Day 1: pre-dose) and Up to 50 Days</time_frame>
    <description>Blood samples were collected to analyze following clinical chemistry parameters:Alanine aminotransferase(ALT),albumin,alkaline phosphatase(ALP),aspartate aminotransferase(AST),bilirubin,calcium,chloride,cholesterol,creatinine,direct bilirubin,globulin,glucose,high-density lipoprotein (HDL) cholesterol,low-density lipoprotein (LDL) cholesterol,phosphate,potassium,protein,sodium,triglycerides,urate and urea.Participants were counted in worst case category if their value changed to(low,normal or high),unless there was no change in their category.Participants whose laboratory value category was unchanged(e.g. High to High),or whose value became normal,were 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%.Baseline value=latest pre-dose assessment(prior to oral dose) in each treatment period,with a non-missing value,including those from unscheduled visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Urinalysis Findings</measure>
    <time_frame>Up to 50 days</time_frame>
    <description>Urine samples were collected to detect the presence of bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, protein and urobilinogen. Urinalysis also included measurement of specific gravity and potential of Hydrogen (pH). Number of participants with clinically significant urinalysis findings are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Worst Case Post Baseline Abnormal 12-Lead Electrocardiogram (ECG) Findings</measure>
    <time_frame>Baseline (Day 1: pre-dose) and Up to 50 days</time_frame>
    <description>12-lead ECGs were recorded with the participants in semi-supine position after 5 minutes rest using an automated ECG machine that measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal, not clinically significant (NCS) and Clinically significant (CS) ECG findings for worst case post-Baseline are presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8</time_frame>
    <description>SBP and DBP were measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pulse Rate</measure>
    <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8</time_frame>
    <description>Pulse rate was measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Rate</measure>
    <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8</time_frame>
    <description>Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Temperature</measure>
    <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours), 36, 72, 96, 120, 144, 168 hours and Day 8</time_frame>
    <description>Temperature was measured in semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Weight</measure>
    <time_frame>Baseline (Day 1: pre-dose) and up to Day 8</time_frame>
    <description>Weight was measured and recorded. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Radioactivity in Blood to Plasma Following Administration of Oral Dose of [14C]-GSK3640254</measure>
    <time_frame>Day 1: 2, 4, 6, 8 and 10 hours</time_frame>
    <description>Blood samples were collected at the indicated time points for analysis of total radioactivity in blood to plasma. It was calculated as Radioactivity Concentration in blood (Cb) divided by Radioactivity Concentration in plasma (Cp).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal. Participants will then be administered a 100 microgram (mcg) dose (approximately 3.7 kilobecquerel; 100 nano Curie) of [14C]-GSK3640254 as an IV infusion for 1 hour on Day 1 in treatment Period 1, On Day 1 in treatment Period 2, participants will receive a single oral dose of 85 mg (approximately 3.15 megabecquerel; 85 micro Curie) [14C]-GSK3640254 administered as an oral suspension with a moderate fat meal. A wash out period of at least 13 days will be maintained between oral doses of treatment periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK3640254 Oral tablet</intervention_name>
    <description>GSK3640254 will be available as white film-coated round tablets to be administered via oral route with meal in the morning with 240 milliliter (mL) of water at room temperature.</description>
    <arm_group_label>GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-GSK3640254 intravenous infusion</intervention_name>
    <description>[14C]-GSK3640254 will be available as clear, colorless solution free from visible particulates to be administered via the IV route.</description>
    <arm_group_label>GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-GSK3640254 powder</intervention_name>
    <description>[14C]-GSK3640254 will be available as white powder to be reconstituted into a suspension with 25 mL of vehicle before dosing so as to administer 85 mg dose with meal in the morning.</description>
    <arm_group_label>GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must be 30 to 50 years of age inclusive, at the time of signing the&#xD;
             informed consent.&#xD;
&#xD;
          -  Participants who are overtly healthy as determined by medical evaluation including&#xD;
             medical history, physical examination, laboratory tests, vital signs and ECG. A&#xD;
             participant with a clinical abnormality or laboratory parameter (i.e. outside the&#xD;
             reference range for the population being studied), which is not specifically listed in&#xD;
             the eligibility criteria, may be included only if the investigator agrees and&#xD;
             documents that the finding is unlikely to introduce additional risk factors and will&#xD;
             not interfere with the study procedures.&#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 kilograms (kg) and above, and body mass index (BMI) within the range&#xD;
             19.0 to 31.0 kg/square meter (m^2) (inclusive).&#xD;
&#xD;
          -  Male participants are eligible to participate if they agree to the following during&#xD;
             the study, including washout periods: Refrain from donating sperm and either a) be&#xD;
             abstinent from heterosexual intercourse as their preferred and usual lifestyle&#xD;
             (abstinent on a long term and persistent basis) and agree to remain abstinent or b)&#xD;
             Agree to use a male condom when having penile-vaginal intercourse with a woman of&#xD;
             childbearing potential unless vasectomized.&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#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;
          -  Significant history of or current cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal, endocrine, hematological, or neurological disorders capable of&#xD;
             significantly altering the absorption, metabolism, or elimination of drugs;&#xD;
             constituting a risk when taking the study intervention; or interfering with the&#xD;
             interpretation of data.&#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;
          -  Current episode, recent history, or chronic history of diarrhea.&#xD;
&#xD;
          -  Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or&#xD;
             squamous epithelial carcinomas of the skin that have been resected with no evidence of&#xD;
             metastatic disease for 3 years.&#xD;
&#xD;
          -  Any history of significant underlying psychiatric disorder, including, but not limited&#xD;
             to, schizophrenia, bipolar disorder with or without psychotic symptoms, other&#xD;
             psychotic disorders, or schizotypal (personality) disorder.&#xD;
&#xD;
          -  Any history of major depressive disorder with or without suicidal features, or anxiety&#xD;
             disorders that required medical intervention (pharmacologic or not) such as&#xD;
             hospitalization or other inpatient treatment and/or chronic (&gt;6 months) outpatient&#xD;
             treatment. Participants with other conditions such as adjustment disorder or dysthymia&#xD;
             that have required shorter term medical therapy (&lt;6 months) without inpatient&#xD;
             treatment and are currently well-controlled clinically or resolved may be considered&#xD;
             for entry after discussion and agreement with the ViiV Healthcare (VH)/GlaxoSmithKline&#xD;
             (GSK) Medical Monitor.&#xD;
&#xD;
          -  Any pre-existing physical or other psychiatric condition (including alcohol or drug&#xD;
             abuse), which, in the opinion of the investigator (with or without psychiatric&#xD;
             evaluation), could interfere with the participant's ability to comply with the dosing&#xD;
             schedule and protocol.&#xD;
&#xD;
          -  Regular use of known drugs of abuse or history of drug abuse or dependence within 6&#xD;
             months of the study.&#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 grams of alcohol: a glass&#xD;
             (equivalent to [~]240 mL) of beer, 1 small glass (~100 mL) of wine or 1 (~25 mL)&#xD;
             measure of spirits.&#xD;
&#xD;
          -  History of or regular use of tobacco- or nicotine-containing products in the 3 months&#xD;
             prior to Screening.&#xD;
&#xD;
          -  Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3&#xD;
             months, or cardiac disease or a family or personal history of long QT syndrome.&#xD;
&#xD;
          -  QT duration corrected for heart rate by Fridericia's formula (QTcF) &gt;450 milliseconds&#xD;
             (msec).&#xD;
&#xD;
          -  At Screening or prior to the first dose, a supine blood pressure (BP) that is&#xD;
             persistently higher than 140/90 millimeters of mercury (mmHg).&#xD;
&#xD;
          -  At Screening or prior to the first dose, a supine mean heart rate (HR) outside the&#xD;
             range of 50 to 100 beats per minute (bpm). A heart rate from 100 to 110 bpm can be&#xD;
             rechecked by ECG or vital signs within 30 minutes to verify eligibility.&#xD;
&#xD;
          -  A participant with known or suspected active COVID-19 infection OR contact with an&#xD;
             individual with known COVID-19, within 14 days of study enrollment.&#xD;
&#xD;
          -  Past or intended use of over-the-counter or prescription medication, including&#xD;
             analgesics (example [e.g], paracetamol), herbal medications, or grapefruit and Seville&#xD;
             orange juices within 14 days prior to the first dose of study intervention until&#xD;
             completion of the follow-up visit unless approved by the Investigator in conjunction&#xD;
             with a VH/GSK Medical monitor.&#xD;
&#xD;
          -  Treatment with any vaccine within 30 days prior to receiving study intervention.&#xD;
&#xD;
          -  Current enrollment in a clinical trial; recent participation in a clinical trial and&#xD;
             has received an investigational product within 3 months before the first dose in the&#xD;
             current study.&#xD;
&#xD;
          -  Exposure to more than 4 new chemical entities within 12 months before the 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 International Commission on Radiological Protection [ICRP] category II) or&#xD;
             exposure to significant radiation (e.g., serial x-ray or computed tomography [CT]&#xD;
             scans, barium meal, etc.) in the 3 years before this study.&#xD;
&#xD;
          -  Alanine transaminase (ALT) &gt;=1.5 times upper limit of normal (ULN). A single repeat of&#xD;
             ALT is allowed within a single Screening period to determine eligibility.&#xD;
&#xD;
          -  Bilirubin &gt;=1.5 times ULN (isolated bilirubin &gt;=1.5 times ULN is acceptable if&#xD;
             bilirubin is fractionated and direct bilirubin &lt;35 percent (%). A single repeat of any&#xD;
             laboratory abnormality is allowed within a single Screening period to determine&#xD;
             eligibility.&#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;
             intervention and positive on reflex to hepatitis C ribonucleic acid (RNA).&#xD;
&#xD;
          -  Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.&#xD;
&#xD;
          -  Any positive (abnormal) response confirmed by the investigator or qualified&#xD;
             designee-administered Columbia-Suicide Severity Rating Scale (C-SSRS).&#xD;
&#xD;
          -  Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of creatine&#xD;
             phosphokinase (CPK) and lipid abnormalities (e.g., total cholesterol, triglycerides),&#xD;
             and ALT (described above), will exclude a participant from the study unless the&#xD;
             investigator can provide a compelling explanation for the laboratory result(s) and has&#xD;
             the assent of the sponsor. A single repeat of any laboratory abnormality (other than a&#xD;
             viral Screening test for HIV-1/2, hepatitis B Virus [HBV], or hepatitis C Virus [HCV])&#xD;
             is allowed within a single Screening period to determine eligibility.&#xD;
&#xD;
          -  Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the&#xD;
             past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias,&#xD;
             non-sustained or sustained ventricular tachycardia, second-degree atrioventricular&#xD;
             block Mobitz Type II, third-degree atrioventricular block, complete heart block, or&#xD;
             conduction abnormality) which, in the opinion of the investigator or VH/GSK Medical&#xD;
             Monitor, will interfere with the safety for the individual participant. Any acute&#xD;
             laboratory abnormality at Screening which, in the opinion of the investigator, should&#xD;
             preclude participation in the study of an investigational compound.&#xD;
&#xD;
          -  Has had an occupation which requires monitoring for radiation exposure, nuclear&#xD;
             medicine procedures, or excessive x-rays within the past 3 years.&#xD;
&#xD;
          -  Loss of more than 400 mL blood during the 3 months before Screening, e.g., as a blood&#xD;
             donor, or plan to donate blood or blood products in the 3 months after the end of the&#xD;
             trial.&#xD;
&#xD;
          -  Unwillingness or inability to follow the procedures outlined in the protocol,&#xD;
             including the use of the string bile collection device.&#xD;
&#xD;
          -  History of sensitivity to GSK3640254, 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>Male participants will be part of this study.</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 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>ViiV Healthcare</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 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <results_first_submitted>November 19, 2021</results_first_submitted>
  <results_first_submitted_qc>November 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 31, 2022</results_first_posted>
  <last_update_submitted>November 19, 2021</last_update_submitted>
  <last_update_submitted_qc>November 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Human Immunodeficiency Virus (HIV)</keyword>
  <keyword>GSK3640254</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Radiolabeled</keyword>
  <keyword>Mass balance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <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>June 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04507321/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>September 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04507321/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was an open-label, non-randomized, 2-period, single-sequence study to determine the pharmacokinetics, balance/excretion, and metabolism of radiolabeled [14C]-GSK3640254 following a single intravenous radiolabeled microtracer dose and a single oral radiolabeled dose. The study was conducted at a single center in the United Kingdom.</recruitment_details>
      <pre_assignment_details>A total of 5 participants were enrolled in the study. The washout time between dosing in consecutive study periods was at least 13 days.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GSK3640254 Tablet+[14C]-GSK3640254 IV/ [14C]-GSK3640254 Oral Suspension</title>
          <description>Participants were administered a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal, followed by an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1. In Treatment Period 2 on Day 1, participants were administered a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal. The treatment periods were separated by a washout period of at least 13 days between oral doses.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 (8 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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 (8 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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>GSK3640254 Tablet+[14C]-GSK3640254 IV/ [14C]-GSK3640254 Oral Suspension</title>
          <description>Participants were administered a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal, followed by an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1. In Treatment Period 2 on Day 1, participants were administered a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal. The treatment periods were separated by a washout period of at least 13 days between oral doses.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </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="37.4" spread="5.41"/>
                  </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="5"/>
                  </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>Asian- Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White- White/Caucasian/European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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]) in Plasma Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for Pharmacokinetic (PK) analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population comprised of all participants in the Safety Population (all participants who took atleast one dose of study intervention) who had at least 1 non-missing PK assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) in Plasma Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for Pharmacokinetic (PK) analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population comprised of all participants in the Safety Population (all participants who took atleast one dose of study intervention) who had at least 1 non-missing PK assessment.</population>
          <units>Hours*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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41234.1841" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
          <population>PK Population.</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Not applicable (NA) indicates data was not collected for this outcome measure as it was incorrectly stated as one of the Primary Endpoint in Objectives and Endpoints section of the Protocol, where the reference to parent analyte specifically for blood was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-inf) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-inf) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5532" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-inf) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-inf) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.0882" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-inf) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-inf) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19026.4818" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-inf) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-inf) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23226.8511" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as AUC(0-inf) is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as AUC(0-inf) is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</description>
          <population>PK population</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA indicates data was not collected for this outcome measure as AUC(0-inf) is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) in Plasma Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 mg (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) in Plasma Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40816.9451" spread="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
          <population>PK Population.</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA indicates data was not collected for this outcome measure as it was incorrectly stated as one of the Primary Endpoint in Objectives and Endpoints section of the Protocol, where the reference to parent analyte specifically for blood was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-t) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-t) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3371" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-t) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-t) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.8025" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC (0-t) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC (0-t) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18828.0326" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-t) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-t) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22746.1486" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at indicated time points for PK analysis.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at indicated time points for PK analysis.</description>
          <population>PK population</population>
          <units>Hours*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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2395.2833" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Concentration (Cmax) in Plasma Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 mg (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) in Plasma Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1293.0" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
          <population>PK 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA indicates data was not collected for this outcome measure as it was incorrectly stated as one of the Primary Endpoint in Objectives and Endpoints section of the Protocol, where the reference to parent analyte specifically for blood was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.435" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.462" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="628.2" spread="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="675.312" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at indicated time points for PK analysis.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at indicated time points for PK analysis.</description>
          <population>PK 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="377.5" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Occurrence of Cmax (Tmax) in Plasma Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 mg (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Occurrence of Cmax (Tmax) in Plasma Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</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="7.00" lower_limit="4.5" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
          <population>PK Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</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="NA" lower_limit="NA" upper_limit="NA">NA indicates data was not collected for this outcome measure as it was incorrectly stated as one of the Primary Endpoint in Objectives and Endpoints section of the Protocol, where the reference to parent analyte specifically for blood was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</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="0.983" lower_limit="0.983" upper_limit="0.983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</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="0.983" lower_limit="0.983" upper_limit="0.983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</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="4.00" lower_limit="1.5" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</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="4.0000" lower_limit="1.500" upper_limit="6.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at indicated time points for PK analysis.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at indicated time points for PK analysis.</description>
          <population>PK Population</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</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="6.0" lower_limit="2" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal Phase Half-life (T1/2) in Plasma Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 mg (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Phase Half-life (T1/2) in Plasma Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</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="24.0860" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</description>
          <population>PK Population.</population>
          <units>Hours</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="NA" spread="NA">NA indicates data was not collected for this outcome measure as it was incorrectly stated as one of the Primary Endpoint in Objectives and Endpoints section of the Protocol, where the reference to parent analyte specifically for blood was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</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="21.6959" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</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="29.7527" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</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="24.2493" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</population>
          <units>Hours</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="30.0505" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as T1/2 is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</description>
        <time_frame>Day 1: 2, 4, 6, 8, 10 hours</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as T1/2 is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</description>
          <population>PK Population</population>
          <units>Hours</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="NA" spread="NA">NA indicates data was not collected for this outcome measure as T1/2 is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Volume of Distribution at Steady State (Vss) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution at Steady State (Vss) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</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="28.7435" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clearance (CL) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance (CL) in Plasma Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</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="1.0357" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Renal Clearance (CLr) Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative amount [Ae][Urine] for Period 1)/(Plasma AUC[0-inf]).</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (CLr) Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative amount [Ae][Urine] for Period 1)/(Plasma AUC[0-inf]).</description>
          <population>PK Population</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="0.01992" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CLr Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative Ae[Urine] for Period 2)/(Plasma AUC[0-inf]).</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>CLr Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative Ae[Urine] for Period 2)/(Plasma AUC[0-inf]).</description>
          <population>PK Population</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="0.01465" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Oral Clearance (CL/F) in Plasma Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 mg (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Clearance (CL/F) in Plasma Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</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="4.8503" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CL/F in Plasma Following Administration Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>CL/F in Plasma Following Administration Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</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="4.4675" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Volume of Distribution (Vz/F) Following Administration of Oral Dose of GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet</title>
            <description>Eligible participants received a single oral dose of 200 mg (2×100 mg) tablets with a moderate fat meal on Day 1 in treatment Period 1</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vz/F) Following Administration of Oral Dose of GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</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="168.5433" spread="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vz/F Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Vz/F Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK Population</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="156.2909" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Oral Bioavailability of GSK3640254</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 Tablet)/Dose(Oral Tablet) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses were analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Oral Bioavailability of GSK3640254</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 Tablet)/Dose(Oral Tablet) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses were analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.</description>
          <population>PK Population</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC (0 to infinity)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2317" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC (0 to t)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2373" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Drug Escaping First Pass Hepatic Clearance (Fh) Following Administration of [14C]-GSK3640254 IV</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. Fh was expressed as percentage and was calculated as: 1 minus hepatic extraction ratio multiplied by 100. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute).</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Drug Escaping First Pass Hepatic Clearance (Fh) Following Administration of [14C]-GSK3640254 IV</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. Fh was expressed as percentage and was calculated as: 1 minus hepatic extraction ratio multiplied by 100. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute).</description>
          <population>PK Population</population>
          <units>Percentage of drug escaped</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="0.9945" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Drug Absorbed (Fa) Following Administration of [14C]-GSK3640254 Oral Suspension</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. Fa was expressed as percentage which was calculated as ratio of oral bioavailability and Fh multiplied by 100.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Drug Absorbed (Fa) Following Administration of [14C]-GSK3640254 Oral Suspension</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. Fa was expressed as percentage which was calculated as ratio of oral bioavailability and Fh multiplied by 100.</description>
          <population>PK Population</population>
          <units>Percentage of drug absorbed</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="0.2595" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Drug Escaping Gut Metabolism (Fg) Following Administration of [14C]-GSK3640254 Oral Suspension</title>
        <description>Blood samples were collected at the indicated time points for PK analysis. Fg is defined as the fraction metabolized by gut wall as a fraction of the oral dose and was expressed as 1 minus Metabolite load following intravenous and oral administration multiplied by 100.</description>
        <time_frame>Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Drug Escaping Gut Metabolism (Fg) Following Administration of [14C]-GSK3640254 Oral Suspension</title>
          <description>Blood samples were collected at the indicated time points for PK analysis. Fg is defined as the fraction metabolized by gut wall as a fraction of the oral dose and was expressed as 1 minus Metabolite load following intravenous and oral administration multiplied by 100.</description>
          <population>PK Population</population>
          <units>Percentage of drug escaped</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="0.8980" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Total Radioactive Dose Excreted in Urine Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100. Not applicable (NA) indicates that No concentration values detected for pre-dose.</description>
        <time_frame>Day 1 (Pre-dose), 5, 24, 48, 72, 96, 120, 144 and 163 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Total Radioactive Dose Excreted in Urine Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100. Not applicable (NA) indicates that No concentration values detected for pre-dose.</description>
          <population>PK Population</population>
          <units>Percentage of 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No concentration values detected for pre-dose.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.61" spread="0.514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="0.551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="0.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.84" spread="0.581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="0.585"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>163 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.86" spread="0.589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Total Radioactive Dose Excreted in Urine Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100.</description>
        <time_frame>Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Total Radioactive Dose Excreted in Urine Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100.</description>
          <population>PK Population</population>
          <units>Percentage of 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>168 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>192 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>216 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>240 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>264 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>288 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Total Radioactive Dose Excreted in Feces Following Administration of IV Dose of [14C]-GSK3640254</title>
        <description>Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100. NA indicates that No concentration values detected for pre-dose.</description>
        <time_frame>Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144 and 163 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 IV</title>
            <description>Eligible participants received an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in treatment Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Total Radioactive Dose Excreted in Feces Following Administration of IV Dose of [14C]-GSK3640254</title>
          <description>Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100. NA indicates that No concentration values detected for pre-dose.</description>
          <population>PK Population</population>
          <units>Percentage of 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No concentration values detected for pre-dose.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0855" spread="0.0690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="9.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.1" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.1" spread="5.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>163 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.6" spread="4.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Total Radioactive Dose Excreted in Feces Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100.</description>
        <time_frame>Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Total Radioactive Dose Excreted in Feces Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100.</description>
          <population>PK Population</population>
          <units>Percentage of 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8" spread="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.8" spread="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0" spread="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.9" spread="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.8" spread="42.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>168 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.9" spread="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>192 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" spread="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>216 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" spread="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>240 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" spread="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>264 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.7" spread="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>288 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.8" spread="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-serious 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 intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose 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 or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to [&gt;=]5 percent [%]) non-serious AEs and SAEs is presented.</description>
        <time_frame>Up to 50 days</time_frame>
        <population>Safety Population comprised of all participants who received at least one dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-serious 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 intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose 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 or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to [&gt;=]5 percent [%]) non-serious AEs and SAEs is presented.</description>
          <population>Safety Population comprised of all participants who received at least one dose of study intervention.</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="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Non-serious AEs</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>Any SAEs</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 Post Baseline Relative to Baseline</title>
        <description>Blood samples were collected to analyze following hematology parameters; Basophils, Eosinophils, Erythrocytes mean corpuscular hemoglobin (MCH), Erythrocytes mean corpuscular volume (MCV), Erythrocytes, Hematocrit (HCT), Hemoglobin (Hb), Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes and Reticulocytes/Erythrocytes. Participants were counted in worst case category if their value changed to (low, normal or high), unless there was no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.] High to High), or whose value became normal, were 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%. Baseline value=latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.</description>
        <time_frame>Baseline (Day 1: pre-dose) and Up to 50 Days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Hematology Results Relative to Normal Range Post Baseline Relative to Baseline</title>
          <description>Blood samples were collected to analyze following hematology parameters; Basophils, Eosinophils, Erythrocytes mean corpuscular hemoglobin (MCH), Erythrocytes mean corpuscular volume (MCV), Erythrocytes, Hematocrit (HCT), Hemoglobin (Hb), Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes and Reticulocytes/Erythrocytes. Participants were counted in worst case category if their value changed to (low, normal or high), unless there was no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.] High to High), or whose value became normal, were 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%. Baseline value=latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.</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="5"/>
                <count group_id="O2" value="5"/>
              </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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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>Erythrocytes 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>Erythrocytes MCH, 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>Erythrocytes 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>Erythrocytes 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>Erythrocytes MCV, 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>Erythrocytes 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="0"/>
                    <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="5"/>
                  </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="0"/>
                    <measurement group_id="O2" value="2"/>
                  </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="3"/>
                  </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="0"/>
                    <measurement group_id="O2" value="1"/>
                  </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="4"/>
                  </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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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="0"/>
                    <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="5"/>
                  </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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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="5"/>
                    <measurement group_id="O2" value="4"/>
                  </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="1"/>
                  </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="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes, To High</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>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="4"/>
                    <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="1"/>
                    <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 Post Baseline Relative to Baseline</title>
        <description>Blood samples were collected to analyze following clinical chemistry parameters:Alanine aminotransferase(ALT),albumin,alkaline phosphatase(ALP),aspartate aminotransferase(AST),bilirubin,calcium,chloride,cholesterol,creatinine,direct bilirubin,globulin,glucose,high-density lipoprotein (HDL) cholesterol,low-density lipoprotein (LDL) cholesterol,phosphate,potassium,protein,sodium,triglycerides,urate and urea.Participants were counted in worst case category if their value changed to(low,normal or high),unless there was no change in their category.Participants whose laboratory value category was unchanged(e.g. High to High),or whose value became normal,were 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%.Baseline value=latest pre-dose assessment(prior to oral dose) in each treatment period,with a non-missing value,including those from unscheduled visits</description>
        <time_frame>Baseline (Day 1: pre-dose) and Up to 50 Days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post Baseline Relative to Baseline</title>
          <description>Blood samples were collected to analyze following clinical chemistry parameters:Alanine aminotransferase(ALT),albumin,alkaline phosphatase(ALP),aspartate aminotransferase(AST),bilirubin,calcium,chloride,cholesterol,creatinine,direct bilirubin,globulin,glucose,high-density lipoprotein (HDL) cholesterol,low-density lipoprotein (LDL) cholesterol,phosphate,potassium,protein,sodium,triglycerides,urate and urea.Participants were counted in worst case category if their value changed to(low,normal or high),unless there was no change in their category.Participants whose laboratory value category was unchanged(e.g. High to High),or whose value became normal,were 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%.Baseline value=latest pre-dose assessment(prior to oral dose) in each treatment period,with a non-missing value,including those from unscheduled visits</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="5"/>
                <count group_id="O2" value="5"/>
              </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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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>Albumin, 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>Albumin, 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>Albumin, 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>ALP, 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>ALP, 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>ALP, 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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>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>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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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>Chloride, 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>Chloride, To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, To High</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>Cholesterol, 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>Cholesterol, 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>Cholesterol, 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="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, To High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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>Globulin, 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>Globulin, To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Globulin, 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>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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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>HDL Cholesterol, 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>HDL Cholesterol, 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>HDL Cholesterol, 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>LDL Cholesterol, 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>LDL Cholesterol, To Normal or No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Cholesterol, To High</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>Phosphate, 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>Phosphate, 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>Phosphate, 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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, To High</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 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>Sodium, 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>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>Triglycerides, 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>Triglycerides, 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>Triglycerides, 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>Urate, 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>Urate, 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>Urate, 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="5"/>
                    <measurement group_id="O2" value="5"/>
                  </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 Clinically Significant Urinalysis Findings</title>
        <description>Urine samples were collected to detect the presence of bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, protein and urobilinogen. Urinalysis also included measurement of specific gravity and potential of Hydrogen (pH). Number of participants with clinically significant urinalysis findings are presented.</description>
        <time_frame>Up to 50 days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Urinalysis Findings</title>
          <description>Urine samples were collected to detect the presence of bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, protein and urobilinogen. Urinalysis also included measurement of specific gravity and potential of Hydrogen (pH). Number of participants with clinically significant urinalysis findings are 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="5"/>
                <count group_id="O2" value="5"/>
              </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 Worst Case Post Baseline Abnormal 12-Lead Electrocardiogram (ECG) Findings</title>
        <description>12-lead ECGs were recorded with the participants in semi-supine position after 5 minutes rest using an automated ECG machine that measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal, not clinically significant (NCS) and Clinically significant (CS) ECG findings for worst case post-Baseline are presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.</description>
        <time_frame>Baseline (Day 1: pre-dose) and Up to 50 days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Post Baseline Abnormal 12-Lead Electrocardiogram (ECG) Findings</title>
          <description>12-lead ECGs were recorded with the participants in semi-supine position after 5 minutes rest using an automated ECG machine that measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal, not clinically significant (NCS) and Clinically significant (CS) ECG findings for worst case post-Baseline are presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.</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="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abnormal, NCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal, CS</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>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
        <description>SBP and DBP were measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)</title>
          <description>SBP and DBP were measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
          <units>Millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP: Day 1 (4 hours); n= 5, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="6.95"/>
                    <measurement group_id="O2" value="-0.3" spread="5.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Day 1 (4 hours); n = 5, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="6.19"/>
                    <measurement group_id="O2" value="3.0" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP: Day 8; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="5.07"/>
                    <measurement group_id="O2" value="3.0" spread="6.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP: Day 8; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="6.30"/>
                    <measurement group_id="O2" value="-5.8" spread="6.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pulse Rate</title>
        <description>Pulse rate was measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pulse Rate</title>
          <description>Pulse rate was measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in 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="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pulse rate: Day 1 (4 hours); n= 5, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="7.53"/>
                    <measurement group_id="O2" value="-2.3" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate: Day 8; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="7.19"/>
                    <measurement group_id="O2" value="0.0" spread="5.29"/>
                  </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 semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Rate</title>
          <description>Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in 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="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Respiratory rate: Day 1 (4 hours); n= 5, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="2.83"/>
                    <measurement group_id="O2" value="-1.0" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory rate: Day 8; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.79"/>
                    <measurement group_id="O2" value="0.8" spread="1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Temperature</title>
        <description>Temperature was measured in semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: pre-dose), Day 1 (4 hours), 36, 72, 96, 120, 144, 168 hours and Day 8</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Temperature</title>
          <description>Temperature was measured in semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).</population>
          <units>Degree 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="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Temperature: 4 hours; n= 5, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.259"/>
                    <measurement group_id="O2" value="0.38" spread="0.403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: 36 hours; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.404"/>
                    <measurement group_id="O2" value="0.28" spread="0.383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: 72 hours; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.336"/>
                    <measurement group_id="O2" value="0.32" spread="0.415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: 96 hours; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="0.421"/>
                    <measurement group_id="O2" value="0.08" spread="0.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: 120 hours; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="0.321"/>
                    <measurement group_id="O2" value="-0.14" spread="0.329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: 144 hours; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.356"/>
                    <measurement group_id="O2" value="0.00" spread="0.430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: 168 hours; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.277"/>
                    <measurement group_id="O2" value="0.08" spread="0.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature: Day 8; n= 5, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.36" spread="0.385"/>
                    <measurement group_id="O2" value="0.16" spread="0.270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Weight</title>
        <description>Weight was measured and recorded. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
        <time_frame>Baseline (Day 1: pre-dose) and up to Day 8</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3640254 Tablet + [14C]-GSK3640254 IV</title>
            <description>Eligible participants were administered a single oral dose of GSK3640254 200 mg (2×100 mg) tablets with a moderate fat meal, followed by an IV infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Weight</title>
          <description>Weight was measured and recorded. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.</description>
          <population>Safety Population</population>
          <units>Kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.64" spread="0.792"/>
                    <measurement group_id="O2" value="-1.10" spread="0.892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Radioactivity in Blood to Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
        <description>Blood samples were collected at the indicated time points for analysis of total radioactivity in blood to plasma. It was calculated as Radioactivity Concentration in blood (Cb) divided by Radioactivity Concentration in plasma (Cp).</description>
        <time_frame>Day 1: 2, 4, 6, 8 and 10 hours</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-GSK3640254 Oral Suspension</title>
            <description>Eligible participants received a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal on Day 1 in treatment period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Radioactivity in Blood to Plasma Following Administration of Oral Dose of [14C]-GSK3640254</title>
          <description>Blood samples were collected at the indicated time points for analysis of total radioactivity in blood to plasma. It was calculated as Radioactivity Concentration in blood (Cb) divided by Radioactivity Concentration in plasma (Cp).</description>
          <population>PK Population</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</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>
              <title>2 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.555" spread="0.0340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.480" spread="0.0844"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.522" spread="0.0429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.503" spread="0.0249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.595" spread="0.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality, SAEs and non-serious AEs were collected from the start of study treatment up to Day 50.</time_frame>
      <desc>SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>GSK3640254 Tablet+[14C]-GSK3640254 IV</title>
          <description>Participants were administered a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal, followed by an intravenous (IV) infusion of [14C]-GSK3640254 100 micrograms for 1 hour on Day 1 in Treatment Period 1. The treatment periods were separated by a washout period of at least 13 days between oral doses.</description>
        </group>
        <group group_id="E2">
          <title>[14C]-GSK3640254 Oral Suspension</title>
          <description>Participants were administered a single oral dose of 85 mg [14C]-GSK3640254 as an oral suspension with a moderate fat meal in Treatment Period 2 on Day 1. The treatment periods were separated by a washout period of at least 13 days between oral doses.</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</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="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </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>ViiV Healthcare</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/NCT04507321
org study id: 213051
secondary id: 2019-004444-30
nct id: NCT04507321
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is an open-label, single-center, single group, non-randomized, two-period, single
      sequence, mass balance study which will enroll 6 healthy male participants. This study will
      assess the pharmacokinetics, balance/excretion, and metabolism of GSK3640254 in humans using
      [14C]-radiolabeled drug substance administered as an intravenous (IV) infusion and via the
      oral route. The study will also provide an assessment of GSK3640254 absorption, metabolism
      and excretion following administration of a [14C]-radiolabeled oral suspension. Each
      participant will be involved in the study for up to 10 weeks which will include a screening
      period, two treatment periods (treatment Periods 1 and 2) separated by a washout of at least
      13 days between oral doses, and a follow-up visit 7-14 days after the last assessment in
      treatment Period 2.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will receive non-radiolabeled GSK3640254 oral tablets concomitantly with radiolabeled [14C]-GSK3640254 administered as an IV infusion in treatment Period 1 and radiolabeled [14C]-GSK3640254 as an oral suspension in treatment Period 2.
primary purpose: Treatment
masking: None (Open Label)
masking description: This will be an open-label study.
measure: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) in Plasma Following Administration of Oral Dose of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for Pharmacokinetic (PK) analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.
measure: AUC(0-inf) in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-inf) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-inf) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-inf) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-inf) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as AUC(0-inf) is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.
measure: AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) in Plasma Following Administration of Oral Dose of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.
measure: AUC(0-t) in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-t) of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC (0-t) in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-t) of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: AUC(0-t) of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points for PK analysis.
measure: Maximum Observed Concentration (Cmax) in Plasma Following Administration of Oral Dose of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.
measure: Cmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Cmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Cmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Cmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Cmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points for PK analysis.
measure: Time of Occurrence of Cmax (Tmax) in Plasma Following Administration of Oral Dose of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.
measure: Tmax in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Tmax of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Tmax in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Tmax of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Tmax of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points for PK analysis.
measure: Terminal Phase Half-life (T1/2) in Plasma Following Administration of Oral Dose of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points. Data was not collected because a discrepancy has been identified in the Objectives and Endpoints section of the Protocol, which incorrectly states one of the Primary Endpoints. The Objectives and Endpoints section incorrectly states that the PK parameters of both the parent and total drug-related material (radioactivity) in plasma and blood would be presented. Neither the Schedule of Activities nor the Study Assessments and Procedures sections of the Protocol address the sampling and measurement of concentrations of parent drug in blood or calculation of derived PK parameters. Consequently, no parent analyte measurements were performed for blood samples. Thus, the reference to parent analyte specifically for blood, in the Objectives and Endpoints section was an error. Only samples and measurements for total drug-related material (radioactivity) in blood and plasma, and parent drug in plasma were collected to derive PK parameters.
measure: T1/2 in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: T1/2 of Total Radioactivity in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: T1/2 in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: T1/2 of Total Radioactivity in Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: T1/2 of Total Radioactivity in Blood Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1: 2, 4, 6, 8, 10 hours
description: Blood samples were collected at indicated time points for PK analysis. Data was not collected for this Outcome measure as T1/2 is not calculable for total radioactivity in blood due to insufficient sampling in the terminal phase.
measure: Volume of Distribution at Steady State (Vss) in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Clearance (CL) in Plasma Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Renal Clearance (CLr) Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative amount [Ae][Urine] for Period 1)/(Plasma AUC[0-inf]).
measure: CLr Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. Renal clearance was calculated as (Cumulative Ae[Urine] for Period 2)/(Plasma AUC[0-inf]).
measure: Oral Clearance (CL/F) in Plasma Following Administration of Oral Dose of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: CL/F in Plasma Following Administration Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Apparent Volume of Distribution (Vz/F) Following Administration of Oral Dose of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Vz/F Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
measure: Absolute Oral Bioavailability of GSK3640254
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
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 Tablet)/Dose(Oral Tablet) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses were analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.
measure: Percentage of Drug Escaping First Pass Hepatic Clearance (Fh) Following Administration of [14C]-GSK3640254 IV
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.25, 5.5, 6, 7, 8, 9, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. Fh was expressed as percentage and was calculated as: 1 minus hepatic extraction ratio multiplied by 100. Hepatic extraction ratio=hepatic blood clearance (milliliters per minute)/hepatic blood flow (milliliters per minute).
measure: Percentage of Drug Absorbed (Fa) Following Administration of [14C]-GSK3640254 Oral Suspension
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. Fa was expressed as percentage which was calculated as ratio of oral bioavailability and Fh multiplied by 100.
measure: Percentage of Drug Escaping Gut Metabolism (Fg) Following Administration of [14C]-GSK3640254 Oral Suspension
time frame: Day 1 (Pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
description: Blood samples were collected at the indicated time points for PK analysis. Fg is defined as the fraction metabolized by gut wall as a fraction of the oral dose and was expressed as 1 minus Metabolite load following intravenous and oral administration multiplied by 100.
measure: Percentage of Total Radioactive Dose Excreted in Urine Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 5, 24, 48, 72, 96, 120, 144 and 163 hours post-dose
description: Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100. Not applicable (NA) indicates that No concentration values detected for pre-dose.
measure: Percentage of Total Radioactive Dose Excreted in Urine Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
description: Urine samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in urine. Percentage of radioactive dose excreted in urine was calculated as (amount excreted in urine divided by administered radioactivity dose) multiplied by 100.
measure: Percentage of Total Radioactive Dose Excreted in Feces Following Administration of IV Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144 and 163 hours post-dose
description: Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100. NA indicates that No concentration values detected for pre-dose.
measure: Percentage of Total Radioactive Dose Excreted in Feces Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1 (Pre-dose), 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose
description: Fecal samples were collected at indicated timepoints to measure percentage of the total radioactive drug-related material excreted in feces. Percentage of radioactive dose excreted was calculated as (amount excreted in feces homogenate divided by administered radioactivity dose) multiplied by 100.
measure: Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)
time frame: Up to 50 days
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose 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 or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to [>=]5 percent [%]) non-serious AEs and SAEs is presented.
measure: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post Baseline Relative to Baseline
time frame: Baseline (Day 1: pre-dose) and Up to 50 Days
description: Blood samples were collected to analyze following hematology parameters; Basophils, Eosinophils, Erythrocytes mean corpuscular hemoglobin (MCH), Erythrocytes mean corpuscular volume (MCV), Erythrocytes, Hematocrit (HCT), Hemoglobin (Hb), Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes and Reticulocytes/Erythrocytes. Participants were counted in worst case category if their value changed to (low, normal or high), unless there was no change in their category. Participants whose laboratory value category was unchanged (for example [e.g.] High to High), or whose value became normal, were 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%. Baseline value=latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.
measure: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post Baseline Relative to Baseline
time frame: Baseline (Day 1: pre-dose) and Up to 50 Days
description: Blood samples were collected to analyze following clinical chemistry parameters:Alanine aminotransferase(ALT),albumin,alkaline phosphatase(ALP),aspartate aminotransferase(AST),bilirubin,calcium,chloride,cholesterol,creatinine,direct bilirubin,globulin,glucose,high-density lipoprotein (HDL) cholesterol,low-density lipoprotein (LDL) cholesterol,phosphate,potassium,protein,sodium,triglycerides,urate and urea.Participants were counted in worst case category if their value changed to(low,normal or high),unless there was no change in their category.Participants whose laboratory value category was unchanged(e.g. High to High),or whose value became normal,were 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%.Baseline value=latest pre-dose assessment(prior to oral dose) in each treatment period,with a non-missing value,including those from unscheduled visits
measure: Number of Participants With Clinically Significant Urinalysis Findings
time frame: Up to 50 days
description: Urine samples were collected to detect the presence of bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, protein and urobilinogen. Urinalysis also included measurement of specific gravity and potential of Hydrogen (pH). Number of participants with clinically significant urinalysis findings are presented.
measure: Number of Participants With Worst Case Post Baseline Abnormal 12-Lead Electrocardiogram (ECG) Findings
time frame: Baseline (Day 1: pre-dose) and Up to 50 days
description: 12-lead ECGs were recorded with the participants in semi-supine position after 5 minutes rest using an automated ECG machine that measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal, not clinically significant (NCS) and Clinically significant (CS) ECG findings for worst case post-Baseline are presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits.
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
time frame: Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8
description: SBP and DBP were measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Change From Baseline in Pulse Rate
time frame: Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8
description: Pulse rate was measured in semi-supine position after 5 minutes rest with a completely automated device. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Change From Baseline in Respiratory Rate
time frame: Baseline (Day 1: pre-dose), Day 1 (4 hours) and Day 8
description: Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Change From Baseline in Temperature
time frame: Baseline (Day 1: pre-dose), Day 1 (4 hours), 36, 72, 96, 120, 144, 168 hours and Day 8
description: Temperature was measured in semi-supine position after 5 minutes rest. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Change From Baseline in Weight
time frame: Baseline (Day 1: pre-dose) and up to Day 8
description: Weight was measured and recorded. Baseline value is defined as the latest pre-dose assessment (prior to the oral dose) in each treatment period, with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
measure: Total Radioactivity in Blood to Plasma Following Administration of Oral Dose of [14C]-GSK3640254
time frame: Day 1: 2, 4, 6, 8 and 10 hours
description: Blood samples were collected at the indicated time points for analysis of total radioactivity in blood to plasma. It was calculated as Radioactivity Concentration in blood (Cb) divided by Radioactivity Concentration in plasma (Cp).
arm group label: GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension
arm group type: Experimental
description: Participants will receive a single oral dose of GSK3640254 200 milligram (mg) (2×100 mg) tablets with a moderate fat meal. Participants will then be administered a 100 microgram (mcg) dose (approximately 3.7 kilobecquerel; 100 nano Curie) of [14C]-GSK3640254 as an IV infusion for 1 hour on Day 1 in treatment Period 1, On Day 1 in treatment Period 2, participants will receive a single oral dose of 85 mg (approximately 3.15 megabecquerel; 85 micro Curie) [14C]-GSK3640254 administered as an oral suspension with a moderate fat meal. A wash out period of at least 13 days will be maintained between oral doses of treatment periods.
intervention type: Drug
intervention name: GSK3640254 Oral tablet
description: GSK3640254 will be available as white film-coated round tablets to be administered via oral route with meal in the morning with 240 milliliter (mL) of water at room temperature.
arm group label: GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension
intervention type: Drug
intervention name: [14C]-GSK3640254 intravenous infusion
description: [14C]-GSK3640254 will be available as clear, colorless solution free from visible particulates to be administered via the IV route.
arm group label: GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension
intervention type: Drug
intervention name: [14C]-GSK3640254 powder
description: [14C]-GSK3640254 will be available as white powder to be reconstituted into a suspension with 25 mL of vehicle before dosing so as to administer 85 mg dose with meal in the morning.
arm group label: GSK3640254 tablet + [14C]-GSK3640254 IV/[14C] oral suspension
criteria: 
gender: Male
gender based: Yes
gender description: Male participants will be part of this study.
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: ViiV Healthcare
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 