Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects (NCT NCT03874234)
NCT ID: NCT03874234
Last Updated: 2023-02-27
Results Overview
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Up to Week 12
Results posted on
2023-02-27
Participant Flow
This was 2-part study. Part A comprised of 3 Cohorts (Cohorts 1, 2 and 3); Part B comprised 3 cohorts (Cohorts 4, 5 and 6). Study was terminated after completion of Cohort 2, Period 3 of Part A following strategic review after emergence of nonclinical data with non-GlaxoSmithKline asset. Hence, no participants were enrolled in Cohort 2 Period 4 and Cohort 3 of Part A and in all Cohorts of Part B.
A total 25 participants were enrolled (Enrolled Population consisted of all participants who passed screening and entered the study) in this study (Part A: Cohort 1- 11 participants, Cohort 2- 14 participants). Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Participant milestones
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Part A:Cohort 1-Placebo/GSK3186899 60 mg/120 mg/300 mg
Participants in Part A Cohort 1 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
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Part A:Cohort 2-GSK3186899 300 mg/600 mg/800 mg/Placebo
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
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Part A: Cohort 1-GSK3186899 30 mg/60 mg/120 mg/Placebo
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 milligram (mg) on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
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Part A:Cohort 1-GSK3186899 30 mg/60 mg/Placebo/300 mg
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
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Part A:Cohort 1-GSK3186899 30 mg/Placebo/120 mg/300 mg
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
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Part A:Cohort 2-GSK3186899 300 mg/600 mg/Placebo/Dose Level 7
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
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Part A:Cohort 2-GSK3186899 300 mg/Placebo/800 mg/Dose Level 7
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
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Part A:Cohort 2-Placebo/GSK3186899 600 mg/800 mg/Dose Level 7
Participants in Part A Cohort 2 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
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Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
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Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
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Part B: Cohort 4- GSK3186899 or Placebo
Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
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Part B: Cohort 5- GSK3186899 or Placebo
Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
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Part B: Cohort 6- GSK3186899 or Placebo
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
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Part A: Cohort 1-Period 1 (Day1)
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Part A: Cohort 3- Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohorts 4 to 6 (Days 1 to 10)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohorts 4 to 6 (Days 1 to 10)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B: Cohorts 4 to 6 (Days 1 to 10)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A:Cohort 1-Placebo/GSK3186899 60 mg/120 mg/300 mg
Participants in Part A Cohort 1 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-GSK3186899 300 mg/600 mg/800 mg/Placebo
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A: Cohort 1-GSK3186899 30 mg/60 mg/120 mg/Placebo
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 milligram (mg) on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 1-GSK3186899 30 mg/60 mg/Placebo/300 mg
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 1-GSK3186899 30 mg/Placebo/120 mg/300 mg
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-GSK3186899 300 mg/600 mg/Placebo/Dose Level 7
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-GSK3186899 300 mg/Placebo/800 mg/Dose Level 7
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-Placebo/GSK3186899 600 mg/800 mg/Dose Level 7
Participants in Part A Cohort 2 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
|
Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 4- GSK3186899 or Placebo
Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part B: Cohort 5- GSK3186899 or Placebo
Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part B: Cohort 6- GSK3186899 or Placebo
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Cohort 1-Period 1 (Day1)
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 1-Period 2 (Day1)
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 1-Period 3 (Day1)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 1 (Day1)
Randomized in error
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 1 (Day1)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 1 (Day1)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 2 (Day1)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort 2-Period 2 (Day1)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1-GSK3186899 30 mg/60 mg/120 mg/Placebo
n=3 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 milligram (mg) on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 1-GSK3186899 30 mg/60 mg/Placebo/300 mg
n=2 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 1-GSK3186899 30 mg/Placebo/120 mg/300 mg
n=2 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 1-Placebo/GSK3186899 60 mg/120 mg/300 mg
n=4 Participants
Participants in Part A Cohort 1 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3; further followed by a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-GSK3186899 300 mg/600 mg/800 mg/Placebo
n=4 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by a single dose of Placebo on Day 1 in treatment Period 4. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-GSK3186899 300 mg/600 mg/Placebo/Dose Level 7
n=3 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of Placebo on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-GSK3186899 300 mg/Placebo/800 mg/Dose Level 7
n=3 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 1; followed by a single dose of Placebo on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
|
Part A:Cohort 2-Placebo/GSK3186899 600 mg/800 mg/Dose Level 7
n=3 Participants
Participants in Part A Cohort 2 received a single dose of Placebo on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2; followed by a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3; further followed by dose level 7 was planned to receive on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended. There was a washout period of 10 days between each treatment period.
|
Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 4- GSK3186899 or Placebo
Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part B: Cohort 5- GSK3186899 or Placebo
Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part B: Cohort 6- GSK3186899 or Placebo
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 6.51 • n=93 Participants
|
34.0 Years
STANDARD_DEVIATION 1.41 • n=4 Participants
|
33.0 Years
STANDARD_DEVIATION 8.49 • n=27 Participants
|
31.3 Years
STANDARD_DEVIATION 8.77 • n=483 Participants
|
34.5 Years
STANDARD_DEVIATION 13.20 • n=36 Participants
|
37.3 Years
STANDARD_DEVIATION 4.04 • n=10 Participants
|
39.7 Years
STANDARD_DEVIATION 8.50 • n=115 Participants
|
41.0 Years
STANDARD_DEVIATION 10.54 • n=40 Participants
|
—
|
—
|
—
|
—
|
—
|
36.9 Years
STANDARD_DEVIATION 8.76 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
24 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=129 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=14 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=6 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=6 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and SAEs
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and SAEs
Non-SAEs
|
5 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, important medical events that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
PCI ranges were \<0.0 or \>0.1\*10\^9 cells per(/)liter(L)(basophils), \<37 or \>50 proportion of red blood cells(RBC) in blood(hematocrit),\<130 or \>170 grams/L(hemoglobin\[Hb\]), \<1.2 or \>3.65\*10\^9cells(c)/L (lymphocytes),\<0.2 or \>1\*10\^9c/L(monocytes), \<2 or \>7.5\*10\^9c/L(neutrophils), \<150 or \>400\*10\^9 c/L(platelets), \<3.0 or \>10\*10\^9c/L(white blood cell\[WBC\]count), \<4.4 or \>5.8\*10\^12 c/L(RBC count), \<80 or \>99 femtoliter(mean corpuscular\[MC\] volume), \<26.0 or \>33.5 picogram(MC Hb), \<0.0 or \>0.4\*10\^9 c/L(eosinophils). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High) or whose value became within range, were recorded in To within Range or No Change category.Participants were counted twice if participant had values that changed To Low and To High, so the percentages may not add to 100 percentage(%).
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=14 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=6 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=6 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
MC Hb: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Basophils: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit: To within range or no change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin: To within range or no change
|
13 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin: To high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To low
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To within range or no change
|
12 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Monocytes: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Monocytes: To within range or no change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Monocytes: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils: To low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils: To within range or no change
|
12 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
5 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils: To high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets: To within range or no change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RBC count: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RBC count: To within range or no change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RBC count: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
WBC count: To low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
WBC count: To within range or no change
|
12 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
WBC count: To high
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
MC volume: To low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
MC volume: To within range or no change
|
13 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
MC volume: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
MC Hb: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
MC Hb: To within range or no change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Eosinophils: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Eosinophils: To within range or no change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Eosinophils: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Basophils: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Basophils: To within range or no change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
5 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected to analyze hematology parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze hematology parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
PCI ranges were \<34 or \>50 grams/L(albumin),\<40 or \>129 international units/L\[IU/L\](alkaline phosphatase),\<10 or \>50 IU/L(alanine aminotransferase),\<0 or \>37(aspartate aminotransferase), \<0 or \>20 micromoles(mcmol)/L (direct bilirubin),\<0 or \>20 mcmol/L(bilirubin), \<2.2 or \>2.6 millimoles/L(mmol/L)(calcium),\<66 or \>112 upper limit of normal mmol/L(creatinine), \<3.5 or \>5.1 mmol/L (potassium),\<0.6 or \>1 mmol/L (magnesium),\<0.87 or \>1.45mmol/L (phosphate),\<63 or \>83 g/L (protein),\<135 or \>145 mmol/L (sodium), \<0.0 or \>5.0 mg/L (C-reactive protein). Participants were counted in worst case category that their value changes to(low, within range \[WR\] or no change\[NC\] or high), unless there is NC in their category. Participants whose laboratory value category was unchanged (e.g. High to High) or whose value became WR, were recorded in To WR or NC category. Participants were counted twice if participant had values that changed To Low and To High, so percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=14 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=6 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=6 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Magnesium: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Phosphate: To low
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Phosphate: To within range or NC
|
12 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Phosphate: To high
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Protein: To low
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Protein: To within range or NC
|
13 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Protein: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Sodium: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Sodium: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Sodium: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
C-reactive protein: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
C-reactive protein: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
C-reactive protein: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Potassium: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Potassium: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Magnesium: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Magnesium: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Albumin: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Albumin: To within range or NC
|
11 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Albumin: To high
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Alkaline phosphatase: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Alkaline phosphatase: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Alkaline phosphatase: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Alanine aminotransferase: To low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Alanine aminotransferase: To within range or NC
|
13 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Alanine aminotransferase: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Aspartate aminotransferase: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Aspartate aminotransferase: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Aspartate aminotransferase: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Direct bilirubin: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Direct bilirubin: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Direct bilirubin: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Bilirubin: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Bilirubin: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Bilirubin: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Calcium: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Calcium: To within range or NC
|
14 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Calcium: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Creatinine: To low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Creatinine: To within range or NC
|
13 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Creatinine: To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline
Potassium: To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected to analyze chemistry parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze chemistry parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Urine samples were collected for analysis of occult blood, ketones and protein by a dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine occult blood and protein can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Number of participants with worst case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=14 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=6 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=6 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Ketones
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Occult blood
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst-Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Protein
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Urine samples were planned to be collected to analyze urine parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Urine samples were planned to be collected to analyze urine parameters.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=14 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=6 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=6 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Abnormal - not clinically significant
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Abnormal - clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and corrected QT intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Twelve lead ECGs were planned to be performed to measure PR interval, QRS duration, QT interval and corrected QT intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 12Population: Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiratory rate and body temperature and were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (millimeters of mercury \[mmHg\]): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), pulse rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute): \<10(low) or \>25(high) and body temperature (degrees Celsius) \<35 (low) or \>38 (high). Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category. Participants were counted twice if the participant had values that changed "To Low" and "To High", so the percentages may not add to 100%.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=14 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=6 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=6 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
SBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
DBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Pulse rate: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Pulse rate: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Pulse rate: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Respiratory rate: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
6 Participants
|
6 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Worst Case Vital Sign Results by PCI Criteria Post-Baseline Relative to Baseline
Body temperature: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 9Population: Safety Population. Data was not collected as no participants were enrolled in Part B.
Vital signs were planned to be measured in a semi-supine position after 5 minutes of rest.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 hours post-dosePopulation: Safety Population. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Continuous cardiac telemetry was performed in a supine position after at least 5 minutes of rest. Abnormal findings were categorized as CS and not NCS. Clinically significant abnormal findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=14 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=6 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=6 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Number of Participants With Abnormal Cardiac Telemetry Findings
Abnormal - not clinically significant
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Part A- Cohorts 1 and 2: Number of Participants With Abnormal Cardiac Telemetry Findings
Abnormal - clinically significant
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hours post-dosePopulation: Safety Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Continuous cardiac telemetry was planned to be performed in a supine position after at least 5 minutes of rest.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 hours post-dosePopulation: Safety Population. Data was not collected as no participants were enrolled in Part B.
Continuous cardiac telemetry was planned to be performed in a supine position after at least 5 minutes of rest.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol.Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3186899. PK Population consisted of all participants in the Safety Population who received at least 1 non-missing PK assessment.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=5 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=4 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=10 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
10 minutes
|
36.935 Nanogram per milliliter
Standard Deviation 43.8179
|
10.780 Nanogram per milliliter
Standard Deviation 7.4009
|
68.788 Nanogram per milliliter
Standard Deviation 50.1741
|
183.693 Nanogram per milliliter
Standard Deviation 151.2143
|
528.360 Nanogram per milliliter
Standard Deviation 530.7085
|
766.898 Nanogram per milliliter
Standard Deviation 691.4467
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
30 minutes
|
182.825 Nanogram per milliliter
Standard Deviation 69.0839
|
220.846 Nanogram per milliliter
Standard Deviation 78.8200
|
817.218 Nanogram per milliliter
Standard Deviation 528.0808
|
2112.646 Nanogram per milliliter
Standard Deviation 943.7797
|
5337.077 Nanogram per milliliter
Standard Deviation 1679.9417
|
7563.453 Nanogram per milliliter
Standard Deviation 3748.7402
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
1 hour
|
246.298 Nanogram per milliliter
Standard Deviation 89.0970
|
308.820 Nanogram per milliliter
Standard Deviation 76.3337
|
1217.430 Nanogram per milliliter
Standard Deviation 414.4935
|
2445.121 Nanogram per milliliter
Standard Deviation 846.7178
|
6213.155 Nanogram per milliliter
Standard Deviation 2228.1232
|
8148.812 Nanogram per milliliter
Standard Deviation 3230.8260
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
2 hours
|
169.883 Nanogram per milliliter
Standard Deviation 79.6579
|
266.122 Nanogram per milliliter
Standard Deviation 76.2478
|
1019.690 Nanogram per milliliter
Standard Deviation 317.4601
|
2740.957 Nanogram per milliliter
Standard Deviation 919.9618
|
6388.922 Nanogram per milliliter
Standard Deviation 1338.2507
|
8139.085 Nanogram per milliliter
Standard Deviation 1761.2188
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
2.5 hours
|
143.448 Nanogram per milliliter
Standard Deviation 69.7562
|
296.102 Nanogram per milliliter
Standard Deviation 44.6567
|
981.000 Nanogram per milliliter
Standard Deviation 287.9601
|
2661.372 Nanogram per milliliter
Standard Deviation 869.2819
|
6930.995 Nanogram per milliliter
Standard Deviation 1697.9608
|
7714.882 Nanogram per milliliter
Standard Deviation 2565.6688
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
3 hours
|
124.742 Nanogram per milliliter
Standard Deviation 67.6108
|
297.366 Nanogram per milliliter
Standard Deviation 98.0691
|
841.170 Nanogram per milliliter
Standard Deviation 203.0633
|
2496.468 Nanogram per milliliter
Standard Deviation 751.3136
|
7377.713 Nanogram per milliliter
Standard Deviation 1718.2385
|
8306.098 Nanogram per milliliter
Standard Deviation 2966.1881
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
4 hours
|
71.845 Nanogram per milliliter
Standard Deviation 41.2573
|
211.540 Nanogram per milliliter
Standard Deviation 98.3222
|
586.375 Nanogram per milliliter
Standard Deviation 187.1841
|
2202.511 Nanogram per milliliter
Standard Deviation 908.6908
|
5230.308 Nanogram per milliliter
Standard Deviation 1817.4993
|
6492.033 Nanogram per milliliter
Standard Deviation 2264.4485
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
5 hours
|
48.675 Nanogram per milliliter
Standard Deviation 29.1569
|
149.386 Nanogram per milliliter
Standard Deviation 77.3929
|
407.900 Nanogram per milliliter
Standard Deviation 132.1951
|
1715.797 Nanogram per milliliter
Standard Deviation 818.4628
|
3910.825 Nanogram per milliliter
Standard Deviation 1174.7813
|
5828.517 Nanogram per milliliter
Standard Deviation 1559.1849
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
6 hours
|
33.648 Nanogram per milliliter
Standard Deviation 18.7418
|
109.636 Nanogram per milliliter
Standard Deviation 61.8823
|
318.288 Nanogram per milliliter
Standard Deviation 101.9840
|
1413.953 Nanogram per milliliter
Standard Deviation 714.4323
|
3752.580 Nanogram per milliliter
Standard Deviation 662.1178
|
5010.553 Nanogram per milliliter
Standard Deviation 1424.1685
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
10 hours
|
9.447 Nanogram per milliliter
Standard Deviation 6.7790
|
30.156 Nanogram per milliliter
Standard Deviation 14.0233
|
111.350 Nanogram per milliliter
Standard Deviation 40.8868
|
673.839 Nanogram per milliliter
Standard Deviation 419.1869
|
2571.757 Nanogram per milliliter
Standard Deviation 1287.9872
|
3519.375 Nanogram per milliliter
Standard Deviation 1243.8441
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
12 hours
|
4.975 Nanogram per milliliter
Standard Deviation 3.8146
|
14.662 Nanogram per milliliter
Standard Deviation 9.4905
|
53.978 Nanogram per milliliter
Standard Deviation 33.6205
|
394.246 Nanogram per milliliter
Standard Deviation 259.4013
|
1818.825 Nanogram per milliliter
Standard Deviation 952.8830
|
2676.418 Nanogram per milliliter
Standard Deviation 1366.8170
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
Pre-dose
|
0.000 Nanogram per milliliter
Standard Deviation 0.0000
|
0.000 Nanogram per milliliter
Standard Deviation 0.0000
|
0.000 Nanogram per milliliter
Standard Deviation 0.0000
|
0.000 Nanogram per milliliter
Standard Deviation 0.0000
|
0.000 Nanogram per milliliter
Standard Deviation 0.0000
|
0.000 Nanogram per milliliter
Standard Deviation 0.0000
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
1.5 hours
|
193.372 Nanogram per milliliter
Standard Deviation 75.7409
|
292.106 Nanogram per milliliter
Standard Deviation 70.6847
|
1165.735 Nanogram per milliliter
Standard Deviation 405.0558
|
2809.873 Nanogram per milliliter
Standard Deviation 731.2502
|
6676.070 Nanogram per milliliter
Standard Deviation 1731.9990
|
7828.908 Nanogram per milliliter
Standard Deviation 1936.6359
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
8 hours
|
19.023 Nanogram per milliliter
Standard Deviation 12.4100
|
58.322 Nanogram per milliliter
Standard Deviation 30.3314
|
180.300 Nanogram per milliliter
Standard Deviation 67.3578
|
1008.525 Nanogram per milliliter
Standard Deviation 554.8121
|
3196.830 Nanogram per milliliter
Standard Deviation 1133.3168
|
4352.842 Nanogram per milliliter
Standard Deviation 1510.7803
|
—
|
—
|
|
Part A- Cohorts 1 and 2: Plasma Concentration After Single Dose Administration of GSK3186899
24 hours
|
0.000 Nanogram per milliliter
Standard Deviation 0.0000
|
1.526 Nanogram per milliliter
Standard Deviation 1.0015
|
4.078 Nanogram per milliliter
Standard Deviation 1.2666
|
39.462 Nanogram per milliliter
Standard Deviation 31.0353
|
457.593 Nanogram per milliliter
Standard Deviation 549.4177
|
787.852 Nanogram per milliliter
Standard Deviation 862.1917
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=5 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=4 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=10 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Time of Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3186899
|
725.40 Hours*nanogram per milliliter
Geometric Coefficient of Variation 41.62
|
1597.85 Hours*nanogram per milliliter
Geometric Coefficient of Variation 32.30
|
5268.31 Hours*nanogram per milliliter
Geometric Coefficient of Variation 31.32
|
18105.45 Hours*nanogram per milliliter
Geometric Coefficient of Variation 47.08
|
58201.67 Hours*nanogram per milliliter
Geometric Coefficient of Variation 29.14
|
77531.24 Hours*nanogram per milliliter
Geometric Coefficient of Variation 34.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=5 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=4 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=10 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Extrapolated to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3186899
|
739.13 Hours*nanogram per milliliter
Geometric Coefficient of Variation 42.31
|
1607.27 Hours*nanogram per milliliter
Geometric Coefficient of Variation 32.10
|
5287.60 Hours*nanogram per milliliter
Geometric Coefficient of Variation 31.20
|
18265.32 Hours*nanogram per milliliter
Geometric Coefficient of Variation 47.50
|
61539.43 Hours*nanogram per milliliter
Geometric Coefficient of Variation 35.59
|
83867.58 Hours*nanogram per milliliter
Geometric Coefficient of Variation 42.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=5 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=4 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=10 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3186899
|
239.206 Nanogram per milliliter
Geometric Coefficient of Variation 34.38
|
356.232 Nanogram per milliliter
Geometric Coefficient of Variation 19.32
|
1214.000 Nanogram per milliliter
Geometric Coefficient of Variation 29.72
|
3011.334 Nanogram per milliliter
Geometric Coefficient of Variation 37.57
|
8219.997 Nanogram per milliliter
Geometric Coefficient of Variation 15.50
|
9445.301 Nanogram per milliliter
Geometric Coefficient of Variation 28.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=5 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=4 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=10 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Time to Maximum Observed Plasma Drug Concentration (Tmax) After Single Dose Administration of GSK3186899
|
1.00 Hour
Interval 0.5 to 1.5
|
3.00 Hour
Interval 1.0 to 3.0
|
1.00 Hour
Interval 1.0 to 1.5
|
2.00 Hour
Interval 1.0 to 4.0
|
2.75 Hour
Interval 1.0 to 3.0
|
2.50 Hour
Interval 1.0 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected for this endpoint as it was incorrectly stated as one of the Secondary Endpoint in Objectives and Endpoints section of the Protocol, where the reference to Ctau for single ascending dose part was an error. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was planned to be presented in a single arm because of similar dosing strategies as pre-defined in the protocol.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=5 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=4 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=10 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Apparent Terminal Half-life (T1/2) After Single Dose Administration of GSK3186899
|
1.982 Hour
Interval 1.44 to 2.44
|
2.955 Hour
Interval 1.66 to 3.5
|
2.758 Hour
Interval 2.58 to 3.93
|
3.302 Hour
Interval 2.65 to 3.98
|
4.655 Hour
Interval 3.22 to 8.93
|
5.135 Hour
Interval 4.32 to 10.78
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Data for Part A: Cohorts 1 and 2- GSK3186899 300 mg arm was presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis of GSK3186899. Predicted accumulation ratio is calculated as 1/(1-e\^\[k\*tau\]) where k is elimination rate constant following the single dose and tau is the dosing interval for the intended repeat dosing.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
n=5 Participants
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
n=4 Participants
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
n=10 Participants
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=6 Participants
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 Participants
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Predicted Accumulation Ratio After Single Dose Administration of GSK3186899
|
1.0183 Ratio
Standard Deviation 0.01324
|
1.0631 Ratio
Standard Deviation 0.03952
|
1.0704 Ratio
Standard Deviation 0.04505
|
1.0889 Ratio
Standard Deviation 0.03246
|
1.2603 Ratio
Standard Deviation 0.19948
|
1.3429 Ratio
Standard Deviation 0.26138
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis of GSK3186899.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=22 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Dose-proportionality of GSK3186899 Administered as Single Dose Based on AUC(0-infinity)
|
1.47 Slope of log dose
Interval 1.34 to 1.61
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified time points were analyzed. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
Blood samples were collected at indicated time points for PK analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Outcome measures
| Measure |
Part A: Cohorts 1 and 2- GSK3186899 30 to 800 mg
n=22 Participants
Participants in Part A received a single dose of GSK3186899 30, 60, 120, 300, 600 and 800 mg in any of the treatment Periods of Cohorts 1 or 2 according to randomization schedule.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 6- GSK3186899 or Placebo
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part A: Cohort 1- GSK3186899 120 mg
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
|---|---|---|---|---|---|---|---|---|
|
Part A- Cohorts 1 and 2: Dose-proportionality of GSK3186899 Administered as Single Dose Based on Cmax
|
1.19 Slope of log dose
Interval 1.09 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose in each treatment periodPopulation: PK Population. Data was not collected as no participants were enrolled in Part A Cohort 3.
Blood samples were planned to be collected at indicated time points for PK analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dose; Days 2 to 9: Pre-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of AUC(0-tau) at Day 10 to AUC(0-tau) at Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of Cmax at Day 10 to Cmax at Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis. Accumulation ratio was planned to be calculated as ratio of Ctau at Day 10 to Ctau at Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 10: Pre-dose, 10, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours post-dosePopulation: PK Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for PK analysis. Time-invariance ratio was planned to be calculated as AUC(0-12) on Day 10 to AUC(0-infinity) on Day 1.
Outcome measures
Outcome data not reported
Adverse Events
Part A: Cohorts 1 and 2- Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Cohort 1- GSK3186899 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Cohort 1- GSK3186899 60 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 1- GSK3186899 120 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Cohorts 1 and 2- GSK3186899 300 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Cohort 2- GSK3186899 600 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 2- GSK3186899 800 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Cohort 2- GSK3186899 Dose Level 7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 4- GSK3186899 or Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 5- GSK3186899 or Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 6- GSK3186899 or Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Cohorts 1 and 2- Placebo
n=14 participants at risk
Participants in Part A Cohorts 1 and 2 received a single dose of placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part A: Cohort 1- GSK3186899 30 mg
n=6 participants at risk
Participants in Part A Cohort 1 received a single dose of GSK3186899 30 mg on Day 1 in treatment Period 1.
|
Part A: Cohort 1- GSK3186899 60 mg
n=6 participants at risk
Participants in Part A Cohort 1 received a single dose of GSK3186899 60 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 1- GSK3186899 120 mg
n=6 participants at risk
Participants in Part A Cohort 1 received a single dose of GSK3186899 120 mg on Day 1 in treatment Period 3.
|
Part A: Cohorts 1 and 2- GSK3186899 300 mg
n=12 participants at risk
Participants in Part A received a single dose of GSK3186899 300 mg on Day 1 in treatment Period 4 of Cohort 1 and treatment Period 1 of Cohort 2.
|
Part A: Cohort 2- GSK3186899 600 mg
n=6 participants at risk
Participants in Part A Cohort 2 received a single dose of GSK3186899 600 mg on Day 1 in treatment Period 2.
|
Part A: Cohort 2- GSK3186899 800 mg
n=6 participants at risk
Participants in Part A Cohort 2 received a single dose of GSK3186899 800 mg on Day 1 in treatment Period 3.
|
Part A: Cohort 2- GSK3186899 Dose Level 7
Participants in Part A Cohort 2 were planned to receive dose level 7 on Day 1 in treatment Period 4. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as the stopping criteria was reached with the 800mg dose and no further dose escalation was recommended.
|
Part A: Cohort 3- GSK3186899 (Fasted) + GSK3186899 (Fed)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part A: Cohort 3- GSK3186899 (Fed) + GSK3186899 (Fasted)
Participants in Part A Cohort 3 were planned to receive a single dose of GSK3186899 under fed conditions on Day 1 in treatment Period 1; followed by a single dose of GSK3186899 under fasted conditions on Day 1 in treatment Period 2. There was a planned washout period of 10 days between each treatment period.
|
Part B: Cohort 4- GSK3186899 or Placebo
Participants in Part B Cohort 4 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part B: Cohort 5- GSK3186899 or Placebo
Participants in Part B Cohort 5 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
Part B: Cohort 6- GSK3186899 or Placebo
Participants in Part B Cohort 6 were planned to receive repeat dose of GSK3186899 or placebo on Days 1 to 10.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
General disorders
Medical device site dermatitis
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
General disorders
Medical device site reaction
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
General disorders
Chest pain
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
8.3%
1/12 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Psychiatric disorders
Abnormal dreams
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/12 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
0.00%
0/6 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
—
0/0 • All-cause mortality, non-SAE and SAE were collected up to Week 12 in Part A. Data for Part A: Cohorts 1 and 2- Placebo and Part A: Cohorts 1 and 2- GSK3186899 300 mg arms were presented in a single arm because of similar dosing strategies as pre-defined in the protocol. Dose level 7 was not conducted as dose escalation was stopped at dose level 6 (800 mg), as stopping criteria was reached with 800 mg dose and no further dose escalation was recommended.
All-cause mortality,non-SAE,SAE were collected using Safety Population in Cohorts1and2 of PartA.1 participant from Enrolled Population(N=25) did not receive study treatment,hence was not included in Safety Population(N=24).Data was not collected in Cohort2-Period4,Cohort3 of PartA and PartB as study was terminated and no participant was enrolled in these cohorts/parts.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER