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Study of GSK2586881 on Acute Hypoxia and Exercise

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ClinicalTrials.gov Identifier: NCT03000686
Recruitment Status : Terminated (Study terminated for technical feasibility, operational considerations and futility in line with pre-specified criteria.)
First Posted : December 22, 2016
Results First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Healthy Volunteers
Interventions Biological: GSK2586881
Other: Placebo
Enrollment 17
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.
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.
Arm/Group Title Part 1: Placebo/GSK2586881 Part 1: GSK2586881/Placebo Part 2: Placebo/GSK2586881 Part 2: GSK2586881/Placebo
Hide Arm/Group 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. 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. 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. 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.
Period Title: Part 1, Period 1 (1 Day)
Started 5 6 0 0
Completed 5 5 0 0
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Period Title: Part 1, Wash-out (Up to 14 Days)
Started 5 5 0 0
Completed 5 5 0 0
Not Completed 0 0 0 0
Period Title: Part 1, Period 2 (1 Day)
Started 5 5 0 0
Completed 5 5 0 0
Not Completed 0 0 0 0
Period Title: Part 2, Period 1 (1 Day)
Started 0 0 3 3
Completed 0 0 3 3
Not Completed 0 0 0 0
Period Title: Part 2, Wash-out (Up to 14 Days)
Started 0 0 3 3
Completed 0 0 3 3
Not Completed 0 0 0 0
Period Title: Part 2, Period 2 (1 Day)
Started 0 0 3 3
Completed 0 0 3 3
Not Completed 0 0 0 0
Arm/Group Title All Participants-Part 1 All Participants-Part 2 Total
Hide Arm/Group 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 11 6 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 6 participants 17 participants
26.2  (4.24) 29.2  (6.21) 27.2  (5.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 17 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
11
 100.0%
6
 100.0%
17
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White - White/Caucasian/European Heritage Number Analyzed 11 participants 6 participants 17 participants
11
 100.0%
6
 100.0%
17
 100.0%
1.Primary Outcome
Title Change From Baseline of Pulmonary Artery Systolic Pressure (PASP) Measured Via Echocardiography-Part 1
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 10
Median (95% Confidence Interval)
Unit of Measure: Millimeters of mercury
15 minutes post-infusion
-0.715
(-3.626 to 2.122)
-0.695
(-3.610 to 2.153)
60 minutes post-chamber entry
4.299
(-0.052 to 8.633)
0.275
(-4.044 to 4.577)
immediately post-exercise
1.619
(-5.122 to 8.349)
-0.046
(-6.752 to 6.635)
30 minutes post-chamber exit
-0.189
(-3.590 to 3.097)
-1.026
(-4.393 to 2.284)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.021
Confidence Interval (2-Sided) 95%
-2.249 to 2.295
Parameter Dispersion
Type: Standard Deviation
Value: 1.1339
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -4.021
Confidence Interval (2-Sided) 95%
-9.168 to 1.146
Parameter Dispersion
Type: Standard Deviation
Value: 2.5923
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.668
Confidence Interval (2-Sided) 95%
-10.576 to 7.231
Parameter Dispersion
Type: Standard Deviation
Value: 4.4927
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.824
Confidence Interval (2-Sided) 95%
-4.142 to 2.506
Parameter Dispersion
Type: Standard Deviation
Value: 1.6695
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit
2.Primary Outcome
Title Change From Baseline of PASP Measured Via Echocardiography-Part 2
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: Millimeters of mercury
15 minutes post-infusion; n=6, 6 Number Analyzed 6 participants 6 participants
2.756
(-0.393 to 5.847)
2.093
(-1.009 to 5.246)
60 minutes post-chamber entry; n=6, 6 Number Analyzed 6 participants 6 participants
9.399
(4.572 to 14.234)
6.599
(1.697 to 11.439)
2 minutes post-exercise start; n=6, 5 Number Analyzed 6 participants 5 participants
14.665
(8.972 to 20.406)
14.646
(8.517 to 20.455)
30 minutes post-chamber exit; n=6, 6 Number Analyzed 6 participants 6 participants
4.156
(0.904 to 7.468)
3.867
(0.592 to 7.174)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.662
Confidence Interval (2-Sided) 95%
-5.037 to 3.815
Parameter Dispersion
Type: Standard Deviation
Value: 2.1933
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -2.796
Confidence Interval (2-Sided) 95%
-9.729 to 4.027
Parameter Dispersion
Type: Standard Deviation
Value: 3.4297
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.018
Confidence Interval (2-Sided) 95%
-8.475 to 8.086
Parameter Dispersion
Type: Standard Deviation
Value: 4.1450
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.291
Confidence Interval (2-Sided) 95%
-4.960 to 4.386
Parameter Dispersion
Type: Standard Deviation
Value: 2.3277
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit
3.Secondary Outcome
Title Change From Baseline in Renin-angiotensin System (RAS) Peptides-Part 1
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: Picograms per milliliter
Ang II, End of infusion; n=10, 11 Number Analyzed 10 participants 11 participants
0.551
(0.289 to 1.051)
0.278
(0.149 to 0.522)
Ang II, 15 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
0.649
(0.392 to 1.073)
0.305
(0.155 to 0.602)
Ang II, 15 to 45 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
0.661
(0.399 to 1.095)
0.313
(0.176 to 0.556)
Ang II, 60 minutes post-chamber entry; n=10, 10 Number Analyzed 10 participants 10 participants
0.588
(0.288 to 1.203)
0.270
(0.140 to 0.521)
Ang II, immediately post-exercise; n=10, 10 Number Analyzed 10 participants 10 participants
1.379
(0.675 to 2.817)
0.337
(0.193 to 0.587)
Ang II, immediately post-chamber exit; n=10,10 Number Analyzed 10 participants 10 participants
1.001
(0.449 to 2.232)
0.310
(0.170 to 0.566)
Ang II, 30 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
0.754
(0.366 to 1.553)
0.263
(0.147 to 0.471)
Ang 1-7, End of infusion; n=10, 11 Number Analyzed 10 participants 11 participants
1.000 [1] 
(NA to NA)
1.346
(0.950 to 1.908)
Ang 1-7, 15 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
1.000 [1] 
(NA to NA)
1.658
(1.179 to 2.331)
Ang 1-7, 15 to 45 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
1.000 [1] 
(NA to NA)
1.686
(1.032 to 2.755)
Ang 1-7, 60 minutes post-chamber entry; n=10, 10 Number Analyzed 10 participants 10 participants
1.072
(0.916 to 1.254)
2.615
(1.407 to 4.861)
Ang 1-7, immediately post-exercise; n=10, 10 Number Analyzed 10 participants 10 participants
1.000 [1] 
(NA to NA)
3.622
(1.612 to 8.141)
Ang 1-7, immediately post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
1.000 [1] 
(NA to NA)
4.584
(2.015 to 10.431)
Ang 1-7, 30 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
1.000 [1] 
(NA to NA)
2.179
(1.285 to 3.695)
Ang 1-5, End of infusion; n=10, 11 Number Analyzed 10 participants 11 participants
1.000 [1] 
(NA to NA)
1.489
(0.976 to 2.273)
Ang 1-5, 15 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
1.000 [1] 
(NA to NA)
2.402
(1.481 to 3.895)
Ang 1-5, 15 to 45 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
1.000 [1] 
(NA to NA)
2.321
(1.368 to 3.935)
Ang 1-5, 60 minutes post-chamber entry; n=10, 10 Number Analyzed 10 participants 10 participants
1.072
(0.916 to 1.254)
3.007
(1.269 to 7.123)
Ang 1-5, immediately post-exercise; n=10, 10 Number Analyzed 10 participants 10 participants
1.094
(0.893 to 1.340)
5.149
(2.299 to 11.532)
Ang 1-5, immediately post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
1.108
(0.879 to 1.396)
5.991
(2.505 to 14.327)
Ang 1-5, 30 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
1.000 [1] 
(NA to NA)
3.020
(1.542 to 5.915)
[1]
Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification
4.Secondary Outcome
Title Change From Baseline in RAS Peptides-Part 2
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 4 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: Picograms per milliliter
Ang II, End of infusion; n=4, 5 Number Analyzed 4 participants 5 participants
0.603
(0.139 to 2.621)
0.500
(0.143 to 1.743)
Ang II, 15 minutes post-infusion; n=4, 5 Number Analyzed 4 participants 5 participants
0.564
(0.146 to 2.178)
0.391
(0.122 to 1.255)
Ang II, 15 to 45 minutes post-infusion; n=4, 5 Number Analyzed 4 participants 5 participants
0.596
(0.140 to 2.536)
0.391
(0.122 to 1.255)
Ang II, 60 minutes post-chamber entry; n=4, 5 Number Analyzed 4 participants 5 participants
0.532
(0.181 to 1.568)
0.467
(0.142 to 1.532)
Ang II, immediately post-exercise; n=4, 5 Number Analyzed 4 participants 5 participants
0.447
(0.127 to 1.570)
0.452
(0.140 to 1.454)
Ang II, immediately post-chamber exit; n=4, 5 Number Analyzed 4 participants 5 participants
0.604
(0.212 to 1.725)
0.391
(0.122 to 1.255)
Ang II, 30 minutes post-chamber exit; n=4, 5 Number Analyzed 4 participants 5 participants
0.358
(0.060 to 2.151)
0.472
(0.143 to 1.559)
Ang 1-7, End of infusion; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
1.285
(0.640 to 2.581)
Ang 1-7, 15 minutes post-infusion; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
2.123
(0.762 to 5.913)
Ang 1-7, 15 to 45 minutes post-infusion; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
1.782
(0.659 to 4.821)
Ang 1-7, 60 minutes post-chamber entry; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
2.469
(0.844 to 7.229)
Ang 1-7, immediately post-exercise; n=3, 5 Number Analyzed 3 participants 5 participants
1.000 [1] 
(NA to NA)
1.992
(0.833 to 4.763)
Ang 1-7, immediately post-chamber exit; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
1.668
(0.644 to 4.319)
Ang 1-7, 30 minutes post-chamber exit; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
2.105
(0.865 to 5.123)
Ang 1-5, End of infusion; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
1.998
(0.814 to 4.901)
Ang 1-5, 15 minutes post-infusion; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
2.151
(0.849 to 5.452)
Ang 1-5, 15 to 45 minutes post-infusion; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
2.722
(1.222 to 6.063)
Ang 1-5, 60 minutes post-chamber entry; n=4, 5 Number Analyzed 4 participants 5 participants
1.426
(0.461 to 4.417)
3.053
(0.786 to 11.861)
Ang 1-5, immediately post-exercise; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
2.498
(0.814 to 7.673)
Ang 1-5, immediately post-chamber exit; n=4, 5 Number Analyzed 4 participants 5 participants
2.246
(0.481 to 10.493)
2.417
(0.842 to 6.937)
Ang 1-5, 30 minutes post-chamber exit; n=4, 5 Number Analyzed 4 participants 5 participants
1.000 [1] 
(NA to NA)
2.561
(1.140 to 5.752)
[1]
Confidence interval could not be estimated as more than 75% of the values were below lower limit of quantification
5.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
SBP; 15 to 45 minutes post infusion; n=10, 11 Number Analyzed 10 participants 11 participants
-1.0  (3.30) -5.9  (6.88)
SBP; immediately post-exercise; n=10, 10 Number Analyzed 10 participants 10 participants
5.4  (12.89) -3.0  (14.02)
SBP; 60 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
-4.0  (4.14) -6.2  (7.28)
DBP; 15 to 45 minutes post infusion; n=10, 11 Number Analyzed 10 participants 11 participants
0.3  (6.41) -1.2  (4.24)
DBP; immediately post-exercise; n=10, 10 Number Analyzed 10 participants 10 participants
6.7  (12.40) 0.3  (7.78)
DBP; 60 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
0.0  (7.94) -1.4  (7.57)
6.Secondary Outcome
Title Change From Baseline in SBP and DBP-Part 2
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
SBP; 15 to 45 minutes post infusion -3.3  (7.00) -2.2  (7.36)
SBP; immediately post-exercise -9.0  (14.64) -9.5  (12.85)
SBP; 60 minutes post-chamber exit 0.0  (8.94) -1.5  (4.37)
DBP; 15 to 45 minutes post infusion -5.3  (5.39) -0.8  (8.50)
DBP; immediately post-exercise -9.0  (10.75) -6.0  (8.10)
DBP; 60 minutes post-chamber exit 1.5  (9.77) 3.3  (7.09)
7.Secondary Outcome
Title Change From Baseline in Heart Rate-Part 1
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: Beats per minute
15 to 45 minutes post infusion; n=10, 11 Number Analyzed 10 participants 11 participants
-3.6  (4.45) 1.2  (5.36)
immediately post-exercise; n=10, 10 Number Analyzed 10 participants 10 participants
32.0  (7.48) 37.7  (10.92)
60 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
7.4  (6.33) 7.7  (7.26)
8.Secondary Outcome
Title Change From Baseline in Heart Rate-Part 2
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: Beats per minute
15 to 45 minutes post infusion -3.7  (3.44) 0.0  (3.90)
immediately post-exercise 11.8  (7.78) 16.3  (7.37)
60 minutes post-chamber exit -1.5  (4.51) 1.5  (4.42)
9.Secondary Outcome
Title Change From Baseline in Oxygen Saturation-Part 1
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 10
Median (95% Confidence Interval)
Unit of Measure: Percentage of oxygen
15 minutes post-infusion
1.626
(0.614 to 2.635)
1.478
(0.467 to 2.493)
60 minutes post-chamber entry
-10.663
(-13.599 to -7.733)
-11.835
(-14.772 to -8.897)
immediately post-exercise
-14.257
(-17.397 to -11.109)
-14.426
(-17.590 to -11.279)
30 minutes post-chamber exit
0.235
(-0.774 to 1.251)
-0.132
(-1.144 to 0.880)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.148
Confidence Interval (2-Sided) 95%
-1.264 to 0.973
Parameter Dispersion
Type: Standard Deviation
Value: 0.5622
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.172
Confidence Interval (2-Sided) 95%
-5.271 to 2.942
Parameter Dispersion
Type: Standard Deviation
Value: 2.0720
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.169
Confidence Interval (2-Sided) 95%
-4.624 to 4.258
Parameter Dispersion
Type: Standard Deviation
Value: 2.2351
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 1: Placebo, Part 1: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.367
Confidence Interval (2-Sided) 95%
-1.498 to 0.753
Parameter Dispersion
Type: Standard Deviation
Value: 0.5649
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.
10.Secondary Outcome
Title Change From Baseline in Oxygen Saturation-Part 2
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: Percentage of oxygen
15 minutes post-infusion
0.644
(-0.602 to 1.892)
0.847
(-0.416 to 2.090)
60 minutes post-chamber entry
-23.707
(-26.345 to -21.053)
-19.945
(-22.585 to -17.302)
2 minutes post-exercise start
-22.399
(-26.372 to -18.415)
-23.433
(-27.400 to -19.484)
30 minutes post-chamber exit
1.691
(0.614 to 2.763)
0.821
(-0.246 to 1.918)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0.203
Confidence Interval (2-Sided) 95%
-1.578 to 1.968
Parameter Dispersion
Type: Standard Deviation
Value: 0.8872
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 3.760
Confidence Interval (2-Sided) 95%
-0.001 to 7.495
Parameter Dispersion
Type: Standard Deviation
Value: 1.8799
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -1.029
Confidence Interval (2-Sided) 95%
-6.673 to 4.578
Parameter Dispersion
Type: Standard Deviation
Value: 2.8146
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: GSK2586881 0.8 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.873
Confidence Interval (2-Sided) 95%
-2.380 to 0.669
Parameter Dispersion
Type: Standard Deviation
Value: 0.7620
Estimation Comments Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.
11.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part 1
Hide 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.
Time Frame pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
NCS; pre-dose; n=10, 11 Number Analyzed 10 participants 11 participants
8
  80.0%
5
  45.5%
CS; pre-dose; n=10, 11 Number Analyzed 10 participants 11 participants
0
   0.0%
0
   0.0%
NCS; 15 to 45 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
7
  70.0%
7
  63.6%
CS; 15 to 45 minutes post-infusion; n=10, 11 Number Analyzed 10 participants 11 participants
0
   0.0%
0
   0.0%
NCS: 60 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
1
  10.0%
3
  30.0%
CS: 60 minutes post-chamber exit; n=10, 10 Number Analyzed 10 participants 10 participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Abnormal ECG Findings-Part 2
Hide 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.
Time Frame pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
NCS; pre-dose
3
  50.0%
6
 100.0%
CS; pre-dose
0
   0.0%
0
   0.0%
NCS; 15 to 45 minutes post-infusion
4
  66.7%
5
  83.3%
CS; 15 to 45 minutes post-infusion
0
   0.0%
0
   0.0%
NCS: 60 minutes post-chamber exit
3
  50.0%
4
  66.7%
CS: 60 minutes post-chamber exit
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
3
  30.0%
2
  18.2%
SAEs
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With AEs and SAEs-Part 2
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
1
  16.7%
0
   0.0%
SAEs
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Positive Immunogenicity Results-Part 1
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Positive Immunogenicity Results-Part 2
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Abnormal Hematology Parameters-Part 1
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Abnormal Hematology Parameters-Part 2
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Participants With Abnormal Clinical Chemistry Parameters-Part 1
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
  27.3%
20.Secondary Outcome
Title Number of Participants With Abnormal Clinical Chemistry Parameters-Part 2
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Abnormal Urine Parameters-Part 1
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT1 Population
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
22.Secondary Outcome
Title Number of Participants With Abnormal Urine Parameters-Part 2
Hide 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.
Time Frame Up to 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
mITT2 Population
Arm/Group Title Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
23.Secondary Outcome
Title Plasma Concentrations of GSK2586881-Part 1
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter
pre-dose; n=11 Number Analyzed 11 participants
NA [1]   (NA)
At infusion; n=11 Number Analyzed 11 participants
10256.935  (2667.2276)
15 minutes post-infusion; n=11 Number Analyzed 11 participants
10862.467  (1765.2731)
15 to 45 minutes post-infusion; n=11 Number Analyzed 11 participants
9646.325  (1351.1030)
60 minutes post-chamber entry; n=10 Number Analyzed 10 participants
6934.842  (860.4466)
immediately post-exercise; n=10 Number Analyzed 10 participants
6698.518  (726.7099)
immediately post-chamber exit; n=10 Number Analyzed 10 participants
6304.675  (731.1517)
30 minutes post-chamber exit; n=10 Number Analyzed 10 participants
5209.130  (543.4398)
[1]
No concentration values detected for pre-dose
24.Secondary Outcome
Title Plasma Concentrations of GSK2586881-Part 2
Hide 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: Nanograms per milliliter
pre-dose; n=5 Number Analyzed 5 participants
NA [1]   (NA)
At infusion; n=6 Number Analyzed 6 participants
20032.735  (2026.2004)
15 minutes post-infusion; n=6 Number Analyzed 6 participants
18269.882  (1790.1483)
15 to 45 minutes post-infusion; n=6 Number Analyzed 6 participants
17484.102  (1374.5418)
60 minutes post-chamber entry; n=6 Number Analyzed 6 participants
11617.538  (1572.8006)
immediately post-exercise; n=6 Number Analyzed 6 participants
11818.457  (1950.1873)
immediately post-chamber exit; n=6 Number Analyzed 6 participants
10956.927  (1319.8536)
30 minutes post-chamber exit; n=6 Number Analyzed 6 participants
9886.477  (1428.6630)
[1]
No concentration values detected for pre-dose
25.Secondary Outcome
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
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK1 Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*micrograms per milliliter
19.977
(14.3%)
26.Secondary Outcome
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
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK2 Population
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*micrograms per milliliter
32.400
(9.2%)
27.Secondary Outcome
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
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK1 Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*micrograms per milliliter
12.470
(14.3%)
28.Secondary Outcome
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
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Time Frame immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
PK2 Population
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*micrograms per milliliter
18.838
(7.8%)
29.Secondary Outcome
Title Maximum Observed Concentration (Cmax) of GSK2586881-Part 1
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
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Hide Analysis Population Description
PK1 Population
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
11.296
(17.5%)
30.Secondary Outcome
Title Cmax of GSK2586881-Part 2
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK2 Population
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
20.343
(6.5%)
31.Secondary Outcome
Title Time to Reach Cmax (Tmax) of GSK2586881-Part 1
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK1 Population
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: Hours
0.28333
(0.0667 to 0.3833)
32.Secondary Outcome
Title Tmax of GSK2586881-Part 2
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK2 Population
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: Hours
0.08333
(0.0667 to 0.4667)
33.Secondary Outcome
Title Apparent Terminal Half-life (T1/2) of GSK2586881-Part 1
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK1 Population
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
NA [1] 
(NA%)
[1]
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, T1/2 could not be estimated.
34.Secondary Outcome
Title T1/2 of GSK2586881-Part 2
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK2 Population
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
NA [1] 
(NA%)
[1]
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, T1/2 could not be estimated
35.Secondary Outcome
Title Clearance for GSK2586881-Part 1
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK1 Population
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour per kilogram
NA [1] 
(NA%)
[1]
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, clearance could not be estimated
36.Secondary Outcome
Title Clearance for GSK2586881-Part 2
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK2 Population
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour per kilogram
NA [1] 
(NA%)
[1]
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, clearance could not be estimated
37.Secondary Outcome
Title Volume of Distribution for GSK2586881-Part 1
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
Hide Outcome Measure Data
Hide Analysis Population Description
PK1 Population
Arm/Group Title Part 1: GSK2586881 0.8 mg/kg
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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.
Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per kilogram
NA [1] 
(NA%)
[1]
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
38.Secondary Outcome
Title Volume of Distribution for GSK2586881-Part 2
Hide Description Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
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
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PK2 Population
Arm/Group Title Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per kilogram
NA [1] 
(NA%)
[1]
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
Time Frame Non-serious AEs and SAEs were collected up to 26 days for Part 1 and Part 2
Adverse Event Reporting Description Non-serious AEs and SAEs were collected in mITT1 Population for Part 1 and mITT2 Population for Part 2.
 
Arm/Group Title Part 1: Placebo Part 1: GSK2586881 Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Hide Arm/Group 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. 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. 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. 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.
All-Cause Mortality
Part 1: Placebo Part 1: GSK2586881 Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/11 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Part 1: Placebo Part 1: GSK2586881 Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part 1: Placebo Part 1: GSK2586881 Part 2: Placebo Part 2: GSK2586881 0.8 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      2/11 (18.18%)      1/6 (16.67%)      0/6 (0.00%)    
Infections and infestations         
Upper respiratory tract infection  1  1/10 (10.00%)  1 1/11 (9.09%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nasopharyngitis  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Respiratory tract infection  1  1/10 (10.00%)  1 0/11 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders         
Headache  1  1/10 (10.00%)  1 0/11 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Presyncope  1  0/10 (0.00%)  0 1/11 (9.09%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03000686    
Other Study ID Numbers: 204987
2016-002465-55 ( EudraCT Number )
First Submitted: December 19, 2016
First Posted: December 22, 2016
Results First Submitted: December 3, 2019
Results First Posted: December 23, 2019
Last Update Posted: December 23, 2019