<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/NCT03000686</url>
  </required_header>
  <id_info>
    <org_study_id>204987</org_study_id>
    <secondary_id>2016-002465-55</secondary_id>
    <nct_id>NCT03000686</nct_id>
  </id_info>
  <brief_title>Study of GSK2586881 on Acute Hypoxia and Exercise</brief_title>
  <official_title>The Effects of GSK2586881 on the Responses to Acute Hypoxia and Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted to examine how GSK2586881, a recombinant human ACE2 peptide,&#xD;
      modulates the acute hypoxic pulmonary vasoconstriction (HPV) response in healthy volunteers.&#xD;
      The study will be single-center, randomized, placebo-controlled and double blind (sponsor&#xD;
      open). Subjects will be randomized to receive a single intravenous (IV) dose of GSK2586881 or&#xD;
      placebo (saline) in a crossover design. The primary objective of the study is to evaluate the&#xD;
      effect of a single IV dose of GSK2586881 on the HPV response in healthy volunteers during&#xD;
      exercise under hypoxic conditions. Approximately 35 subjects will be enrolled for a maximum&#xD;
      of 56 days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated for technical feasibility, operational considerations and futility in line&#xD;
    with pre-specified criteria.&#xD;
  </why_stopped>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">January 4, 2019</completion_date>
  <primary_completion_date type="Actual">January 4, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline of Pulmonary Artery Systolic Pressure (PASP) Measured Via Echocardiography-Part 1</measure>
    <time_frame>Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Echocardiograms (Echo) were obtained at indicated time points with the participant resting supine or lying on their left side. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying the modified Bernoulli equation to convert this value into pressure values. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline of PASP Measured Via Echocardiography-Part 2</measure>
    <time_frame>Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Echocardiograms were obtained with participant resting supine or lying on their left side. Echo during exercise challenge was conducted with participant on a semi-recumbent cycle ergometer tilted by 30 to 40 degrees. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying modified Bernoulli equation to convert this value into pressure values. Change from Baseline is the post-dose visit value minus Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of the two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Renin-angiotensin System (RAS) Peptides-Part 1</measure>
    <time_frame>Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected to analyze RAS peptide biomarkers such as angiotensin II (Ang II), Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in RAS Peptides-Part 2</measure>
    <time_frame>Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected to analyze RAS peptides such as Ang II, Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1</measure>
    <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
    <description>SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SBP and DBP-Part 2</measure>
    <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
    <description>SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heart Rate-Part 1</measure>
    <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
    <description>Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heart Rate-Part 2</measure>
    <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
    <description>Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Oxygen Saturation-Part 1</measure>
    <time_frame>Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Oxygen Saturation-Part 2</measure>
    <time_frame>Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start, 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part 1</measure>
    <time_frame>pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period</time_frame>
    <description>Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal ECG Findings-Part 2</measure>
    <time_frame>pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period</time_frame>
    <description>Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTc intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AEs and SAEs-Part 2</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Immunogenicity Results-Part 1</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-angiotensin converting enzyme 2 (ACE2) binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Immunogenicity Results-Part 2</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Hematology Parameters-Part 1</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Blood samples were collected to analyze the following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Hematology Parameters-Part 2</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Blood samples were collected to analyze the following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Clinical Chemistry Parameters-Part 1</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Blood samples were collected to analyze the following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Clinical Chemistry Parameters-Part 2</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Blood samples were collected to analyze the following clinical chemistry parameters: BUN, creatinine, glucose, potassium, sodium, calcium, AST, ALT, alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Urine Parameters-Part 1</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Urine samples were collected to analyze the following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Urine Parameters-Part 2</measure>
    <time_frame>Up to 26 days</time_frame>
    <description>Urine samples were collected to analyze the following urine parameters: specific gravity, pH, glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of GSK2586881-Part 1</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2586881. Pharmacokinetic Part1 (PK1) Population comprised of participants in the mITT population, randomized in Part 1 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of GSK2586881-Part 2</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. Pharmacokinetic Part2 (PK2) Population comprised of participants in the mITT population, randomized in Part 2 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 1</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 2</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 1</measure>
    <time_frame>immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 2</measure>
    <time_frame>immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Concentration (Cmax) of GSK2586881-Part 1</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of GSK2586881-Part 2</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Cmax (Tmax) of GSK2586881-Part 1</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of GSK2586881-Part 2</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Half-life (T1/2) of GSK2586881-Part 1</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2 of GSK2586881-Part 2</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance for GSK2586881-Part 1</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance for GSK2586881-Part 2</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution for GSK2586881-Part 1</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution for GSK2586881-Part 2</measure>
    <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
    <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Treatment sequence AB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive GSK2586881 in period 1 and saline placebo in period 2. There will be a washout period of 3-14 days between two treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment sequence BA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive saline placebo in period 1 and GSK2586881 in period 2. There will be a washout period of 3-14 days between two treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GSK2586881</intervention_name>
    <description>GSK2586881 will be a clear colorless liquid for IV infusion over 3- 5 mins and will be administered as unit dose 0.8 mg/kg.</description>
    <arm_group_label>Treatment sequence AB</arm_group_label>
    <arm_group_label>Treatment sequence BA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline (0.9%) will be administered as a single IV dose infusion over 3 to 5 min.</description>
    <arm_group_label>Treatment sequence AB</arm_group_label>
    <arm_group_label>Treatment sequence BA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18 and 40 years of age inclusive, at the time of signing the informed consent.&#xD;
&#xD;
          -  Healthy as determined by the investigator or medically qualified designee based on a&#xD;
             medical evaluation including medical history, physical examination, laboratory tests&#xD;
             and cardiac monitoring. A subject with a clinical abnormality or laboratory&#xD;
             parameter(s) which is/are not specifically listed in the inclusion or exclusion&#xD;
             criteria, outside the reference range for the population being studied may be included&#xD;
             only if the investigator [in consultation with the Medical Monitor if required] agree&#xD;
             and document that the finding is unlikely to introduce additional risk factors and&#xD;
             will not interfere with the study procedures. Note: Screened subjects with laboratory&#xD;
             values outside of the normal range may be repeated once for inclusion into the study&#xD;
             at the discretion of the Investigator.&#xD;
&#xD;
          -  Screening echocardiogram of good quality, without clinically significant&#xD;
             abnormalities, and with mild-moderate tricuspid regurgitation sufficient for the&#xD;
             reliable estimation of PASP, as determined by the echocardiography core laboratory or&#xD;
             responsible cardiologist. Screening PASP within the normal range according to site&#xD;
             standards.&#xD;
&#xD;
          -  Subjects have not resided at an altitude &gt;1500 meter (m) for more than 7 days in the&#xD;
             last 4 month&#xD;
&#xD;
          -  Able to complete all study procedures.&#xD;
&#xD;
          -  Any contraindication (orthopedic, cardiac etc.) to perform exercise on a bicycle&#xD;
             ergometer.&#xD;
&#xD;
          -  Body weight 50 to 100 kilogram (kg) (inclusive).&#xD;
&#xD;
          -  Male or female (non Child Bearing Potential): Male subjects with female partners of&#xD;
             child bearing potential must comply with the following contraception requirements from&#xD;
             the time of first dose of study medication until at least five half-lives of study&#xD;
             medication OR for a cycle of spermatogenesis following five terminal half-lives after&#xD;
             the last dose of study medication. a. Vasectomy with documentation of azoospermia. b.&#xD;
             Male condom plus partner use of one of the contraceptive options (Contraceptive&#xD;
             subdermal implant, Intrauterine device or intrauterine system, Oral Contraceptive-&#xD;
             either combined or progestogen alone, Injectable progestogen, Contraceptive vaginal&#xD;
             ring, Percutaneous contraceptive patches). This is an all-inclusive list of those&#xD;
             methods that meet the following GSK definition of highly effective: having a failure&#xD;
             rate of less than 1% per year when used consistently and correctly and, when&#xD;
             applicable, in accordance with the product label. For non-product methods (e.g., male&#xD;
             sterility), the investigator determines what is consistent and correct use. The GSK&#xD;
             definition is based on the definition provided by the International Conference on&#xD;
             Harmonization (ICH).The investigator is responsible for ensuring that subjects&#xD;
             understand how to properly use these methods of contraception. A female subject is&#xD;
             eligible to participate if she is not pregnant (as confirmed by a negative urine human&#xD;
             chorionic gonadotrophin [hCG] test), not lactating, and the following condition&#xD;
             applies: Non-reproductive potential defined as, 1. Pre-menopausal females with one of&#xD;
             the following (Documented tubal ligation, Documented hysteroscopic tubal occlusion&#xD;
             procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy,&#xD;
             Documented Bilateral Oophorectomy). 2. Postmenopausal defined as 12 months of&#xD;
             spontaneous amenorrhea [in questionable cases a blood sample with simultaneous&#xD;
             follicle stimulating hormone (FSH) and estradiol levels consistent with menopause&#xD;
             (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone&#xD;
             replacement therapy (HRT) and whose menopausal status is in doubt will be required to&#xD;
             use one of the highly effective contraception methods if they wish to continue their&#xD;
             HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of&#xD;
             post-menopausal status prior to study enrolment. The investigator is responsible for&#xD;
             ensuring that subjects understand how to properly use these methods of contraception.&#xD;
&#xD;
          -  Capable of giving signed informed consent as described in study protocol which&#xD;
             includes compliance with the requirements and restrictions listed in the consent form&#xD;
             and in the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ALT &gt;1.5x Upper limit of normal (ULN).&#xD;
&#xD;
          -  Bilirubin &gt;1.5xULN (isolated bilirubin &gt;1.5xULN is acceptable if bilirubin is&#xD;
             fractionated and direct bilirubin &lt;35%).&#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).&#xD;
&#xD;
          -  QTc &gt; 450 millisecond (msec.)&#xD;
&#xD;
          -  Unable to refrain from prescription or non-prescription drugs, including agents active&#xD;
             in the central nervous system, vitamins, herbal and dietary supplements (including St&#xD;
             John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5&#xD;
             half-lives (whichever is longer) prior to the first dose of study medication and&#xD;
             throughout the study, unless in the opinion of the Investigator and/or GSK Medical&#xD;
             Monitor (if needed) the medication will not interfere with the study procedures or&#xD;
             compromise subject safety.&#xD;
&#xD;
          -  History of regular alcohol consumption within 6 months of the study defined as: An&#xD;
             average weekly intake of &gt;21 units for males or &gt;14 units for females. One unit is&#xD;
             equivalent to 8 gram (g) of alcohol: a half-pint (approximately 240 milliliter [ml])&#xD;
             of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.&#xD;
&#xD;
          -  Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or&#xD;
             nicotine-containing products within 6 months prior to screening&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof or a&#xD;
             history of drug or other allergy that, in the opinion of the investigator or Medical&#xD;
             Monitor, contraindicates their participation.&#xD;
&#xD;
          -  Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test&#xD;
             result at screening or within 3 months prior to first dose of study treatment. For&#xD;
             potent immunosuppressive agents, subjects with presence of hepatitis B core antibody&#xD;
             (HBcAb) should also be excluded.&#xD;
&#xD;
          -  A positive pre-study drug/alcohol screen.&#xD;
&#xD;
          -  A positive test for Human Immunodeficiency Virus (HIV) antibody.&#xD;
&#xD;
          -  Where participation in the study would result in donation of blood or blood products&#xD;
             in excess of 500 ml within 56 days.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 30 days, 5 half-lives or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer).&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to the first&#xD;
             dosing day.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <results_first_submitted>December 3, 2019</results_first_submitted>
  <results_first_submitted_qc>December 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2019</results_first_posted>
  <last_update_submitted>December 3, 2019</last_update_submitted>
  <last_update_submitted_qc>December 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GSK2586881, Acute hypoxia, Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03000686/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>June 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03000686/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Healthy participants who met the eligibility criteria entered a 2-period crossover study. Participants were randomized to either placebo or GSK2586881 in each Treatment Period. Total duration of participation was 8 weeks. Study was terminated for technical feasibility, operational considerations and futility in line with pre-specified criteria.</recruitment_details>
      <pre_assignment_details>A total of 48 participants were screened, of which 31 failed screening and 17 (11 participants in Part 1 and 6 in Part 2) were enrolled in the study. The study was conducted at a single center in Germany.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: Placebo/GSK2586881</title>
          <description>Participants were administered a single intravenous (IV) dose of placebo in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of 0.8 milligrams per kilogram (mg/kg) GSK2586881. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum oxygen consumption (VO2) uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: GSK2586881/Placebo</title>
          <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of placebo. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
        </group>
        <group group_id="P3">
          <title>Part 2: Placebo/GSK2586881</title>
          <description>Participants were administered a single IV dose of placebo in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of 0.8 mg/kg GSK2586881. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
        </group>
        <group group_id="P4">
          <title>Part 2: GSK2586881/Placebo</title>
          <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in treatment period 1 followed by a washout of period of up to 14 days. In treatment period 2, participants were administered a single IV dose of placebo. During each period, approximately 30 minutes after administration of study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1, Period 1 (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 1, Wash-out (Up to 14 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 1, Period 2 (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 2, Period 1 (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 2, Wash-out (Up to 14 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 2, Period 2 (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants-Part 1</title>
          <description>All participants who were randomized to either of the two treatment sequences Placebo/GSK2586881 or GSK2586881/Placebo and received a single IV dose of GSK2586881 and placebo in either Treatment period 1 or 2 during Part 1 of the study were included. The treatment periods were separated by a wash-out period of 3 to 14 days.</description>
        </group>
        <group group_id="B2">
          <title>All Participants-Part 2</title>
          <description>All participants who were randomized to either of the two treatment sequences Placebo/GSK2586881 or GSK2586881/Placebo and received a single IV dose of GSK2586881 and placebo in either Treatment period 1 or 2 during Part 2 of the study were included. The treatment periods were separated by a wash-out period of 3 to 14 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="17"/>
          </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="26.2" spread="4.24"/>
                    <measurement group_id="B2" value="29.2" spread="6.21"/>
                    <measurement group_id="B3" value="27.2" spread="5.04"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White - White/Caucasian/European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline of Pulmonary Artery Systolic Pressure (PASP) Measured Via Echocardiography-Part 1</title>
        <description>Echocardiograms (Echo) were obtained at indicated time points with the participant resting supine or lying on their left side. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying the modified Bernoulli equation to convert this value into pressure values. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.</description>
        <time_frame>Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>Modified Intent-To-Treat Part 1 (mITT1) Population comprised of all participants randomized to Part 1 of the study (planned 4000 meter altitude), excluding those randomized in error. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of Pulmonary Artery Systolic Pressure (PASP) Measured Via Echocardiography-Part 1</title>
          <description>Echocardiograms (Echo) were obtained at indicated time points with the participant resting supine or lying on their left side. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying the modified Bernoulli equation to convert this value into pressure values. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.</description>
          <population>Modified Intent-To-Treat Part 1 (mITT1) Population comprised of all participants randomized to Part 1 of the study (planned 4000 meter altitude), excluding those randomized in error. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Millimeters of mercury</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes post-infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.715" lower_limit="-3.626" upper_limit="2.122"/>
                    <measurement group_id="O2" value="-0.695" lower_limit="-3.610" upper_limit="2.153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber entry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.299" lower_limit="-0.052" upper_limit="8.633"/>
                    <measurement group_id="O2" value="0.275" lower_limit="-4.044" upper_limit="4.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.619" lower_limit="-5.122" upper_limit="8.349"/>
                    <measurement group_id="O2" value="-0.046" lower_limit="-6.752" upper_limit="6.635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-chamber exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.189" lower_limit="-3.590" upper_limit="3.097"/>
                    <measurement group_id="O2" value="-1.026" lower_limit="-4.393" upper_limit="2.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>0.021</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.1339</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.249</ci_lower_limit>
            <ci_upper_limit>2.295</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-4.021</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.5923</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.168</ci_lower_limit>
            <ci_upper_limit>1.146</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-1.668</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>4.4927</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.576</ci_lower_limit>
            <ci_upper_limit>7.231</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.824</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.6695</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.142</ci_lower_limit>
            <ci_upper_limit>2.506</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline of PASP Measured Via Echocardiography-Part 2</title>
        <description>Echocardiograms were obtained with participant resting supine or lying on their left side. Echo during exercise challenge was conducted with participant on a semi-recumbent cycle ergometer tilted by 30 to 40 degrees. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying modified Bernoulli equation to convert this value into pressure values. Change from Baseline is the post-dose visit value minus Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of the two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.</description>
        <time_frame>Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT Part 2 (mITT2) Population comprised of all participants randomized to Part 2 of the study (planned 5000 meter altitude), excluding those randomized in error. Only those participants with data available at the specified time point were analyzed (represented by n=X, X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of PASP Measured Via Echocardiography-Part 2</title>
          <description>Echocardiograms were obtained with participant resting supine or lying on their left side. Echo during exercise challenge was conducted with participant on a semi-recumbent cycle ergometer tilted by 30 to 40 degrees. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying modified Bernoulli equation to convert this value into pressure values. Change from Baseline is the post-dose visit value minus Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of the two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.</description>
          <population>mITT Part 2 (mITT2) Population comprised of all participants randomized to Part 2 of the study (planned 5000 meter altitude), excluding those randomized in error. Only those participants with data available at the specified time point were analyzed (represented by n=X, X in category titles).</population>
          <units>Millimeters of mercury</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes post-infusion; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.756" lower_limit="-0.393" upper_limit="5.847"/>
                    <measurement group_id="O2" value="2.093" lower_limit="-1.009" upper_limit="5.246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber entry; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.399" lower_limit="4.572" upper_limit="14.234"/>
                    <measurement group_id="O2" value="6.599" lower_limit="1.697" upper_limit="11.439"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 minutes post-exercise start; n=6, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.665" lower_limit="8.972" upper_limit="20.406"/>
                    <measurement group_id="O2" value="14.646" lower_limit="8.517" upper_limit="20.455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-chamber exit; n=6, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.156" lower_limit="0.904" upper_limit="7.468"/>
                    <measurement group_id="O2" value="3.867" lower_limit="0.592" upper_limit="7.174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.662</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.1933</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.037</ci_lower_limit>
            <ci_upper_limit>3.815</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-2.796</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>3.4297</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.729</ci_lower_limit>
            <ci_upper_limit>4.027</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.018</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>4.1450</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.475</ci_lower_limit>
            <ci_upper_limit>8.086</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.291</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.3277</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.960</ci_lower_limit>
            <ci_upper_limit>4.386</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Renin-angiotensin System (RAS) Peptides-Part 1</title>
        <description>Blood samples were collected to analyze RAS peptide biomarkers such as angiotensin II (Ang II), Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.</description>
        <time_frame>Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Renin-angiotensin System (RAS) Peptides-Part 1</title>
          <description>Blood samples were collected to analyze RAS peptide biomarkers such as angiotensin II (Ang II), Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.</description>
          <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).</population>
          <units>Picograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ang II, End of infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.551" lower_limit="0.289" upper_limit="1.051"/>
                    <measurement group_id="O2" value="0.278" lower_limit="0.149" upper_limit="0.522"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 15 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.649" lower_limit="0.392" upper_limit="1.073"/>
                    <measurement group_id="O2" value="0.305" lower_limit="0.155" upper_limit="0.602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 15 to 45 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.661" lower_limit="0.399" upper_limit="1.095"/>
                    <measurement group_id="O2" value="0.313" lower_limit="0.176" upper_limit="0.556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 60 minutes post-chamber entry; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.588" lower_limit="0.288" upper_limit="1.203"/>
                    <measurement group_id="O2" value="0.270" lower_limit="0.140" upper_limit="0.521"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, immediately post-exercise; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.379" lower_limit="0.675" upper_limit="2.817"/>
                    <measurement group_id="O2" value="0.337" lower_limit="0.193" upper_limit="0.587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, immediately post-chamber exit; n=10,10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.001" lower_limit="0.449" upper_limit="2.232"/>
                    <measurement group_id="O2" value="0.310" lower_limit="0.170" upper_limit="0.566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 30 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.754" lower_limit="0.366" upper_limit="1.553"/>
                    <measurement group_id="O2" value="0.263" lower_limit="0.147" upper_limit="0.471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, End of infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.346" lower_limit="0.950" upper_limit="1.908"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 15 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.658" lower_limit="1.179" upper_limit="2.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 15 to 45 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.686" lower_limit="1.032" upper_limit="2.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 60 minutes post-chamber entry; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.072" lower_limit="0.916" upper_limit="1.254"/>
                    <measurement group_id="O2" value="2.615" lower_limit="1.407" upper_limit="4.861"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, immediately post-exercise; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="3.622" lower_limit="1.612" upper_limit="8.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, immediately post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="4.584" lower_limit="2.015" upper_limit="10.431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 30 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.179" lower_limit="1.285" upper_limit="3.695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, End of infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.489" lower_limit="0.976" upper_limit="2.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 15 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.402" lower_limit="1.481" upper_limit="3.895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 15 to 45 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.321" lower_limit="1.368" upper_limit="3.935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 60 minutes post-chamber entry; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.072" lower_limit="0.916" upper_limit="1.254"/>
                    <measurement group_id="O2" value="3.007" lower_limit="1.269" upper_limit="7.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, immediately post-exercise; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.094" lower_limit="0.893" upper_limit="1.340"/>
                    <measurement group_id="O2" value="5.149" lower_limit="2.299" upper_limit="11.532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, immediately post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.108" lower_limit="0.879" upper_limit="1.396"/>
                    <measurement group_id="O2" value="5.991" lower_limit="2.505" upper_limit="14.327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 30 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="3.020" lower_limit="1.542" upper_limit="5.915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in RAS Peptides-Part 2</title>
        <description>Blood samples were collected to analyze RAS peptides such as Ang II, Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.</description>
        <time_frame>Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in RAS Peptides-Part 2</title>
          <description>Blood samples were collected to analyze RAS peptides such as Ang II, Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.</description>
          <population>mITT2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).</population>
          <units>Picograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ang II, End of infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.603" lower_limit="0.139" upper_limit="2.621"/>
                    <measurement group_id="O2" value="0.500" lower_limit="0.143" upper_limit="1.743"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 15 minutes post-infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.564" lower_limit="0.146" upper_limit="2.178"/>
                    <measurement group_id="O2" value="0.391" lower_limit="0.122" upper_limit="1.255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 15 to 45 minutes post-infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.596" lower_limit="0.140" upper_limit="2.536"/>
                    <measurement group_id="O2" value="0.391" lower_limit="0.122" upper_limit="1.255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 60 minutes post-chamber entry; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.532" lower_limit="0.181" upper_limit="1.568"/>
                    <measurement group_id="O2" value="0.467" lower_limit="0.142" upper_limit="1.532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, immediately post-exercise; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.447" lower_limit="0.127" upper_limit="1.570"/>
                    <measurement group_id="O2" value="0.452" lower_limit="0.140" upper_limit="1.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, immediately post-chamber exit; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.604" lower_limit="0.212" upper_limit="1.725"/>
                    <measurement group_id="O2" value="0.391" lower_limit="0.122" upper_limit="1.255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang II, 30 minutes post-chamber exit; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.358" lower_limit="0.060" upper_limit="2.151"/>
                    <measurement group_id="O2" value="0.472" lower_limit="0.143" upper_limit="1.559"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, End of infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.285" lower_limit="0.640" upper_limit="2.581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 15 minutes post-infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.123" lower_limit="0.762" upper_limit="5.913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 15 to 45 minutes post-infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.782" lower_limit="0.659" upper_limit="4.821"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 60 minutes post-chamber entry; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.469" lower_limit="0.844" upper_limit="7.229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, immediately post-exercise; n=3, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.992" lower_limit="0.833" upper_limit="4.763"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, immediately post-chamber exit; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.668" lower_limit="0.644" upper_limit="4.319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-7, 30 minutes post-chamber exit; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.105" lower_limit="0.865" upper_limit="5.123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, End of infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="1.998" lower_limit="0.814" upper_limit="4.901"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 15 minutes post-infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.151" lower_limit="0.849" upper_limit="5.452"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 15 to 45 minutes post-infusion; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.722" lower_limit="1.222" upper_limit="6.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 60 minutes post-chamber entry; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.426" lower_limit="0.461" upper_limit="4.417"/>
                    <measurement group_id="O2" value="3.053" lower_limit="0.786" upper_limit="11.861"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, immediately post-exercise; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.498" lower_limit="0.814" upper_limit="7.673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, immediately post-chamber exit; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.246" lower_limit="0.481" upper_limit="10.493"/>
                    <measurement group_id="O2" value="2.417" lower_limit="0.842" upper_limit="6.937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ang 1-5, 30 minutes post-chamber exit; n=4, 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="NA" upper_limit="NA">Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification</measurement>
                    <measurement group_id="O2" value="2.561" lower_limit="1.140" upper_limit="5.752"/>
                  </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)-Part 1</title>
        <description>SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1</title>
          <description>SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
          <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP; 15 to 45 minutes post infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="3.30"/>
                    <measurement group_id="O2" value="-5.9" spread="6.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP; immediately post-exercise; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="12.89"/>
                    <measurement group_id="O2" value="-3.0" spread="14.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP; 60 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="4.14"/>
                    <measurement group_id="O2" value="-6.2" spread="7.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; 15 to 45 minutes post infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="6.41"/>
                    <measurement group_id="O2" value="-1.2" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; immediately post-exercise; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="12.40"/>
                    <measurement group_id="O2" value="0.3" spread="7.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; 60 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="7.94"/>
                    <measurement group_id="O2" value="-1.4" spread="7.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SBP and DBP-Part 2</title>
        <description>SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SBP and DBP-Part 2</title>
          <description>SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
          <population>mITT2 Population</population>
          <units>Millimeters of mercury</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP; 15 to 45 minutes post infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="7.00"/>
                    <measurement group_id="O2" value="-2.2" spread="7.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP; immediately post-exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" spread="14.64"/>
                    <measurement group_id="O2" value="-9.5" spread="12.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP; 60 minutes post-chamber exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="8.94"/>
                    <measurement group_id="O2" value="-1.5" spread="4.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; 15 to 45 minutes post infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3" spread="5.39"/>
                    <measurement group_id="O2" value="-0.8" spread="8.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; immediately post-exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" spread="10.75"/>
                    <measurement group_id="O2" value="-6.0" spread="8.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP; 60 minutes post-chamber exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="9.77"/>
                    <measurement group_id="O2" value="3.3" spread="7.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heart Rate-Part 1</title>
        <description>Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heart Rate-Part 1</title>
          <description>Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
          <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, 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="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 to 45 minutes post infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="4.45"/>
                    <measurement group_id="O2" value="1.2" spread="5.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-exercise; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" spread="7.48"/>
                    <measurement group_id="O2" value="37.7" spread="10.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="6.33"/>
                    <measurement group_id="O2" value="7.7" spread="7.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heart Rate-Part 2</title>
        <description>Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
        <time_frame>Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heart Rate-Part 2</title>
          <description>Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.</description>
          <population>mITT2 Population</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 to 45 minutes post infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="3.44"/>
                    <measurement group_id="O2" value="0.0" spread="3.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="7.78"/>
                    <measurement group_id="O2" value="16.3" spread="7.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="4.51"/>
                    <measurement group_id="O2" value="1.5" spread="4.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Oxygen Saturation-Part 1</title>
        <description>Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.</description>
        <time_frame>Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Oxygen Saturation-Part 1</title>
          <description>Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.</description>
          <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Percentage of oxygen</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes post-infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.626" lower_limit="0.614" upper_limit="2.635"/>
                    <measurement group_id="O2" value="1.478" lower_limit="0.467" upper_limit="2.493"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber entry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.663" lower_limit="-13.599" upper_limit="-7.733"/>
                    <measurement group_id="O2" value="-11.835" lower_limit="-14.772" upper_limit="-8.897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.257" lower_limit="-17.397" upper_limit="-11.109"/>
                    <measurement group_id="O2" value="-14.426" lower_limit="-17.590" upper_limit="-11.279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-chamber exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.235" lower_limit="-0.774" upper_limit="1.251"/>
                    <measurement group_id="O2" value="-0.132" lower_limit="-1.144" upper_limit="0.880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.148</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.5622</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.264</ci_lower_limit>
            <ci_upper_limit>0.973</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-1.172</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.0720</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.271</ci_lower_limit>
            <ci_upper_limit>2.942</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.169</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.2351</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.624</ci_lower_limit>
            <ci_upper_limit>4.258</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.367</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.5649</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.498</ci_lower_limit>
            <ci_upper_limit>0.753</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Oxygen Saturation-Part 2</title>
        <description>Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.</description>
        <time_frame>Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start, 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Oxygen Saturation-Part 2</title>
          <description>Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.</description>
          <population>mITT2 Population</population>
          <units>Percentage of oxygen</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>15 minutes post-infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.644" lower_limit="-0.602" upper_limit="1.892"/>
                    <measurement group_id="O2" value="0.847" lower_limit="-0.416" upper_limit="2.090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber entry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.707" lower_limit="-26.345" upper_limit="-21.053"/>
                    <measurement group_id="O2" value="-19.945" lower_limit="-22.585" upper_limit="-17.302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 minutes post-exercise start</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.399" lower_limit="-26.372" upper_limit="-18.415"/>
                    <measurement group_id="O2" value="-23.433" lower_limit="-27.400" upper_limit="-19.484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-chamber exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.691" lower_limit="0.614" upper_limit="2.763"/>
                    <measurement group_id="O2" value="0.821" lower_limit="-0.246" upper_limit="1.918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>0.203</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.8872</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.578</ci_lower_limit>
            <ci_upper_limit>1.968</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>3.760</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>1.8799</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.001</ci_lower_limit>
            <ci_upper_limit>7.495</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-1.029</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>2.8146</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.673</ci_lower_limit>
            <ci_upper_limit>4.578</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Difference (Net)</param_type>
            <param_value>-0.873</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>0.7620</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.380</ci_lower_limit>
            <ci_upper_limit>0.669</ci_upper_limit>
            <estimate_desc>Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part 1</title>
        <description>Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.</description>
        <time_frame>pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part 1</title>
          <description>Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.</description>
          <population>mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NCS; pre-dose; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CS; pre-dose; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>NCS; 15 to 45 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CS; 15 to 45 minutes post-infusion; n=10, 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>NCS: 60 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CS: 60 minutes post-chamber exit; n=10, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal ECG Findings-Part 2</title>
        <description>Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTc intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.</description>
        <time_frame>pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal ECG Findings-Part 2</title>
          <description>Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTc intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.</description>
          <population>mITT2 Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NCS; pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CS; pre-dose</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>NCS; 15 to 45 minutes post-infusion</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>CS; 15 to 45 minutes post-infusion</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>NCS: 60 minutes post-chamber exit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CS: 60 minutes post-chamber exit</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 Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1</title>
        <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1</title>
          <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.</description>
          <population>mITT1 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="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>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 AEs and SAEs-Part 2</title>
        <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AEs and SAEs-Part 2</title>
          <description>An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.</description>
          <population>mITT2 Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</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>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 Positive Immunogenicity Results-Part 1</title>
        <description>Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-angiotensin converting enzyme 2 (ACE2) binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Immunogenicity Results-Part 1</title>
          <description>Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-angiotensin converting enzyme 2 (ACE2) binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.</description>
          <population>mITT1 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="10"/>
                <count group_id="O2" value="11"/>
              </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 Positive Immunogenicity Results-Part 2</title>
        <description>Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Immunogenicity Results-Part 2</title>
          <description>Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.</description>
          <population>mITT2 Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Hematology Parameters-Part 1</title>
        <description>Blood samples were collected to analyze the following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Hematology Parameters-Part 1</title>
          <description>Blood samples were collected to analyze the following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.</description>
          <population>mITT1 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="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Hematology Parameters-Part 2</title>
        <description>Blood samples were collected to analyze the following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Hematology Parameters-Part 2</title>
          <description>Blood samples were collected to analyze the following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.</description>
          <population>mITT2 Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Clinical Chemistry Parameters-Part 1</title>
        <description>Blood samples were collected to analyze the following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Chemistry Parameters-Part 1</title>
          <description>Blood samples were collected to analyze the following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.</description>
          <population>mITT1 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="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Clinical Chemistry Parameters-Part 2</title>
        <description>Blood samples were collected to analyze the following clinical chemistry parameters: BUN, creatinine, glucose, potassium, sodium, calcium, AST, ALT, alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Chemistry Parameters-Part 2</title>
          <description>Blood samples were collected to analyze the following clinical chemistry parameters: BUN, creatinine, glucose, potassium, sodium, calcium, AST, ALT, alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.</description>
          <population>mITT2 Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Urine Parameters-Part 1</title>
        <description>Urine samples were collected to analyze the following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters are presented.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Urine Parameters-Part 1</title>
          <description>Urine samples were collected to analyze the following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters are presented.</description>
          <population>mITT1 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="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Urine Parameters-Part 2</title>
        <description>Urine samples were collected to analyze the following urine parameters: specific gravity, pH, glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters is presented.</description>
        <time_frame>Up to 26 days</time_frame>
        <population>mITT2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Placebo</title>
            <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Urine Parameters-Part 2</title>
          <description>Urine samples were collected to analyze the following urine parameters: specific gravity, pH, glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters is presented.</description>
          <population>mITT2 Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of GSK2586881-Part 1</title>
        <description>Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2586881. Pharmacokinetic Part1 (PK1) Population comprised of participants in the mITT population, randomized in Part 1 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of GSK2586881-Part 1</title>
          <description>Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2586881. Pharmacokinetic Part1 (PK1) Population comprised of participants in the mITT population, randomized in Part 1 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.</description>
          <population>PK1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)</population>
          <units>Nanograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-dose; n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>At infusion; n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10256.935" spread="2667.2276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-infusion; n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10862.467" spread="1765.2731"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 to 45 minutes post-infusion; n=11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9646.325" spread="1351.1030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber entry; n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6934.842" spread="860.4466"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-exercise; n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6698.518" spread="726.7099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-chamber exit; n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6304.675" spread="731.1517"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-chamber exit; n=10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5209.130" spread="543.4398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of GSK2586881-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. Pharmacokinetic Part2 (PK2) Population comprised of participants in the mITT population, randomized in Part 2 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of GSK2586881-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. Pharmacokinetic Part2 (PK2) Population comprised of participants in the mITT population, randomized in Part 2 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.</description>
          <population>PK2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)</population>
          <units>Nanograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-dose; n=5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">No concentration values detected for pre-dose</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At infusion; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20032.735" spread="2026.2004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 minutes post-infusion; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18269.882" spread="1790.1483"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 to 45 minutes post-infusion; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17484.102" spread="1374.5418"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 minutes post-chamber entry; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11617.538" spread="1572.8006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-exercise; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11818.457" spread="1950.1873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>immediately post-chamber exit; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10956.927" spread="1319.8536"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 minutes post-chamber exit; n=6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9886.477" spread="1428.6630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 1</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 1</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK1 Population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Hours*micrograms 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.977" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK2 Population</population>
          <units>Hours*micrograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.400" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 1</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population. Only those participants with data available at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 1</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK1 Population. Only those participants with data available at the specified time points were analyzed.</population>
          <units>Hours*micrograms 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="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.470" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK2 Population</population>
          <units>Hours*micrograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.838" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Concentration (Cmax) of GSK2586881-Part 1</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Concentration (Cmax) of GSK2586881-Part 1</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK1 Population</population>
          <units>Micrograms 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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.296" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax of GSK2586881-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax of GSK2586881-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK2 Population</population>
          <units>Micrograms per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.343" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Cmax (Tmax) of GSK2586881-Part 1</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Cmax (Tmax) of GSK2586881-Part 1</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK1 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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28333" lower_limit="0.0667" upper_limit="0.3833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax of GSK2586881-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax of GSK2586881-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK2 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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08333" lower_limit="0.0667" upper_limit="0.4667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Half-life (T1/2) of GSK2586881-Part 1</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (T1/2) of GSK2586881-Part 1</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK1 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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, T1/2 could not be estimated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>T1/2 of GSK2586881-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>T1/2 of GSK2586881-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK2 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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, T1/2 could not be estimated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance for GSK2586881-Part 1</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance for GSK2586881-Part 1</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK1 Population</population>
          <units>Liters per hour per kilogram</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, clearance could not be estimated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance for GSK2586881-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance for GSK2586881-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK2 Population</population>
          <units>Liters per hour per kilogram</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, clearance could not be estimated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution for GSK2586881-Part 1</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK1 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution for GSK2586881-Part 1</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK1 Population</population>
          <units>Liters per kilogram</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="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, volume of distribution could not be estimated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution for GSK2586881-Part 2</title>
        <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
        <time_frame>pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period</time_frame>
        <population>PK2 Population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: GSK2586881 0.8 mg/kg</title>
            <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution for GSK2586881-Part 2</title>
          <description>Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.</description>
          <population>PK2 Population</population>
          <units>Liters per kilogram</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, volume of distribution could not be estimated</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Non-serious AEs and SAEs were collected up to 26 days for Part 1 and Part 2</time_frame>
      <desc>Non-serious AEs and SAEs were collected in mITT1 Population for Part 1 and mITT2 Population for Part 2.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: Placebo</title>
          <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
        </group>
        <group group_id="E2">
          <title>Part 1: GSK2586881</title>
          <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 1 of the study. During each period, approximately 30 minutes after administration of study treatment, the participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 4000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 70% of maximum VO2 uptake on an upright cycle ergometer within the hypoxia chamber for 10 minutes.</description>
        </group>
        <group group_id="E3">
          <title>Part 2: Placebo</title>
          <description>Participants were administered a single IV dose of placebo in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</description>
        </group>
        <group group_id="E4">
          <title>Part 2: GSK2586881 0.8 mg/kg</title>
          <description>Participants were administered a single IV dose of 0.8 mg/kg GSK2586881 in either treatment period 1 or 2 during Part 2 of the study. During each period, approximately 30 minutes after administration of the study treatment, participants entered the hypoxia chamber and were inside the chamber for approximately 80 minutes, during which they were under the full 5000 meters ± 10% hypoxic conditions. Participants then performed an exercise challenge at 50% of maximum VO2 uptake on a semi-recumbent cycle ergometer within the hypoxia chamber for 10 minutes.</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000686
org study id: 204987
secondary id: 2016-002465-55
nct id: NCT03000686
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is conducted to examine how GSK2586881, a recombinant human ACE2 peptide,
      modulates the acute hypoxic pulmonary vasoconstriction (HPV) response in healthy volunteers.
      The study will be single-center, randomized, placebo-controlled and double blind (sponsor
      open). Subjects will be randomized to receive a single intravenous (IV) dose of GSK2586881 or
      placebo (saline) in a crossover design. The primary objective of the study is to evaluate the
      effect of a single IV dose of GSK2586881 on the HPV response in healthy volunteers during
      exercise under hypoxic conditions. Approximately 35 subjects will be enrolled for a maximum
      of 56 days.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change From Baseline of Pulmonary Artery Systolic Pressure (PASP) Measured Via Echocardiography-Part 1
time frame: Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise and 30 minutes post-chamber exit in each treatment period
description: Echocardiograms (Echo) were obtained at indicated time points with the participant resting supine or lying on their left side. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying the modified Bernoulli equation to convert this value into pressure values. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.
measure: Change From Baseline of PASP Measured Via Echocardiography-Part 2
time frame: Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start and 30 minutes post-chamber exit in each treatment period
description: Echocardiograms were obtained with participant resting supine or lying on their left side. Echo during exercise challenge was conducted with participant on a semi-recumbent cycle ergometer tilted by 30 to 40 degrees. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying modified Bernoulli equation to convert this value into pressure values. Change from Baseline is the post-dose visit value minus Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of the two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.
measure: Change From Baseline in Renin-angiotensin System (RAS) Peptides-Part 1
time frame: Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected to analyze RAS peptide biomarkers such as angiotensin II (Ang II), Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.
measure: Change From Baseline in RAS Peptides-Part 2
time frame: Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected to analyze RAS peptides such as Ang II, Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1
time frame: Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period
description: SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.
measure: Change From Baseline in SBP and DBP-Part 2
time frame: Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period
description: SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.
measure: Change From Baseline in Heart Rate-Part 1
time frame: Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period
description: Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.
measure: Change From Baseline in Heart Rate-Part 2
time frame: Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period
description: Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.
measure: Change From Baseline in Oxygen Saturation-Part 1
time frame: Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, 30 minutes post-chamber exit in each treatment period
description: Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.
measure: Change From Baseline in Oxygen Saturation-Part 2
time frame: Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start, 30 minutes post-chamber exit in each treatment period
description: Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part 1
time frame: pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period
description: Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.
measure: Number of Participants With Abnormal ECG Findings-Part 2
time frame: pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period
description: Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTc intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS 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.
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1
time frame: Up to 26 days
description: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
measure: Number of Participants With AEs and SAEs-Part 2
time frame: Up to 26 days
description: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
measure: Number of Participants With Positive Immunogenicity Results-Part 1
time frame: Up to 26 days
description: Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-angiotensin converting enzyme 2 (ACE2) binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.
measure: Number of Participants With Positive Immunogenicity Results-Part 2
time frame: Up to 26 days
description: Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.
measure: Number of Participants With Abnormal Hematology Parameters-Part 1
time frame: Up to 26 days
description: Blood samples were collected to analyze the following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.
measure: Number of Participants With Abnormal Hematology Parameters-Part 2
time frame: Up to 26 days
description: Blood samples were collected to analyze the following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.
measure: Number of Participants With Abnormal Clinical Chemistry Parameters-Part 1
time frame: Up to 26 days
description: Blood samples were collected to analyze the following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.
measure: Number of Participants With Abnormal Clinical Chemistry Parameters-Part 2
time frame: Up to 26 days
description: Blood samples were collected to analyze the following clinical chemistry parameters: BUN, creatinine, glucose, potassium, sodium, calcium, AST, ALT, alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.
measure: Number of Participants With Abnormal Urine Parameters-Part 1
time frame: Up to 26 days
description: Urine samples were collected to analyze the following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters are presented.
measure: Number of Participants With Abnormal Urine Parameters-Part 2
time frame: Up to 26 days
description: Urine samples were collected to analyze the following urine parameters: specific gravity, pH, glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters is presented.
measure: Plasma Concentrations of GSK2586881-Part 1
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2586881. Pharmacokinetic Part1 (PK1) Population comprised of participants in the mITT population, randomized in Part 1 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.
measure: Plasma Concentrations of GSK2586881-Part 2
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. Pharmacokinetic Part2 (PK2) Population comprised of participants in the mITT population, randomized in Part 2 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.
measure: Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 1
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 2
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 1
time frame: immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 2
time frame: immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Maximum Observed Concentration (Cmax) of GSK2586881-Part 1
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Cmax of GSK2586881-Part 2
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Time to Reach Cmax (Tmax) of GSK2586881-Part 1
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Tmax of GSK2586881-Part 2
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Apparent Terminal Half-life (T1/2) of GSK2586881-Part 1
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: T1/2 of GSK2586881-Part 2
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Clearance for GSK2586881-Part 1
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Clearance for GSK2586881-Part 2
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Volume of Distribution for GSK2586881-Part 1
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
measure: Volume of Distribution for GSK2586881-Part 2
time frame: pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period
description: Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
arm group label: Treatment sequence AB
arm group type: Experimental
description: Subjects will receive GSK2586881 in period 1 and saline placebo in period 2. There will be a washout period of 3-14 days between two treatments
arm group label: Treatment sequence BA
arm group type: Experimental
description: Subjects will receive saline placebo in period 1 and GSK2586881 in period 2. There will be a washout period of 3-14 days between two treatments
intervention type: Biological
intervention name: GSK2586881
description: GSK2586881 will be a clear colorless liquid for IV infusion over 3- 5 mins and will be administered as unit dose 0.8 mg/kg.
arm group label: Treatment sequence AB
arm group label: Treatment sequence BA
intervention type: Other
intervention name: Placebo
description: Normal saline (0.9%) will be administered as a single IV dose infusion over 3 to 5 min.
arm group label: Treatment sequence AB
arm group label: Treatment sequence BA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Hypoxia
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 