Trial Outcomes & Findings for Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin (NCT NCT04563845)
NCT ID: NCT04563845
Last Updated: 2023-12-06
Results Overview
Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.
COMPLETED
PHASE1
50 participants
Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7
2023-12-06
Participant Flow
This study was conducted at a single center in the United States.
A total of 50 participants (8 in Part 1 and 42 in Part 2) were enrolled in the study (Safety Population: It comprised of all participants who received at least 1 dose of study intervention).
Participant milestones
| Measure |
Part 1: Placebo
Participants received a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal.
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Part 1: GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
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Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg
Participants received a single therapeutic dose of GSK3640254 100 mg once daily on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg once daily on Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo
Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg/GSK3640254 500 mg
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg/GSK3640254 100 mg
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg
Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7(Treatment M). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Placebo/Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg/ Placebo
Participants received a single therapeutic dose of GSK3640254 100 mg Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo/GSK3640254 500 mg
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Placebo/GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 100 mg/Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg
Participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg/GSK3640254 100 mg
Participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg/Placebo
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
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Part 1: (Up to Day 9)
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Part 1: (Up to Day 9)
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Part 2:Washout Period 1(Up to 7 Days)
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Part 2:Treatment Period 2(Up to 7 Days)
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Part 2:Treatment Period 2(Up to 7 Days)
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Part 2:Treatment Period 2(Up to 7 Days)
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Part 2:Washout Period 2(Up to 7 Days)
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Part 2:Washout Period 2(Up to 7 Days)
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Part 2:Washout Period 2(Up to 7 Days)
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Part 2:Treatment Period 3(Up to 7 Days)
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Part 2:Treatment Period 3(Up to 7 Days)
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Part 2:Treatment Period 3(Up to 7 Days)
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Part 2:Washout Period 3(Up to 7 Days)
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Part 2:Washout Period 3(Up to 7 Days)
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Part 2:Washout Period 3(Up to 7 Days)
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Part 2:Treatment Period 4(Up to 7 Days)
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Part 2:Treatment Period 4(Up to 7 Days)
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Part 2:Treatment Period 4(Up to 7 Days)
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Reasons for withdrawal
| Measure |
Part 1: Placebo
Participants received a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal.
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Part 1: GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
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Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg
Participants received a single therapeutic dose of GSK3640254 100 mg once daily on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg once daily on Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo
Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg/GSK3640254 500 mg
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg/GSK3640254 100 mg
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg
Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7(Treatment M). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Placebo/Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg/ Placebo
Participants received a single therapeutic dose of GSK3640254 100 mg Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo/GSK3640254 500 mg
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Placebo/GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 100 mg/Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg
Participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg/GSK3640254 100 mg
Participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg/Placebo
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
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Part 2:Treatment Period 1(Up to 7 Days)
Adverse Event
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Part 2:Washout Period 1(Up to 7 Days)
Withdrawal by Subject
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Baseline Characteristics
Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin
Baseline characteristics by cohort
| Measure |
Part 1: Placebo
n=2 Participants
Participants received a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal.
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Part 1: GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
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Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg
n=3 Participants
Participants received a single therapeutic dose of GSK3640254 100 mg once daily on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg once daily on Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo
n=4 Participants
Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg/GSK3640254 500 mg
n=4 Participants
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
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Part 2: Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg/GSK3640254 100 mg
n=4 Participants
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
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Part 2: GSK3640254 500 mg/Placebo/GSK3640254 100 mg/Moxifloxacin 400 mg
n=4 Participants
Participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7(Treatment M). There was a washout period of at least 7 days between each treatment periods.
|
Part 2: Placebo/Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg
n=3 Participants
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
|
Part 2: GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg/ Placebo
n=3 Participants
Participants received a single therapeutic dose of GSK3640254 100 mg Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
|
Part 2: Moxifloxacin 400 mg/GSK3640254 100 mg/Placebo/GSK3640254 500 mg
n=3 Participants
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
|
Part 2: Placebo/GSK3640254 100 mg/GSK3640254 500 mg/Moxifloxacin 400 mg
n=4 Participants
Participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P) in treatment period 1. In treatment period 2, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 3, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). There was a washout period of at least 7 days between each treatment periods.
|
Part 2: GSK3640254 100 mg/Moxifloxacin 400 mg/Placebo/GSK3640254 500 mg
n=4 Participants
Participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 4, participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST). There was a washout period of at least 7 days between each treatment periods.
|
Part 2: GSK3640254 500 mg/Placebo/Moxifloxacin 400 mg/GSK3640254 100 mg
n=3 Participants
Participants received single supratherapeutic dose of GSK3640254 500 mg Days 1 through 7 (Treatment ST) in treatment period 1. In treatment period 2, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). In treatment period 3, participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M). In treatment period 4, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). There was a washout period of at least 7 days between each treatment periods.
|
Part 2: Moxifloxacin 400 mg/GSK3640254 500 mg/GSK3640254 100 mg/Placebo
n=3 Participants
Participants received placebo for GSK3640254 on Days 1 through 6 and a single dose of moxifloxacin 400 mg on Day 7 (Treatment M) in treatment period 1. In treatment period 2, participants received single supratherapeutic dose of GSK3640254 500 mg on Days 1 through 7 (Treatment ST). In treatment period 3, participants received a single therapeutic dose of GSK3640254 100 mg on Days 1 through 7 (Treatment T). In treatment period 4, participants received placebo for GSK3640254 on Days 1 through 7 (Treatment P). There was a washout period of at least 7 days between each treatment periods.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-50 years
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
4 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=8 Participants
|
50 Participants
n=16 Participants
|
|
Age, Customized
>50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=8 Participants
|
35 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
2 Participants
n=8 Participants
|
20 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
28 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7Population: Pharmacokinetic Parameter Population comprised of all participants who undergone plasma PK sampling and had evaluable PK parameters estimated. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254
|
102400 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254
|
68790 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) of GSK3640254
|
4439 Nanograms per milliliter
Geometric Coefficient of Variation 22.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254
|
2081 Nanograms per milliliter
Geometric Coefficient of Variation 32.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Time of Maximum Observed Concentration (Tmax) of GSK3640254
|
4.500 Hours
Interval 2.0 to 4.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7Population: Pharmacokinetic concentration Population comprised of all participants who undergone plasma PK sampling and had evaluable PK assay results. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Plasma Concentration of GSK3640254
12 Hour, Day 7
|
2773 Nanograms per milliliter
Standard Deviation 535.66
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
Pre-dose, Day 7
|
2168 Nanograms per milliliter
Standard Deviation 668.17
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
30 minutes, Day 7
|
2000 Nanograms per milliliter
Standard Deviation 638.53
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
1 Hour, Day 7
|
2579 Nanograms per milliliter
Standard Deviation 972.02
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
2 Hour, Day 7
|
3513 Nanograms per milliliter
Standard Deviation 1297.2
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
3 Hour, Day 7
|
4228 Nanograms per milliliter
Standard Deviation 997.39
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
3 Hours 30 minutes, Day 7
|
4155 Nanograms per milliliter
Standard Deviation 1042.5
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
4 Hour, Day 7
|
4213 Nanograms per milliliter
Standard Deviation 921.36
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
4 Hours 30 minutes, Day 7
|
4452 Nanograms per milliliter
Standard Deviation 916.01
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
5 Hour, Day 7
|
3840 Nanograms per milliliter
Standard Deviation 1299.8
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
6 Hour, Day 7
|
4010 Nanograms per milliliter
Standard Deviation 934.73
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
24 Hour, Day 7
|
2115 Nanograms per milliliter
Standard Deviation 640.77
|
—
|
—
|
—
|
|
Part 1: Plasma Concentration of GSK3640254
48 Hour, Day 7
|
1070 Nanograms per milliliter
Standard Deviation 412.36
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7Population: Pharmacokinetic concentration Population. Data was not collected for metabolites of GSK3640254 as there were not enough residual plasma left to analyze metabolites.
Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 9Population: Safety Population comprised of all randomized participants who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
Non SAE
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Baseline (Day -2)
|
143.5 Grams per liter
Standard Deviation 9.19
|
131.8 Grams per liter
Standard Deviation 15.65
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Day 3
|
149.5 Grams per liter
Standard Deviation 3.54
|
137.3 Grams per liter
Standard Deviation 15.81
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Day 7
|
151.5 Grams per liter
Standard Deviation 2.12
|
140.5 Grams per liter
Standard Deviation 18.51
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Hemoglobin
Day 9
|
152.0 Grams per liter
Standard Deviation 7.07
|
137.7 Grams per liter
Standard Deviation 15.82
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Hematocrit
Day 9
|
0.4465 Proportion of red blood cells in blood
Standard Deviation 0.01626
|
0.4062 Proportion of red blood cells in blood
Standard Deviation 0.03896
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Hematocrit
Baseline (Day -2)
|
0.4155 Proportion of red blood cells in blood
Standard Deviation 0.03041
|
0.3920 Proportion of red blood cells in blood
Standard Deviation 0.03663
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Hematocrit
Day 3
|
0.4365 Proportion of red blood cells in blood
Standard Deviation 0.00636
|
0.4048 Proportion of red blood cells in blood
Standard Deviation 0.03596
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Hematocrit
Day 7
|
0.4405 Proportion of red blood cells in blood
Standard Deviation 0.00636
|
0.4140 Proportion of red blood cells in blood
Standard Deviation 0.04358
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 3
|
87.30 Femtoliter
Standard Deviation 7.071
|
83.95 Femtoliter
Standard Deviation 5.315
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Baseline (Day -2)
|
87.70 Femtoliter
Standard Deviation 7.920
|
84.42 Femtoliter
Standard Deviation 5.398
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
|
87.30 Femtoliter
Standard Deviation 7.637
|
84.05 Femtoliter
Standard Deviation 4.980
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 9
|
88.20 Femtoliter
Standard Deviation 7.495
|
83.67 Femtoliter
Standard Deviation 4.815
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Baseline (Day-2)
|
30.35 Picograms
Standard Deviation 2.475
|
28.35 Picograms
Standard Deviation 2.299
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 3
|
29.85 Picograms
Standard Deviation 2.616
|
28.43 Picograms
Standard Deviation 2.417
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
|
30.00 Picograms
Standard Deviation 2.546
|
28.50 Picograms
Standard Deviation 2.269
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 9
|
30.00 Picograms
Standard Deviation 2.828
|
28.33 Picograms
Standard Deviation 2.087
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. .
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Baseline (Day -2)
|
2.520 10^9 cells per liter
Standard Deviation 0.2828
|
1.822 10^9 cells per liter
Standard Deviation 0.6201
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Day 3
|
4.300 10^9 cells per liter
Standard Deviation 3.8608
|
3.015 10^9 cells per liter
Standard Deviation 1.0263
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Day 7
|
4.205 10^9 cells per liter
Standard Deviation 3.6557
|
3.278 10^9 cells per liter
Standard Deviation 0.8286
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 9
|
239.0 10^9 cells per liter
Standard Deviation 82.02
|
269.8 10^9 cells per liter
Standard Deviation 74.88
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Baseline (Day -2)
|
0.375 10^9 cells per liter
Standard Deviation 0.0071
|
0.137 10^9 cells per liter
Standard Deviation 0.1166
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Day 3
|
0.350 10^9 cells per liter
Standard Deviation 0.1838
|
0.115 10^9 cells per liter
Standard Deviation 0.0794
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Day 7
|
0.345 10^9 cells per liter
Standard Deviation 0.2758
|
0.102 10^9 cells per liter
Standard Deviation 0.0804
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Baseline (Day -2)
|
0.070 10^9 cells per liter
Standard Deviation 0.0424
|
0.057 10^9 cells per liter
Standard Deviation 0.0163
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Day 3
|
0.065 10^9 cells per liter
Standard Deviation 0.0212
|
0.053 10^9 cells per liter
Standard Deviation 0.0186
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Day 7
|
0.065 10^9 cells per liter
Standard Deviation 0.0212
|
0.048 10^9 cells per liter
Standard Deviation 0.0160
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Day 9
|
0.060 10^9 cells per liter
Standard Deviation 0.0000
|
0.065 10^9 cells per liter
Standard Deviation 0.0176
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Day 9
|
0.330 10^9 cells per liter
Standard Deviation 0.2546
|
0.097 10^9 cells per liter
Standard Deviation 0.0833
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Day 3
|
2.715 10^9 cells per liter
Standard Deviation 0.5020
|
1.657 10^9 cells per liter
Standard Deviation 0.5352
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Day 7
|
2.515 10^9 cells per liter
Standard Deviation 0.1202
|
1.668 10^9 cells per liter
Standard Deviation 0.5780
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Day 9
|
2.100 10^9 cells per liter
Standard Deviation 0.0990
|
1.935 10^9 cells per liter
Standard Deviation 0.7973
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Baseline (Day -2)
|
0.550 10^9 cells per liter
Standard Deviation 0.1414
|
0.537 10^9 cells per liter
Standard Deviation 0.1878
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Day 3
|
0.570 10^9 cells per liter
Standard Deviation 0.1980
|
0.462 10^9 cells per liter
Standard Deviation 0.1253
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Day 7
|
0.525 10^9 cells per liter
Standard Deviation 0.0919
|
0.490 10^9 cells per liter
Standard Deviation 0.1685
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Day 9
|
0.490 10^9 cells per liter
Standard Deviation 0.1980
|
0.508 10^9 cells per liter
Standard Deviation 0.1411
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Baseline (Day -2)
|
4.010 10^9 cells per liter
Standard Deviation 3.3375
|
3.910 10^9 cells per liter
Standard Deviation 0.4029
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Day 9
|
5.215 10^9 cells per liter
Standard Deviation 5.1831
|
3.168 10^9 cells per liter
Standard Deviation 0.8168
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Baseline (Day -2)
|
228.0 10^9 cells per liter
Standard Deviation 50.91
|
266.5 10^9 cells per liter
Standard Deviation 83.32
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 3
|
233.0 10^9 cells per liter
Standard Deviation 59.40
|
264.2 10^9 cells per liter
Standard Deviation 75.68
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 7
|
243.5 10^9 cells per liter
Standard Deviation 68.59
|
280.0 10^9 cells per liter
Standard Deviation 72.09
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Baseline (Day -2)
|
7.35 10^9 cells per liter
Standard Deviation 3.606
|
6.47 10^9 cells per liter
Standard Deviation 1.025
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Day 3
|
8.00 10^9 cells per liter
Standard Deviation 4.384
|
5.30 10^9 cells per liter
Standard Deviation 1.499
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Day 7
|
7.65 10^9 cells per liter
Standard Deviation 3.606
|
5.58 10^9 cells per liter
Standard Deviation 1.466
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Day 9
|
8.15 10^9 cells per liter
Standard Deviation 5.020
|
5.75 10^9 cells per liter
Standard Deviation 1.738
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Baseline (Day -2)
|
4.740 10^12 cells per liter
Standard Deviation 0.0849
|
4.647 10^12 cells per liter
Standard Deviation 0.3336
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Day 7
|
5.060 10^12 cells per liter
Standard Deviation 0.3677
|
4.915 10^12 cells per liter
Standard Deviation 0.3246
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Day 3
|
5.010 10^12 cells per liter
Standard Deviation 0.3253
|
4.820 10^12 cells per liter
Standard Deviation 0.2626
|
—
|
—
|
|
Part 1: Absolute Values for Hematology Parameter: Erythrocytes
Day 9
|
5.065 10^12 cells per liter
Standard Deviation 0.2475
|
4.852 10^12 cells per liter
Standard Deviation 0.2556
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Day 3
|
6.0 Grams per liter
Standard Deviation 5.66
|
5.5 Grams per liter
Standard Deviation 6.95
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Day 7
|
8.0 Grams per liter
Standard Deviation 7.07
|
8.7 Grams per liter
Standard Deviation 8.29
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin
Day 9
|
8.5 Grams per liter
Standard Deviation 2.12
|
5.8 Grams per liter
Standard Deviation 10.30
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated timepoints to analyze hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Day 9
|
0.0310 Proportion of red blood cells in blood
Standard Deviation 0.01414
|
0.0142 Proportion of red blood cells in blood
Standard Deviation 0.03330
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Day 3
|
0.0210 Proportion of red blood cells in blood
Standard Deviation 0.02404
|
0.0128 Proportion of red blood cells in blood
Standard Deviation 0.01779
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Day 7
|
0.0250 Proportion of red blood cells in blood
Standard Deviation 0.02404
|
0.0220 Proportion of red blood cells in blood
Standard Deviation 0.02194
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 7
|
-0.40 Femtoliter
Standard Deviation 0.283
|
-0.37 Femtoliter
Standard Deviation 0.709
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 9
|
0.50 Femtoliter
Standard Deviation 0.424
|
-0.75 Femtoliter
Standard Deviation 0.802
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 3
|
-0.40 Femtoliter
Standard Deviation 0.849
|
-0.47 Femtoliter
Standard Deviation 0.403
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at idicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 3
|
-0.50 Picograms
Standard Deviation 0.141
|
0.08 Picograms
Standard Deviation 0.343
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 7
|
-0.35 Picograms
Standard Deviation 0.071
|
0.15 Picograms
Standard Deviation 0.501
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 9
|
-0.35 Picograms
Standard Deviation 0.354
|
-0.02 Picograms
Standard Deviation 0.412
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 3
|
5.0 10^9 cells per liter
Standard Deviation 8.49
|
-2.3 10^9 cells per liter
Standard Deviation 17.68
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Day 9
|
-0.060 10^9 cells per liter
Standard Deviation 0.0566
|
-0.028 10^9 cells per liter
Standard Deviation 0.0755
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Day 3
|
0.290 10^9 cells per liter
Standard Deviation 0.5233
|
-0.895 10^9 cells per liter
Standard Deviation 0.7988
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Day 7
|
0.195 10^9 cells per liter
Standard Deviation 0.3182
|
-0.632 10^9 cells per liter
Standard Deviation 0.5515
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Day 9
|
1.205 10^9 cells per liter
Standard Deviation 1.8455
|
-0.742 10^9 cells per liter
Standard Deviation 0.8588
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 7
|
15.5 10^9 cells per liter
Standard Deviation 17.68
|
13.5 10^9 cells per liter
Standard Deviation 29.49
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 9
|
11.0 10^9 cells per liter
Standard Deviation 31.11
|
3.3 10^9 cells per liter
Standard Deviation 36.74
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Day 3
|
0.65 10^9 cells per liter
Standard Deviation 0.778
|
-1.17 10^9 cells per liter
Standard Deviation 0.942
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Day 3
|
-0.005 10^9 cells per liter
Standard Deviation 0.0212
|
-0.003 10^9 cells per liter
Standard Deviation 0.0137
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Day 7
|
-0.005 10^9 cells per liter
Standard Deviation 0.0212
|
-0.008 10^9 cells per liter
Standard Deviation 0.0160
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Day 7
|
0.30 10^9 cells per liter
Standard Deviation 0.000
|
-0.88 10^9 cells per liter
Standard Deviation 0.818
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Day 9
|
-0.010 10^9 cells per liter
Standard Deviation 0.0424
|
0.008 10^9 cells per liter
Standard Deviation 0.0098
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Day 9
|
0.80 10^9 cells per liter
Standard Deviation 1.414
|
-0.72 10^9 cells per liter
Standard Deviation 1.011
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Day 3
|
-0.025 10^9 cells per liter
Standard Deviation 0.1909
|
-0.022 10^9 cells per liter
Standard Deviation 0.0462
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Day 7
|
-0.030 10^9 cells per liter
Standard Deviation 0.2828
|
-0.035 10^9 cells per liter
Standard Deviation 0.0497
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Day 9
|
-0.045 10^9 cells per liter
Standard Deviation 0.2616
|
-0.040 10^9 cells per liter
Standard Deviation 0.0559
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Day 3
|
0.195 10^9 cells per liter
Standard Deviation 0.2192
|
-0.165 10^9 cells per liter
Standard Deviation 0.2870
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Day 7
|
-0.005 10^9 cells per liter
Standard Deviation 0.1626
|
-0.153 10^9 cells per liter
Standard Deviation 0.3222
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Day 9
|
-0.420 10^9 cells per liter
Standard Deviation 0.3818
|
0.113 10^9 cells per liter
Standard Deviation 0.2908
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Day 3
|
0.020 10^9 cells per liter
Standard Deviation 0.0566
|
-0.075 10^9 cells per liter
Standard Deviation 0.0885
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Day 7
|
-0.025 10^9 cells per liter
Standard Deviation 0.0495
|
-0.047 10^9 cells per liter
Standard Deviation 0.1111
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Day 3
|
0.270 10^12 cells per liter
Standard Deviation 0.2404
|
0.173 10^12 cells per liter
Standard Deviation 0.2062
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Day 7
|
0.320 10^12 cells per liter
Standard Deviation 0.2828
|
0.268 10^12 cells per liter
Standard Deviation 0.2513
|
—
|
—
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes
Day 9
|
0.325 10^12 cells per liter
Standard Deviation 0.1626
|
0.205 10^12 cells per liter
Standard Deviation 0.3761
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Glucose, Day 9
|
4.635 Millimoles per liter
Standard Deviation 0.5162
|
4.605 Millimoles per liter
Standard Deviation 0.2660
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Cholesterol, Day 3
|
5.390 Millimoles per liter
Standard Deviation 1.1738
|
4.370 Millimoles per liter
Standard Deviation 0.5531
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Cholesterol, Day 7
|
5.180 Millimoles per liter
Standard Deviation 1.1031
|
4.413 Millimoles per liter
Standard Deviation 0.7692
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Magnesium, Baseline (Day -2)
|
0.760 Millimoles per liter
Standard Deviation 0.0283
|
0.767 Millimoles per liter
Standard Deviation 0.0413
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Magnesium, Day 9
|
0.800 Millimoles per liter
Standard Deviation 0.0283
|
0.813 Millimoles per liter
Standard Deviation 0.0301
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Triglycerides, Day 3
|
1.205 Millimoles per liter
Standard Deviation 0.1909
|
0.857 Millimoles per liter
Standard Deviation 0.2474
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Anion gap, Day 3
|
11.5 Millimoles per liter
Standard Deviation 2.12
|
9.5 Millimoles per liter
Standard Deviation 1.52
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Phosphate, Day 3
|
1.210 Millimoles per liter
Standard Deviation 0.0707
|
1.238 Millimoles per liter
Standard Deviation 0.0519
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Phosphate, Day 9
|
1.130 Millimoles per liter
Standard Deviation 0.0000
|
1.212 Millimoles per liter
Standard Deviation 0.1983
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Potassium, Day 3
|
4.00 Millimoles per liter
Standard Deviation 0.141
|
4.28 Millimoles per liter
Standard Deviation 0.232
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Sodium, Day 3
|
138.0 Millimoles per liter
Standard Deviation 1.41
|
136.5 Millimoles per liter
Standard Deviation 1.05
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Blood Urea Nitrogen, Baseline (Day -2)
|
4.300 Millimoles per liter
Standard Deviation 1.4425
|
4.482 Millimoles per liter
Standard Deviation 1.2674
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Calcium, Baseline (Day -2)
|
2.440 Millimoles per liter
Standard Deviation 0.0566
|
2.332 Millimoles per liter
Standard Deviation 0.0659
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Calcium, Day 3
|
2.430 Millimoles per liter
Standard Deviation 0.0000
|
2.370 Millimoles per liter
Standard Deviation 0.0930
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Glucose, Baseline (Day -2)
|
5.050 Millimoles per liter
Standard Deviation 0.3960
|
4.682 Millimoles per liter
Standard Deviation 0.3788
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Glucose, Day 3
|
4.495 Millimoles per liter
Standard Deviation 0.2333
|
4.745 Millimoles per liter
Standard Deviation 0.3566
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Glucose, Day 7
|
4.465 Millimoles per liter
Standard Deviation 0.1202
|
4.728 Millimoles per liter
Standard Deviation 0.3251
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Cholesterol, Baseline (Day-2)
|
5.025 Millimoles per liter
Standard Deviation 0.6576
|
4.112 Millimoles per liter
Standard Deviation 0.6916
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Cholesterol, Day 9
|
5.000 Millimoles per liter
Standard Deviation 0.9192
|
4.205 Millimoles per liter
Standard Deviation 0.8352
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Magnesium, Day 3
|
0.800 Millimoles per liter
Standard Deviation 0.0849
|
0.787 Millimoles per liter
Standard Deviation 0.0301
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Magnesium, Day 7
|
0.800 Millimoles per liter
Standard Deviation 0.0283
|
0.787 Millimoles per liter
Standard Deviation 0.0393
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Triglycerides, Baseline (Day -2)
|
1.295 Millimoles per liter
Standard Deviation 0.8839
|
0.763 Millimoles per liter
Standard Deviation 0.2595
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Triglycerides, Day 7
|
1.005 Millimoles per liter
Standard Deviation 0.2192
|
0.658 Millimoles per liter
Standard Deviation 0.2024
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Triglycerides, Day 9
|
0.965 Millimoles per liter
Standard Deviation 0.1626
|
0.615 Millimoles per liter
Standard Deviation 0.1946
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Anion gap, Baseline (Day-2)
|
12.5 Millimoles per liter
Standard Deviation 0.71
|
10.3 Millimoles per liter
Standard Deviation 1.51
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Anion gap, Day 7
|
10.0 Millimoles per liter
Standard Deviation 0.00
|
10.3 Millimoles per liter
Standard Deviation 1.03
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Anion gap, Day 9
|
11.0 Millimoles per liter
Standard Deviation 1.41
|
10.7 Millimoles per liter
Standard Deviation 1.75
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Calcium, Day 7
|
2.440 Millimoles per liter
Standard Deviation 0.0566
|
2.408 Millimoles per liter
Standard Deviation 0.1114
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Calcium, Day 9
|
2.390 Millimoles per liter
Standard Deviation 0.0566
|
2.337 Millimoles per liter
Standard Deviation 0.0843
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Carbon dioxide, Baseline (Day -2)
|
29.0 Millimoles per liter
Standard Deviation 1.41
|
28.7 Millimoles per liter
Standard Deviation 1.75
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Carbon dioxide, Day 3
|
30.0 Millimoles per liter
Standard Deviation 1.41
|
28.7 Millimoles per liter
Standard Deviation 2.16
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Carbon dioxide, Day 7
|
30.5 Millimoles per liter
Standard Deviation 0.71
|
29.2 Millimoles per liter
Standard Deviation 1.60
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Carbon dioxide, Day 9
|
30.0 Millimoles per liter
Standard Deviation 0.00
|
29.3 Millimoles per liter
Standard Deviation 2.25
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Chloride, Baseline (Day -2)
|
101.0 Millimoles per liter
Standard Deviation 2.83
|
103.7 Millimoles per liter
Standard Deviation 1.63
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Chloride, Day 3
|
100.5 Millimoles per liter
Standard Deviation 2.12
|
102.7 Millimoles per liter
Standard Deviation 1.75
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Chloride, Day 7
|
101.5 Millimoles per liter
Standard Deviation 0.71
|
102.2 Millimoles per liter
Standard Deviation 1.60
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Chloride, Day 9
|
102.5 Millimoles per liter
Standard Deviation 0.71
|
103.2 Millimoles per liter
Standard Deviation 1.17
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Phosphate, Baseline (Day -2)
|
1.195 Millimoles per liter
Standard Deviation 0.0919
|
1.142 Millimoles per liter
Standard Deviation 0.1443
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Phosphate, Day 7
|
1.195 Millimoles per liter
Standard Deviation 0.0495
|
1.223 Millimoles per liter
Standard Deviation 0.1203
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Potassium, Baseline (Day -2)
|
4.05 Millimoles per liter
Standard Deviation 0.071
|
4.10 Millimoles per liter
Standard Deviation 0.410
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Potassium, Day 7
|
4.35 Millimoles per liter
Standard Deviation 0.071
|
4.22 Millimoles per liter
Standard Deviation 0.133
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Potassium, Day 9
|
4.05 Millimoles per liter
Standard Deviation 0.071
|
4.20 Millimoles per liter
Standard Deviation 0.228
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Sodium, Baseline (Day -2)
|
138.5 Millimoles per liter
Standard Deviation 0.71
|
138.5 Millimoles per liter
Standard Deviation 1.64
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Sodium, Day 7
|
138.0 Millimoles per liter
Standard Deviation 0.00
|
137.7 Millimoles per liter
Standard Deviation 1.51
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Sodium, Day 9
|
139.5 Millimoles per liter
Standard Deviation 2.12
|
139.0 Millimoles per liter
Standard Deviation 0.89
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Blood Urea Nitrogen, Day 3
|
4.625 Millimoles per liter
Standard Deviation 1.2374
|
4.648 Millimoles per liter
Standard Deviation 0.6614
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Blood Urea Nitrogen, Day 7
|
5.230 Millimoles per liter
Standard Deviation 0.7778
|
4.690 Millimoles per liter
Standard Deviation 0.6622
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen
Blood Urea Nitrogen, Day 9
|
4.715 Millimoles per liter
Standard Deviation 0.4031
|
4.332 Millimoles per liter
Standard Deviation 0.7889
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALP, Day 7
|
75.0 International units per liter
Standard Deviation 26.87
|
54.8 International units per liter
Standard Deviation 16.22
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
AST, Day 3
|
24.5 International units per liter
Standard Deviation 12.02
|
17.5 International units per liter
Standard Deviation 2.35
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
AST, Day 9
|
18.0 International units per liter
Standard Deviation 5.66
|
17.5 International units per liter
Standard Deviation 3.99
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
GGT, Day 3
|
21.5 International units per liter
Standard Deviation 14.85
|
10.8 International units per liter
Standard Deviation 3.37
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
GGT, Day 7
|
20.0 International units per liter
Standard Deviation 14.14
|
12.0 International units per liter
Standard Deviation 3.29
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Creatine kinase, Day 3
|
64.5 International units per liter
Standard Deviation 24.75
|
91.2 International units per liter
Standard Deviation 69.29
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Lactate dehydrogenase, Day 7
|
142.0 International units per liter
Standard Deviation 22.63
|
115.8 International units per liter
Standard Deviation 22.05
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Lactate dehydrogenase, Day 9
|
133.0 International units per liter
Standard Deviation 24.04
|
114.5 International units per liter
Standard Deviation 26.10
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALT, Baseline (Day -2),
|
33.0 International units per liter
Standard Deviation 28.28
|
19.7 International units per liter
Standard Deviation 10.97
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALT, Day 3
|
37.5 International units per liter
Standard Deviation 33.23
|
16.8 International units per liter
Standard Deviation 7.94
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALT, Day 7
|
33.5 International units per liter
Standard Deviation 26.16
|
17.7 International units per liter
Standard Deviation 5.92
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
AST, Baseline (Day -2)
|
25.0 International units per liter
Standard Deviation 9.90
|
19.8 International units per liter
Standard Deviation 6.49
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALT, Day 9
|
28.5 International units per liter
Standard Deviation 23.33
|
18.2 International units per liter
Standard Deviation 8.75
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALP, Baseline (Day -2)
|
73.0 International units per liter
Standard Deviation 22.63
|
54.3 International units per liter
Standard Deviation 26.79
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALP, Day 3
|
76.5 International units per liter
Standard Deviation 23.33
|
50.0 International units per liter
Standard Deviation 15.05
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
ALP, Day 9
|
75.5 International units per liter
Standard Deviation 26.16
|
54.5 International units per liter
Standard Deviation 17.44
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
AST, Day 7
|
21.5 International units per liter
Standard Deviation 7.78
|
18.0 International units per liter
Standard Deviation 2.53
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
GGT, Baseline (Day -2)
|
21.0 International units per liter
Standard Deviation 14.14
|
11.0 International units per liter
Standard Deviation 3.22
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
GGT, Day 9
|
19.5 International units per liter
Standard Deviation 13.44
|
12.0 International units per liter
Standard Deviation 3.69
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Creatine kinase, Baseline (Day -2)
|
93.0 International units per liter
Standard Deviation 50.91
|
160.7 International units per liter
Standard Deviation 124.55
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Creatine kinase, Day 7
|
71.5 International units per liter
Standard Deviation 53.03
|
71.5 International units per liter
Standard Deviation 53.73
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Creatine kinase, Day 9
|
60.5 International units per liter
Standard Deviation 34.65
|
75.5 International units per liter
Standard Deviation 56.79
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Lactate dehydrogenase, Baseline (Day -2)
|
161.5 International units per liter
Standard Deviation 36.06
|
132.0 International units per liter
Standard Deviation 22.04
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase
Lactate dehydrogenase, Day 3
|
150.0 International units per liter
Standard Deviation 46.67
|
113.3 International units per liter
Standard Deviation 22.55
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, Day 9Population: Safety Population
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Direct Bilirubin, Day 7
|
1.60 Micromoles per liter
Standard Deviation 0.141
|
2.10 Micromoles per liter
Standard Deviation 1.016
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Direct Bilirubin, Day 9
|
1.55 Micromoles per liter
Standard Deviation 0.212
|
2.05 Micromoles per liter
Standard Deviation 0.862
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Creatinine, Baseline (Day -2)
|
89.75 Micromoles per liter
Standard Deviation 16.900
|
74.85 Micromoles per liter
Standard Deviation 15.104
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Creatinine, Day 3
|
83.10 Micromoles per liter
Standard Deviation 13.718
|
72.20 Micromoles per liter
Standard Deviation 8.322
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Creatinine, Day 7
|
86.60 Micromoles per liter
Standard Deviation 14.991
|
70.13 Micromoles per liter
Standard Deviation 8.411
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Creatinine, Day 9
|
85.30 Micromoles per liter
Standard Deviation 10.607
|
71.00 Micromoles per liter
Standard Deviation 8.919
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Urate, Baseline (Day -2)
|
363.0 Micromoles per liter
Standard Deviation 0.00
|
274.5 Micromoles per liter
Standard Deviation 72.37
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Urate, Day 3
|
351.0 Micromoles per liter
Standard Deviation 50.91
|
259.0 Micromoles per liter
Standard Deviation 61.48
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Urate, Day 7
|
365.5 Micromoles per liter
Standard Deviation 54.45
|
246.0 Micromoles per liter
Standard Deviation 60.52
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Urate, Day 9
|
348.0 Micromoles per liter
Standard Deviation 55.15
|
257.0 Micromoles per liter
Standard Deviation 59.67
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Direct Bilirubin, Day 3
|
1.45 Micromoles per liter
Standard Deviation 0.071
|
1.68 Micromoles per liter
Standard Deviation 0.571
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Total Bilirubin, Baseline (Day -2)
|
5.60 Micromoles per liter
Standard Deviation 1.697
|
7.00 Micromoles per liter
Standard Deviation 3.033
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Total Bilirubin, Day 3
|
8.55 Micromoles per liter
Standard Deviation 0.212
|
9.63 Micromoles per liter
Standard Deviation 3.059
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Total Bilirubin, Day 7
|
8.75 Micromoles per liter
Standard Deviation 0.212
|
11.33 Micromoles per liter
Standard Deviation 5.201
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Total Bilirubin, Day 9
|
7.80 Micromoles per liter
Standard Deviation 1.556
|
10.20 Micromoles per liter
Standard Deviation 5.043
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin
Direct Bilirubin, Baseline (Day -2)
|
0.95 Micromoles per liter
Standard Deviation 0.354
|
1.42 Micromoles per liter
Standard Deviation 0.605
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, Day 9Population: Safety Population
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Albumin, Day 3
|
46.0 Grams per liter
Standard Deviation 1.41
|
41.8 Grams per liter
Standard Deviation 3.31
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Albumin, Baseline (Day -2)
|
46.5 Grams per liter
Standard Deviation 2.12
|
43.0 Grams per liter
Standard Deviation 3.03
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Albumin, Day 7
|
47.5 Grams per liter
Standard Deviation 0.71
|
44.3 Grams per liter
Standard Deviation 3.61
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Albumin, Day 9
|
45.5 Grams per liter
Standard Deviation 0.71
|
43.2 Grams per liter
Standard Deviation 2.64
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Globulin, Baseline (Day -2)
|
26.5 Grams per liter
Standard Deviation 2.12
|
25.5 Grams per liter
Standard Deviation 5.13
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Globulin, Day 3
|
26.0 Grams per liter
Standard Deviation 0.00
|
27.7 Grams per liter
Standard Deviation 2.34
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Globulin, Day 7
|
25.0 Grams per liter
Standard Deviation 1.41
|
27.8 Grams per liter
Standard Deviation 3.66
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Globulin, Day 9
|
25.5 Grams per liter
Standard Deviation 0.71
|
27.5 Grams per liter
Standard Deviation 4.28
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Total protein, Baseline (Day -2)
|
73.0 Grams per liter
Standard Deviation 4.24
|
68.5 Grams per liter
Standard Deviation 5.47
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Total protein, Day 3
|
72.0 Grams per liter
Standard Deviation 1.41
|
69.5 Grams per liter
Standard Deviation 3.27
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Total protein, Day 7
|
72.5 Grams per liter
Standard Deviation 2.12
|
72.2 Grams per liter
Standard Deviation 4.07
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein
Total Bilirubin, Day 9
|
71.0 Grams per liter
Standard Deviation 1.41
|
70.7 Grams per liter
Standard Deviation 4.76
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Baseline (Day -2)
|
64.5 Units per liter
Standard Deviation 26.16
|
63.8 Units per liter
Standard Deviation 22.54
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Day 3
|
64.0 Units per liter
Standard Deviation 33.94
|
61.8 Units per liter
Standard Deviation 25.31
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Day 7
|
67.0 Units per liter
Standard Deviation 45.25
|
62.8 Units per liter
Standard Deviation 22.45
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Day 9
|
64.5 Units per liter
Standard Deviation 41.72
|
59.5 Units per liter
Standard Deviation 22.05
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Baseline (Day -2)
|
33.5 Units per liter
Standard Deviation 20.51
|
35.5 Units per liter
Standard Deviation 11.84
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Day 3
|
18.5 Units per liter
Standard Deviation 2.12
|
30.2 Units per liter
Standard Deviation 12.24
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Day 7
|
19.5 Units per liter
Standard Deviation 3.54
|
32.3 Units per liter
Standard Deviation 16.24
|
—
|
—
|
|
Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Day 9
|
18.5 Units per liter
Standard Deviation 3.54
|
29.3 Units per liter
Standard Deviation 11.29
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 7
|
1.5 Millimoles per liter
Standard Deviation 0.71
|
0.5 Millimoles per liter
Standard Deviation 0.84
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 3
|
1.0 Millimoles per liter
Standard Deviation 2.83
|
0.0 Millimoles per liter
Standard Deviation 2.00
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 3
|
-0.555 Millimoles per liter
Standard Deviation 0.6293
|
0.063 Millimoles per liter
Standard Deviation 0.3773
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 7
|
-0.585 Millimoles per liter
Standard Deviation 0.5162
|
0.047 Millimoles per liter
Standard Deviation 0.2914
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 9
|
-0.415 Millimoles per liter
Standard Deviation 0.9122
|
-0.077 Millimoles per liter
Standard Deviation 0.3626
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 3
|
0.365 Millimoles per liter
Standard Deviation 0.5162
|
0.258 Millimoles per liter
Standard Deviation 0.3570
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 7
|
0.155 Millimoles per liter
Standard Deviation 0.4455
|
0.302 Millimoles per liter
Standard Deviation 0.2662
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 9
|
-0.025 Millimoles per liter
Standard Deviation 0.2616
|
0.093 Millimoles per liter
Standard Deviation 0.2144
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 3
|
0.040 Millimoles per liter
Standard Deviation 0.0566
|
0.020 Millimoles per liter
Standard Deviation 0.0335
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 7
|
0.040 Millimoles per liter
Standard Deviation 0.0000
|
0.020 Millimoles per liter
Standard Deviation 0.0551
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 9
|
0.040 Millimoles per liter
Standard Deviation 0.0000
|
0.047 Millimoles per liter
Standard Deviation 0.0468
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 3
|
-0.090 Millimoles per liter
Standard Deviation 0.6930
|
0.093 Millimoles per liter
Standard Deviation 0.2432
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 7
|
-0.290 Millimoles per liter
Standard Deviation 0.6647
|
-0.105 Millimoles per liter
Standard Deviation 0.2076
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 9
|
-0.330 Millimoles per liter
Standard Deviation 0.7212
|
-0.148 Millimoles per liter
Standard Deviation 0.2494
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 3
|
-1.0 Millimoles per liter
Standard Deviation 1.41
|
-0.8 Millimoles per liter
Standard Deviation 1.60
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 7
|
-2.5 Millimoles per liter
Standard Deviation 0.71
|
0.0 Millimoles per liter
Standard Deviation 1.90
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 9
|
-1.5 Millimoles per liter
Standard Deviation 2.12
|
0.3 Millimoles per liter
Standard Deviation 2.50
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 3
|
-0.010 Millimoles per liter
Standard Deviation 0.0566
|
0.038 Millimoles per liter
Standard Deviation 0.0527
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 7
|
0.000 Millimoles per liter
Standard Deviation 0.1131
|
0.077 Millimoles per liter
Standard Deviation 0.0712
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 9
|
-0.050 Millimoles per liter
Standard Deviation 0.1131
|
0.005 Millimoles per liter
Standard Deviation 0.0558
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 9
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
0.7 Millimoles per liter
Standard Deviation 1.86
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 3
|
-0.5 Millimoles per liter
Standard Deviation 0.71
|
-1.0 Millimoles per liter
Standard Deviation 1.55
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 7
|
0.5 Millimoles per liter
Standard Deviation 2.12
|
-1.5 Millimoles per liter
Standard Deviation 1.97
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 9
|
1.5 Millimoles per liter
Standard Deviation 2.12
|
-0.5 Millimoles per liter
Standard Deviation 1.64
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 3
|
0.015 Millimoles per liter
Standard Deviation 0.1626
|
0.097 Millimoles per liter
Standard Deviation 0.1136
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 7
|
0.000 Millimoles per liter
Standard Deviation 0.1414
|
0.082 Millimoles per liter
Standard Deviation 0.1625
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 9
|
-0.065 Millimoles per liter
Standard Deviation 0.0919
|
0.070 Millimoles per liter
Standard Deviation 0.1898
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 3
|
-0.05 Millimoles per liter
Standard Deviation 0.071
|
0.18 Millimoles per liter
Standard Deviation 0.366
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 7
|
0.30 Millimoles per liter
Standard Deviation 0.141
|
0.12 Millimoles per liter
Standard Deviation 0.331
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 9
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
0.10 Millimoles per liter
Standard Deviation 0.363
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 3
|
-0.5 Millimoles per liter
Standard Deviation 0.71
|
-2.0 Millimoles per liter
Standard Deviation 1.90
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 7
|
-0.5 Millimoles per liter
Standard Deviation 0.71
|
-0.8 Millimoles per liter
Standard Deviation 2.04
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 9
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
0.5 Millimoles per liter
Standard Deviation 1.87
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 3
|
0.325 Millimoles per liter
Standard Deviation 0.2051
|
0.167 Millimoles per liter
Standard Deviation 1.4356
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 7
|
0.930 Millimoles per liter
Standard Deviation 0.6647
|
0.208 Millimoles per liter
Standard Deviation 1.5113
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 9
|
0.415 Millimoles per liter
Standard Deviation 1.0394
|
-0.150 Millimoles per liter
Standard Deviation 1.2510
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 3
|
4.5 International units per liter
Standard Deviation 4.95
|
-2.8 International units per liter
Standard Deviation 3.71
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 7
|
0.5 International units per liter
Standard Deviation 2.12
|
-2.0 International units per liter
Standard Deviation 9.70
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 9
|
-4.5 International units per liter
Standard Deviation 4.95
|
-1.5 International units per liter
Standard Deviation 12.77
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 3
|
3.5 International units per liter
Standard Deviation 0.71
|
-4.3 International units per liter
Standard Deviation 12.14
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 7
|
2.0 International units per liter
Standard Deviation 4.24
|
0.5 International units per liter
Standard Deviation 12.53
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 9
|
2.5 International units per liter
Standard Deviation 3.54
|
0.2 International units per liter
Standard Deviation 10.80
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 3
|
-0.5 International units per liter
Standard Deviation 2.12
|
-2.3 International units per liter
Standard Deviation 5.50
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 7
|
-3.5 International units per liter
Standard Deviation 2.12
|
-1.8 International units per liter
Standard Deviation 7.91
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 9
|
-7.0 International units per liter
Standard Deviation 4.24
|
-2.3 International units per liter
Standard Deviation 8.80
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 3
|
0.5 International units per liter
Standard Deviation 0.71
|
-0.2 International units per liter
Standard Deviation 1.17
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 7
|
-1.0 International units per liter
Standard Deviation 0.00
|
1.0 International units per liter
Standard Deviation 0.89
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 9
|
-1.5 International units per liter
Standard Deviation 0.71
|
1.0 International units per liter
Standard Deviation 0.89
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 3
|
-28.5 International units per liter
Standard Deviation 26.16
|
-69.5 International units per liter
Standard Deviation 104.08
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 7
|
-21.5 International units per liter
Standard Deviation 2.12
|
-89.2 International units per liter
Standard Deviation 121.90
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 9
|
-32.5 International units per liter
Standard Deviation 16.26
|
-85.2 International units per liter
Standard Deviation 127.35
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 3
|
-11.5 International units per liter
Standard Deviation 10.61
|
-18.7 International units per liter
Standard Deviation 9.27
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 7
|
-19.5 International units per liter
Standard Deviation 13.44
|
-16.2 International units per liter
Standard Deviation 9.99
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 9
|
-28.5 International units per liter
Standard Deviation 12.02
|
-17.5 International units per liter
Standard Deviation 19.41
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 9
|
-15.0 Micromoles per liter
Standard Deviation 55.15
|
-17.5 Micromoles per liter
Standard Deviation 23.86
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 9
|
-4.45 Micromoles per liter
Standard Deviation 6.293
|
-3.85 Micromoles per liter
Standard Deviation 10.095
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 3
|
-12.0 Micromoles per liter
Standard Deviation 50.91
|
-15.5 Micromoles per liter
Standard Deviation 33.59
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 7
|
2.5 Micromoles per liter
Standard Deviation 54.45
|
-28.5 Micromoles per liter
Standard Deviation 32.72
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 3
|
2.95 Micromoles per liter
Standard Deviation 1.909
|
2.63 Micromoles per liter
Standard Deviation 2.534
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 7
|
3.15 Micromoles per liter
Standard Deviation 1.485
|
4.33 Micromoles per liter
Standard Deviation 2.653
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 9
|
2.20 Micromoles per liter
Standard Deviation 0.141
|
3.20 Micromoles per liter
Standard Deviation 2.225
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 3
|
0.50 Micromoles per liter
Standard Deviation 0.283
|
0.27 Micromoles per liter
Standard Deviation 0.535
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 7
|
0.65 Micromoles per liter
Standard Deviation 0.212
|
0.68 Micromoles per liter
Standard Deviation 0.534
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 9
|
0.60 Micromoles per liter
Standard Deviation 0.141
|
0.63 Micromoles per liter
Standard Deviation 0.398
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 3
|
-6.65 Micromoles per liter
Standard Deviation 3.182
|
-2.65 Micromoles per liter
Standard Deviation 12.451
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 7
|
-3.15 Micromoles per liter
Standard Deviation 1.909
|
-4.72 Micromoles per liter
Standard Deviation 10.794
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Total Bilirubin, Day 9
|
-2.0 Grams per liter
Standard Deviation 5.66
|
2.2 Grams per liter
Standard Deviation 3.19
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Albumin, Day 3
|
-0.5 Grams per liter
Standard Deviation 3.54
|
-1.2 Grams per liter
Standard Deviation 0.75
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Albumin, Day 7
|
1.0 Grams per liter
Standard Deviation 2.83
|
1.3 Grams per liter
Standard Deviation 2.94
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Albumin, Day 9
|
-1.0 Grams per liter
Standard Deviation 2.83
|
0.2 Grams per liter
Standard Deviation 2.14
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Globulin, Day 3
|
-0.5 Grams per liter
Standard Deviation 2.12
|
2.2 Grams per liter
Standard Deviation 3.49
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Globulin, Day 7
|
-1.5 Grams per liter
Standard Deviation 3.54
|
2.3 Grams per liter
Standard Deviation 2.07
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Globulin, Day 9
|
-1.0 Grams per liter
Standard Deviation 2.83
|
2.0 Grams per liter
Standard Deviation 1.41
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Total protein, Day 3
|
-1.0 Grams per liter
Standard Deviation 5.66
|
1.0 Grams per liter
Standard Deviation 4.20
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein
Total protein, Day 7
|
-0.5 Grams per liter
Standard Deviation 6.36
|
3.7 Grams per liter
Standard Deviation 4.80
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase
Amylase, Day 3
|
-0.5 Units per liter
Standard Deviation 7.78
|
-2.0 Units per liter
Standard Deviation 8.72
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase
Lipase, Day 3
|
-15.0 Units per liter
Standard Deviation 18.38
|
-5.3 Units per liter
Standard Deviation 8.12
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase
Amylase, Day 7
|
2.5 Units per liter
Standard Deviation 19.09
|
-1.0 Units per liter
Standard Deviation 3.95
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase
Amylase, Day 9
|
0.0 Units per liter
Standard Deviation 15.56
|
-4.3 Units per liter
Standard Deviation 5.57
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase
Lipase, Day 7
|
-14.0 Units per liter
Standard Deviation 16.97
|
-3.2 Units per liter
Standard Deviation 7.73
|
—
|
—
|
|
Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase
Lipase, Day 9
|
-15.0 Units per liter
Standard Deviation 16.97
|
-6.2 Units per liter
Standard Deviation 4.31
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Baseline (Day -2)
|
1.0080 Ratio
Standard Deviation 0.00707
|
1.0092 Ratio
Standard Deviation 0.00574
|
—
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 3
|
1.0150 Ratio
Standard Deviation 0.00141
|
1.0125 Ratio
Standard Deviation 0.00565
|
—
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 7
|
1.0190 Ratio
Standard Deviation 0.00283
|
1.0167 Ratio
Standard Deviation 0.00450
|
—
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 9
|
1.0145 Ratio
Standard Deviation 0.00212
|
1.0097 Ratio
Standard Deviation 0.00557
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH)
Baseline (Day -2)
|
6.50 pH
Standard Deviation 0.707
|
7.08 pH
Standard Deviation 0.585
|
—
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH)
Day 3
|
6.50 pH
Standard Deviation 0.707
|
6.33 pH
Standard Deviation 0.606
|
—
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH)
Day 7
|
6.25 pH
Standard Deviation 0.354
|
6.25 pH
Standard Deviation 0.524
|
—
|
—
|
|
Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH)
Day 9
|
6.50 pH
Standard Deviation 0.707
|
6.25 pH
Standard Deviation 0.418
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 3
|
0.0070 Ratio
Standard Deviation 0.00566
|
0.0033 Ratio
Standard Deviation 0.00653
|
—
|
—
|
|
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 7
|
0.0110 Ratio
Standard Deviation 0.00424
|
0.0075 Ratio
Standard Deviation 0.00731
|
—
|
—
|
|
Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 9
|
0.0065 Ratio
Standard Deviation 0.00495
|
0.0005 Ratio
Standard Deviation 0.00912
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 3, Day 7, and Day 9Population: Safety Population
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Urinalysis Parameter: pH
Day 3
|
0.00 pH
Standard Deviation 1.414
|
-0.75 pH
Standard Deviation 0.612
|
—
|
—
|
|
Part 1: Change From Baseline in Urinalysis Parameter: pH
Day 7
|
-0.25 pH
Standard Deviation 1.061
|
-0.83 pH
Standard Deviation 0.408
|
—
|
—
|
|
Part 1: Change From Baseline in Urinalysis Parameter: pH
Day 9
|
0.00 pH
Standard Deviation 1.414
|
-0.83 pH
Standard Deviation 0.258
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline(Day-2), Day1: 2 Hours, 4 Hours, 6 Hours; Day 4: 2 Hours, 4 Hours, 6 Hours, Day 7: 2 Hours, 4 Hours, 6 Hours and Day 9Population: Safety Population
A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. 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 clinically significant abnormal 12-Lead ECG findings has reported
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 7: 4 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 7: 6 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Baseline (Day -2)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 1: 2 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 1: 4 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 1: 6 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 4: 2 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 4: 4 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 4: 6 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 7: 2 hours
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings
Day 9
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9Population: Safety Population
SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Baseline (Pre-dose, Day 1)
|
120.0 Millimeters (mm) of mercury
Standard Deviation 1.41
|
109.2 Millimeters (mm) of mercury
Standard Deviation 12.22
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 2
|
115.5 Millimeters (mm) of mercury
Standard Deviation 0.71
|
103.8 Millimeters (mm) of mercury
Standard Deviation 10.42
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 3
|
123.0 Millimeters (mm) of mercury
Standard Deviation 2.83
|
106.8 Millimeters (mm) of mercury
Standard Deviation 9.87
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 4
|
121.5 Millimeters (mm) of mercury
Standard Deviation 17.68
|
107.5 Millimeters (mm) of mercury
Standard Deviation 13.74
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 5
|
111.5 Millimeters (mm) of mercury
Standard Deviation 9.19
|
105.3 Millimeters (mm) of mercury
Standard Deviation 5.20
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 6
|
114.0 Millimeters (mm) of mercury
Standard Deviation 15.56
|
107.0 Millimeters (mm) of mercury
Standard Deviation 6.57
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 7
|
117.5 Millimeters (mm) of mercury
Standard Deviation 4.95
|
107.7 Millimeters (mm) of mercury
Standard Deviation 10.07
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 8
|
125.0 Millimeters (mm) of mercury
Standard Deviation 1.41
|
109.0 Millimeters (mm) of mercury
Standard Deviation 6.48
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Day 9
|
127.0 Millimeters (mm) of mercury
Standard Deviation 5.66
|
109.8 Millimeters (mm) of mercury
Standard Deviation 7.81
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Baseline (Pre-dose, Day 1)
|
74.0 Millimeters (mm) of mercury
Standard Deviation 4.24
|
61.5 Millimeters (mm) of mercury
Standard Deviation 8.22
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 2
|
70.5 Millimeters (mm) of mercury
Standard Deviation 4.95
|
59.8 Millimeters (mm) of mercury
Standard Deviation 5.74
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 3
|
76.0 Millimeters (mm) of mercury
Standard Deviation 5.66
|
59.7 Millimeters (mm) of mercury
Standard Deviation 3.14
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 4
|
66.0 Millimeters (mm) of mercury
Standard Deviation 14.14
|
64.0 Millimeters (mm) of mercury
Standard Deviation 9.90
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 5
|
69.5 Millimeters (mm) of mercury
Standard Deviation 21.92
|
62.3 Millimeters (mm) of mercury
Standard Deviation 5.57
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 6
|
65.5 Millimeters (mm) of mercury
Standard Deviation 12.02
|
61.2 Millimeters (mm) of mercury
Standard Deviation 4.49
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 7
|
72.0 Millimeters (mm) of mercury
Standard Deviation 11.31
|
63.7 Millimeters (mm) of mercury
Standard Deviation 5.79
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 8
|
67.0 Millimeters (mm) of mercury
Standard Deviation 8.49
|
64.5 Millimeters (mm) of mercury
Standard Deviation 9.65
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Day 9
|
69.5 Millimeters (mm) of mercury
Standard Deviation 9.19
|
64.7 Millimeters (mm) of mercury
Standard Deviation 7.50
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9Population: Safety Population
Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 3
|
70.5 Beats per minute (bpm)
Standard Deviation 2.12
|
65.0 Beats per minute (bpm)
Standard Deviation 10.24
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 7
|
70.0 Beats per minute (bpm)
Standard Deviation 7.07
|
70.5 Beats per minute (bpm)
Standard Deviation 7.50
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 8
|
70.0 Beats per minute (bpm)
Standard Deviation 8.49
|
81.3 Beats per minute (bpm)
Standard Deviation 9.63
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 9
|
73.0 Beats per minute (bpm)
Standard Deviation 2.83
|
67.8 Beats per minute (bpm)
Standard Deviation 9.02
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Baseline (Pre-dose, Day 1 )
|
70.5 Beats per minute (bpm)
Standard Deviation 7.78
|
67.8 Beats per minute (bpm)
Standard Deviation 13.44
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 2
|
63.0 Beats per minute (bpm)
Standard Deviation 7.07
|
68.7 Beats per minute (bpm)
Standard Deviation 10.60
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 4
|
71.0 Beats per minute (bpm)
Standard Deviation 5.66
|
68.8 Beats per minute (bpm)
Standard Deviation 12.29
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 5
|
67.0 Beats per minute (bpm)
Standard Deviation 14.14
|
72.5 Beats per minute (bpm)
Standard Deviation 12.32
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Pulse Rate
Day 6
|
66.5 Beats per minute (bpm)
Standard Deviation 3.54
|
67.2 Beats per minute (bpm)
Standard Deviation 8.57
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9Population: Safety Population
Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions.Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=2 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=6 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 2
|
36.10 Degrees Celsius
Standard Deviation 0.424
|
36.53 Degrees Celsius
Standard Deviation 0.225
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 3
|
36.10 Degrees Celsius
Standard Deviation 0.283
|
36.58 Degrees Celsius
Standard Deviation 0.264
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 4
|
36.15 Degrees Celsius
Standard Deviation 0.354
|
36.52 Degrees Celsius
Standard Deviation 0.479
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 9
|
36.35 Degrees Celsius
Standard Deviation 0.212
|
36.47 Degrees Celsius
Standard Deviation 0.234
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Baseline (Pre-dose, Day 1)
|
35.90 Degrees Celsius
Standard Deviation 0.424
|
36.50 Degrees Celsius
Standard Deviation 0.341
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 5
|
36.35 Degrees Celsius
Standard Deviation 0.354
|
36.58 Degrees Celsius
Standard Deviation 0.360
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 6
|
36.45 Degrees Celsius
Standard Deviation 0.354
|
36.47 Degrees Celsius
Standard Deviation 0.250
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 7
|
35.95 Degrees Celsius
Standard Deviation 0.495
|
36.47 Degrees Celsius
Standard Deviation 0.383
|
—
|
—
|
|
Part 1: Absolute Values for Vital Parameter: Temperature
Day 8
|
36.35 Degrees Celsius
Standard Deviation 0.071
|
36.63 Degrees Celsius
Standard Deviation 0.280
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose, Day 1) and up to Day 7Population: PK/QTc Population comprised of all participants who are in both QT/QTc and PK concentration Populations with at least 1 pair of post-dose PK and change from Baseline in QTc data from the same time point as well as participants in the QT/QTc Population who received placebo. Only those participants with data available at specified time points were analyzed. This outcome measure(OM) intended to provide Placebo-corrected data. Summary of change from Baseline data is provided in OM43.
Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as difference in model-predicted mean change from Baseline in QTcF between treatment groups using C-QTc analysis. A linear mixed-effects model with change from Baseline in QTcF as the dependent variable, time-matched GSK3640254 plasma concentration as a fixed effect, centered Baseline as additional covariate,treatment \&time as categorical factors, \& a random intercept \& slope per participant. In all calculations, concentrations in participants who received placebo were set to 0.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Using Concentration-QTc (C-QTc) Analysis
|
2.72 Milliseconds (ms)
Interval 2.04 to 3.39
|
11.49 Milliseconds (ms)
Interval 9.24 to 13.73
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment periodPopulation: Pharmacokinetic Concentration Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Plasma Concentration of GSK3640254
24 Hour, Day 7
|
469.9 Nanograms per milliliter
Standard Deviation 183.24
|
2257 Nanograms per milliliter
Standard Deviation 1127.6
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
Pre-dose, Day 7
|
496.0 Nanograms per milliliter
Standard Deviation 209.03
|
2357 Nanograms per milliliter
Standard Deviation 1137.1
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
30 minutes, Day 7
|
462.3 Nanograms per milliliter
Standard Deviation 188.61
|
2252 Nanograms per milliliter
Standard Deviation 1266.0
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
1 Hour, Day 7
|
486.6 Nanograms per milliliter
Standard Deviation 198.56
|
2339 Nanograms per milliliter
Standard Deviation 1289.3
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
2 Hour, Day 7
|
587.8 Nanograms per milliliter
Standard Deviation 298.21
|
2779 Nanograms per milliliter
Standard Deviation 1670.6
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
3 Hour, Day 7
|
682.4 Nanograms per milliliter
Standard Deviation 329.52
|
3372 Nanograms per milliliter
Standard Deviation 1757.9
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
3 Hours 30 minutes, Day 7
|
738.6 Nanograms per milliliter
Standard Deviation 368.38
|
3698 Nanograms per milliliter
Standard Deviation 1812.2
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
4 Hour, Day 7
|
765.5 Nanograms per milliliter
Standard Deviation 349.05
|
4011 Nanograms per milliliter
Standard Deviation 1880.5
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
4 Hours 30 minutes, Day 7
|
782.4 Nanograms per milliliter
Standard Deviation 318.09
|
4157 Nanograms per milliliter
Standard Deviation 1927.0
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
5 Hour, Day 7
|
811.3 Nanograms per milliliter
Standard Deviation 326.24
|
4172 Nanograms per milliliter
Standard Deviation 1804.9
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
6 Hour, Day 7
|
769.8 Nanograms per milliliter
Standard Deviation 265.82
|
4102 Nanograms per milliliter
Standard Deviation 1719.5
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
8 Hour, Day 7
|
740.9 Nanograms per milliliter
Standard Deviation 280.65
|
3762 Nanograms per milliliter
Standard Deviation 1727.0
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
10 Hour, Day 7
|
698.7 Nanograms per milliliter
Standard Deviation 280.28
|
3564 Nanograms per milliliter
Standard Deviation 1603.7
|
—
|
—
|
|
Part 2: Plasma Concentration of GSK3640254
12 Hour, Day 7
|
625.4 Nanograms per milliliter
Standard Deviation 231.50
|
3098 Nanograms per milliliter
Standard Deviation 1347.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment periodPopulation: Pharmacokinetic concentration Population. Data was not collected for metabolites of GSK3640254 as there were not enough residual plasma left to analyze metabolites.
Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population comprised of all participants in the safety population with measurements at baseline as well as on-treatment with at least 1 post-dose time point with a valid change from Baseline in QTc value. Only those participants with data available at specified time points were analyzed.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 3 Hour Post-dose
|
4.1 Beats per minute
Interval 2.44 to 5.76
|
5.6 Beats per minute
Interval 3.88 to 7.24
|
2.7 Beats per minute
Interval 1.01 to 4.32
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 3.5 Hour Post-dose
|
4.5 Beats per minute
Interval 2.86 to 6.15
|
6.0 Beats per minute
Interval 4.29 to 7.63
|
2.8 Beats per minute
Interval 1.15 to 4.47
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4 Hour Post-dose
|
3.7 Beats per minute
Interval 2.0 to 5.35
|
5.9 Beats per minute
Interval 4.22 to 7.62
|
2.6 Beats per minute
Interval 0.91 to 4.27
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 2 Hour Post-dose
|
5.9 Beats per minute
Interval 4.36 to 7.35
|
7.0 Beats per minute
Interval 5.47 to 8.51
|
4.5 Beats per minute
Interval 3.01 to 5.99
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4.5 Hour Post-dose
|
5.4 Beats per minute
Interval 3.43 to 7.41
|
6.9 Beats per minute
Interval 4.81 to 8.89
|
3.7 Beats per minute
Interval 1.65 to 5.66
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 5 Hour Post-dose
|
5.0 Beats per minute
Interval 3.38 to 6.68
|
7.5 Beats per minute
Interval 5.82 to 9.18
|
3.4 Beats per minute
Interval 1.77 to 5.08
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 6 Hour Post-dose
|
9.6 Beats per minute
Interval 7.68 to 11.58
|
12.7 Beats per minute
Interval 10.73 to 14.69
|
8.6 Beats per minute
Interval 6.64 to 10.56
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 0.5 Hour Post-dose
|
4.4 Beats per minute
Interval 2.62 to 6.15
|
8.5 Beats per minute
Interval 6.71 to 10.27
|
4.6 Beats per minute
Interval 2.87 to 6.39
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 1 Hour Post-dose
|
5.4 Beats per minute
Interval 3.7 to 7.06
|
9.1 Beats per minute
Interval 7.44 to 10.85
|
5.2 Beats per minute
Interval 3.51 to 6.86
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 8 Hour Post-dose
|
7.3 Beats per minute
Interval 5.56 to 9.11
|
10.5 Beats per minute
Interval 8.69 to 12.29
|
6.3 Beats per minute
Interval 4.46 to 8.06
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 10 Hour Post-dose
|
2.6 Beats per minute
Interval 0.93 to 4.31
|
7.0 Beats per minute
Interval 5.28 to 8.71
|
1.9 Beats per minute
Interval 0.16 to 3.57
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 12 Hour Post-dose
|
8.5 Beats per minute
Interval 6.74 to 10.31
|
9.2 Beats per minute
Interval 7.38 to 10.98
|
8.1 Beats per minute
Interval 6.27 to 9.9
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 24 Hour Post-dose
|
2.0 Beats per minute
Interval 0.29 to 3.8
|
3.3 Beats per minute
Interval 1.53 to 5.1
|
-0.6 Beats per minute
Interval -2.33 to 1.2
|
—
|
|
Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, Predose
|
0.0 Beats per minute
Interval -1.71 to 1.75
|
2.8 Beats per minute
Interval 1.03 to 4.56
|
0.3 Beats per minute
Interval -1.42 to 2.08
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated by subtracting Baseline value from post dose value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, Predose
|
4.2 Milliseconds
Interval 2.47 to 5.88
|
9.8 Milliseconds
Interval 8.08 to 11.59
|
2.7 Milliseconds
Interval 1.01 to 4.46
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 0.5 Hour Post-dose
|
-0.9 Milliseconds
Interval -2.76 to 1.03
|
5.3 Milliseconds
Interval 3.42 to 7.28
|
-1.9 Milliseconds
Interval -3.75 to 0.02
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 1 Hour Post-dose
|
0.4 Milliseconds
Interval -1.59 to 2.32
|
3.8 Milliseconds
Interval 1.79 to 5.8
|
-0.3 Milliseconds
Interval -2.22 to 1.68
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 2 Hour Post-dose
|
-2.2 Milliseconds
Interval -4.36 to -0.03
|
2.6 Milliseconds
Interval 0.35 to 4.8
|
-3.9 Milliseconds
Interval -6.09 to -1.76
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 3 Hour Post-dose
|
-2.8 Milliseconds
Interval -4.95 to -0.65
|
3.7 Milliseconds
Interval 1.55 to 5.95
|
-4.3 Milliseconds
Interval -6.48 to -2.18
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 3.5 Hour Post-dose
|
-2.9 Milliseconds
Interval -4.89 to -0.97
|
4.8 Milliseconds
Interval 2.82 to 6.84
|
-4.4 Milliseconds
Interval -6.33 to -2.38
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4 Hour Post-dose
|
-2.0 Milliseconds
Interval -3.9 to -0.17
|
5.6 Milliseconds
Interval 3.71 to 7.52
|
-3.0 Milliseconds
Interval -4.88 to -1.14
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4.5 Hour Post-dose
|
-1.5 Milliseconds
Interval -3.51 to 0.5
|
8.0 Milliseconds
Interval 5.95 to 10.08
|
-2.6 Milliseconds
Interval -4.57 to -0.53
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 5 Hour Post-dose
|
-1.1 Milliseconds
Interval -3.0 to 0.81
|
8.3 Milliseconds
Interval 6.35 to 10.26
|
-1.3 Milliseconds
Interval -3.19 to 0.64
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 6 Hour Post-dose
|
-1.2 Milliseconds
Interval -3.54 to 1.16
|
5.7 Milliseconds
Interval 3.3 to 8.1
|
-2.9 Milliseconds
Interval -5.25 to -0.52
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 8 Hour Post-dose
|
-8.5 Milliseconds
Interval -10.45 to -6.55
|
0.4 Milliseconds
Interval -1.58 to 2.41
|
-7.7 Milliseconds
Interval -9.67 to -5.7
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 10 Hour Post-dose
|
-4.0 Milliseconds
Interval -5.84 to -2.26
|
4.4 Milliseconds
Interval 2.59 to 6.26
|
-4.2 Milliseconds
Interval -6.05 to -2.4
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 12 Hour Post-dose
|
-1.5 Milliseconds
Interval -3.61 to 0.51
|
4.0 Milliseconds
Interval 1.88 to 6.06
|
-2.0 Milliseconds
Interval -4.12 to 0.1
|
—
|
|
Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 24 Hour Post-dose
|
-0.5 Milliseconds
Interval -2.5 to 1.42
|
7.1 Milliseconds
Interval 5.07 to 9.14
|
-0.6 Milliseconds
Interval -2.57 to 1.39
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 8 Hour Post-dose
|
-5.6 Milliseconds
Interval -9.06 to -2.11
|
-4.1 Milliseconds
Interval -7.61 to -0.62
|
-5.3 Milliseconds
Interval -8.76 to -1.76
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 10 Hour Post-dose
|
-3.9 Milliseconds
Interval -7.36 to -0.49
|
-3.9 Milliseconds
Interval -7.35 to -0.46
|
-5.0 Milliseconds
Interval -8.44 to -1.55
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, Predose
|
2.5 Milliseconds
Interval -1.09 to 6.1
|
3.1 Milliseconds
Interval -0.51 to 6.74
|
1.1 Milliseconds
Interval -2.56 to 4.66
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 0.5 Hour Post-dose
|
3.6 Milliseconds
Interval -0.05 to 7.23
|
5.7 Milliseconds
Interval 2.03 to 9.34
|
3.2 Milliseconds
Interval -0.42 to 6.84
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 1 Hour Post-dose
|
0.7 Milliseconds
Interval -2.82 to 4.31
|
-0.3 Milliseconds
Interval -3.86 to 3.3
|
-0.4 Milliseconds
Interval -3.97 to 3.14
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 2 Hour Post-dose
|
-3.6 Milliseconds
Interval -6.97 to -0.15
|
-1.2 Milliseconds
Interval -4.64 to 2.22
|
-2.8 Milliseconds
Interval -6.17 to 0.65
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 3 Hour Post-dose
|
-4.3 Milliseconds
Interval -7.79 to -0.76
|
-2.6 Milliseconds
Interval -6.18 to 0.89
|
-4.7 Milliseconds
Interval -8.2 to -1.16
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 3.5 Hour Post-dose
|
-3.9 Milliseconds
Interval -7.36 to -0.35
|
-1.5 Milliseconds
Interval -5.04 to 2.01
|
-4.7 Milliseconds
Interval -8.24 to -1.21
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4 Hour Post-dose
|
-3.4 Milliseconds
Interval -6.82 to 0.05
|
-2.9 Milliseconds
Interval -6.38 to 0.53
|
-4.6 Milliseconds
Interval -8.06 to -1.17
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4.5 Hour Post-dose
|
-4.7 Milliseconds
Interval -8.21 to -1.16
|
-4.3 Milliseconds
Interval -7.82 to -0.72
|
-5.3 Milliseconds
Interval -8.88 to -1.81
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 5 Hour Post-dose
|
-3.9 Milliseconds
Interval -7.36 to -0.44
|
-3.7 Milliseconds
Interval -7.15 to -0.18
|
-3.9 Milliseconds
Interval -7.41 to -0.47
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 6 Hour Post-dose
|
-3.8 Milliseconds
Interval -7.37 to -0.27
|
-3.9 Milliseconds
Interval -7.43 to 0.29
|
-4.1 Milliseconds
Interval -7.61 to -0.5
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 12 Hour Post-dose
|
-3.0 Milliseconds
Interval -6.46 to 0.39
|
-1.8 Milliseconds
Interval -5.23 to 1.63
|
-3.6 Milliseconds
Interval -7.05 to -0.17
|
—
|
|
Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 24 Hour Post-dose
|
-0.5 Milliseconds
Interval -3.99 to 2.92
|
-0.9 Milliseconds
Interval -4.4 to 2.57
|
0.9 Milliseconds
Interval -2.56 to 4.38
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 1 Hour Post-dose
|
0.5 Milliseconds
Interval -0.05 to 0.98
|
0.8 Milliseconds
Interval 0.28 to 1.33
|
0.1 Milliseconds
Interval -0.4 to 0.64
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, 3 Hour Post-dose
|
0.6 Milliseconds
Interval 0.11 to 1.14
|
0.5 Milliseconds
Interval -0.01 to 1.04
|
0.1 Milliseconds
Interval -0.42 to 0.61
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4 Hour Post-dose
|
0.9 Milliseconds
Interval 0.38 to 1.49
|
1.1 Milliseconds
Interval 0.57 to 1.7
|
0.6 Milliseconds
Interval 0.07 to 1.18
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 10 Hour Post-dose
|
1.1 Milliseconds
Interval 0.48 to 1.66
|
1.2 Milliseconds
Interval 0.61 to 1.82
|
0.6 Milliseconds
Interval -0.01 to 1.19
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 24 Hour Post-dose
|
0.4 Milliseconds
Interval -0.26 to 1.06
|
0.9 Milliseconds
Interval 0.22 to 1.58
|
-0.5 Milliseconds
Interval -1.13 to 0.2
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day 7, Predose
|
0.5 Milliseconds
Interval -0.07 to 1.0
|
1.0 Milliseconds
Interval 0.44 to 1.54
|
0.4 Milliseconds
Interval -0.16 to 0.92
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 0.5 Hour Post-dose
|
0.7 Milliseconds
Interval 0.19 to 1.27
|
1.1 Milliseconds
Interval 0.52 to 1.62
|
0.5 Milliseconds
Interval -0.02 to 1.06
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 2 Hour Post-dose
|
0.4 Milliseconds
Interval -0.17 to 0.88
|
0.6 Milliseconds
Interval 0.05 to 1.12
|
-0.1 Milliseconds
Interval -0.64 to 0.41
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 3.5 Hour Post-dose
|
0.6 Milliseconds
Interval 0.07 to 1.2
|
0.9 Milliseconds
Interval 0.34 to 1.48
|
0.3 Milliseconds
Interval -0.27 to 0.86
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 4.5 Hour Post-dose
|
1.1 Milliseconds
Interval 0.51 to 1.63
|
1.3 Milliseconds
Interval 0.69 to 1.84
|
0.9 Milliseconds
Interval 0.32 to 1.44
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 5 Hour Post-dose
|
1.3 Milliseconds
Interval 0.66 to 1.85
|
1.5 Milliseconds
Interval 0.85 to 2.07
|
1.0 Milliseconds
Interval 0.42 to 1.62
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 6 Hour Post-dose
|
1.3 Milliseconds
Interval 0.62 to 1.97
|
1.3 Milliseconds
Interval 0.66 to 2.02
|
1.2 Milliseconds
Interval 0.51 to 1.85
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 8 Hour Post-dose
|
0.5 Milliseconds
Interval -0.14 to 1.14
|
0.9 Milliseconds
Interval 0.24 to 1.54
|
0.2 Milliseconds
Interval -0.43 to 0.86
|
—
|
|
Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms
Day7, 12 Hour Post-dose
|
0.8 Milliseconds
Interval 0.2 to 1.39
|
0.7 Milliseconds
Interval 0.09 to 1.29
|
0.2 Milliseconds
Interval -0.36 to 0.83
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 43.
Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as model-predicted mean change from Baseline in QTcF in GSK3640254 group minus model-predicted mean change from Baseline in QTcF in the placebo group (by-time point analysis). Time point analysis was performed based on a linear mixed-effects model: Change from Baseline in QTcF = Time + Treatment + Time\*Treatment +Baseline QTcF + Period + Sequence. An unstructured covariance structure was used to specify the repeated measures (time within participant and period). A random intercept per participant was also included.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 3 Hour Post-dose
|
1.5 Milliseconds
Interval -1.45 to 4.51
|
8.1 Milliseconds
Interval 5.06 to 11.09
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 4.5 Hour Post-dose
|
1.0 Milliseconds
Interval -1.73 to 3.82
|
10.6 Milliseconds
Interval 7.75 to 13.38
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 5 Hour Post-dose
|
0.2 Milliseconds
Interval -2.44 to 2.8
|
9.6 Milliseconds
Interval 6.92 to 12.24
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 6 Hour Post-dose
|
1.7 Milliseconds
Interval -1.58 to 4.97
|
8.6 Milliseconds
Interval 5.27 to 11.89
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 8 Hour Post-dose
|
-0.8 Milliseconds
Interval -3.54 to 1.9
|
8.1 Milliseconds
Interval 5.34 to 10.85
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 10 Hour Post-dose
|
0.2 Milliseconds
Interval -2.3 to 2.65
|
8.6 Milliseconds
Interval 6.14 to 11.15
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 12 Hour Post-dose
|
0.5 Milliseconds
Interval -2.43 to 3.35
|
6.0 Milliseconds
Interval 3.07 to 8.89
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 24 Hour Post-dose
|
0.1 Milliseconds
Interval -2.66 to 2.76
|
7.7 Milliseconds
Interval 4.94 to 10.45
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, Predose
|
1.4 Milliseconds
Interval -0.88 to 3.77
|
7.1 Milliseconds
Interval 4.74 to 9.46
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 0.5 Hour Post-dose
|
1.0 Milliseconds
Interval -1.6 to 3.59
|
7.2 Milliseconds
Interval 4.59 to 9.83
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 1 Hour Post-dose
|
0.6 Milliseconds
Interval -2.06 to 3.33
|
4.1 Milliseconds
Interval 1.34 to 6.79
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 2 Hour Post-dose
|
1.7 Milliseconds
Interval -1.27 to 4.73
|
6.5 Milliseconds
Interval 3.46 to 9.55
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 3.5 Hour Post-dose
|
1.4 Milliseconds
Interval -1.3 to 4.13
|
9.2 Milliseconds
Interval 6.44 to 11.93
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis
Day7, 4 Hour Post-dose
|
1.0 Milliseconds
Interval -1.59 to 3.54
|
8.6 Milliseconds
Interval 6.03 to 11.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 42.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in HR was calculated as model-predicted mean change from Baseline in HR in GSK3640254 group minus model-predicted mean change from Baseline in HR in the placebo group.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, Predose
|
-0.3 Beats per minute
Interval -2.19 to 1.58
|
2.5 Beats per minute
Interval 0.55 to 4.39
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 0.5 Hour Post-dose
|
-0.2 Beats per minute
Interval -2.17 to 1.67
|
3.9 Beats per minute
Interval 1.92 to 5.8
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 1 Hour Post-dose
|
0.2 Beats per minute
Interval -1.57 to 1.96
|
4.0 Beats per minute
Interval 2.17 to 5.75
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 4.5 Hour Post-dose
|
1.8 Beats per minute
Interval -0.58 to 4.11
|
3.2 Beats per minute
Interval 0.8 to 5.58
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 3 Hour Post-dose
|
1.4 Beats per minute
Interval -0.29 to 3.16
|
2.9 Beats per minute
Interval 1.15 to 4.65
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 3.5 Hour Post-dose
|
1.7 Beats per minute
Interval -0.02 to 3.42
|
3.2 Beats per minute
Interval 1.41 to 4.9
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 4 Hour Post-dose
|
1.1 Beats per minute
Interval -0.68 to 2.86
|
3.3 Beats per minute
Interval 1.54 to 5.12
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 5 Hour Post-dose
|
1.6 Beats per minute
Interval -0.11 to 3.32
|
4.1 Beats per minute
Interval 2.33 to 5.82
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 6 Hour Post-dose
|
1.0 Beats per minute
Interval -1.24 to 3.3
|
4.1 Beats per minute
Interval 1.81 to 6.41
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 8 Hour Post-dose
|
1.1 Beats per minute
Interval -0.9 to 3.05
|
4.2 Beats per minute
Interval 2.23 to 6.23
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 10 Hour Post-dose
|
0.8 Beats per minute
Interval -1.05 to 2.57
|
5.1 Beats per minute
Interval 3.3 to 6.97
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 12 Hour Post-dose
|
0.4 Beats per minute
Interval -1.56 to 2.44
|
1.1 Beats per minute
Interval -0.92 to 3.11
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 24 Hour Post-dose
|
2.6 Beats per minute
Interval 0.7 to 4.53
|
3.9 Beats per minute
Interval 1.93 to 5.84
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 2 Hour Post-dose
|
1.4 Beats per minute
Interval -0.03 to 2.73
|
2.5 Beats per minute
Interval 1.08 to 3.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at the specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 44.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in PR was calculated as model-predicted mean change from Baseline in PR interval in GSK3640254 group minus model-predicted mean change from Baseline in PR interval in the placebo group.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, Predose
|
1.5 Milliseconds
Interval -1.17 to 4.08
|
2.1 Milliseconds
Interval -0.61 to 4.73
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 0.5 Hour Post-dose
|
0.4 Milliseconds
Interval -2.33 to 3.1
|
2.5 Milliseconds
Interval -0.27 to 5.22
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 1 Hour Post-dose
|
1.2 Milliseconds
Interval -1.31 to 3.63
|
0.1 Milliseconds
Interval -2.37 to 2.63
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 2 Hour Post-dose
|
-0.8 Milliseconds
Interval -2.76 to 1.15
|
1.6 Milliseconds
Interval -0.44 to 3.54
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 3 Hour Post-dose
|
0.4 Milliseconds
Interval -1.93 to 2.74
|
2.0 Milliseconds
Interval -0.33 to 4.4
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 4 Hour Post-dose
|
1.2 Milliseconds
Interval -0.84 to 3.3
|
1.7 Milliseconds
Interval -0.42 to 3.79
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 4.5 Hour Post-dose
|
0.7 Milliseconds
Interval -1.72 to 3.04
|
1.1 Milliseconds
Interval -1.35 to 3.5
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 5 Hour Post-dose
|
0.0 Milliseconds
Interval -2.12 to 2.2
|
0.3 Milliseconds
Interval -1.93 to 2.47
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 6 Hour Post-dose
|
0.2 Milliseconds
Interval -2.22 to 2.7
|
0.2 Milliseconds
Interval -2.3 to 2.69
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 8 Hour Post-dose
|
-0.3 Milliseconds
Interval -2.57 to 1.91
|
1.1 Milliseconds
Interval -1.13 to 3.41
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 10 Hour Post-dose
|
1.1 Milliseconds
Interval -1.0 to 3.13
|
1.1 Milliseconds
Interval -1.0 to 3.18
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 12 Hour Post-dose
|
0.6 Milliseconds
Interval -1.46 to 2.61
|
1.8 Milliseconds
Interval -0.24 to 3.86
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 24 Hour Post-dose
|
-1.4 Milliseconds
Interval -3.58 to 0.69
|
-1.8 Milliseconds
Interval -4.0 to 0.36
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 3.5 Hour Post-dose
|
0.9 Milliseconds
Interval -1.44 to 3.2
|
3.2 Milliseconds
Interval 0.86 to 5.57
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at the specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 45.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QRS was calculated as model-predicted mean change from Baseline in QRS interval in GSK3640254 group minus model-predicted mean change from Baseline in QRS interval in the placebo group.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, Predose
|
0.1 Milliseconds
Interval -0.66 to 0.83
|
0.6 Milliseconds
Interval -0.14 to 1.37
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 0.5 Hour Post-dose
|
0.2 Milliseconds
Interval -0.54 to 0.95
|
0.5 Milliseconds
Interval -0.21 to 1.3
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 1 Hour Post-dose
|
0.3 Milliseconds
Interval -0.37 to 1.06
|
0.7 Milliseconds
Interval -0.04 to 1.41
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 2 Hour Post-dose
|
0.5 Milliseconds
Interval -0.26 to 1.2
|
0.7 Milliseconds
Interval -0.04 to 1.44
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 3 Hour Post-dose
|
0.5 Milliseconds
Interval -0.18 to 1.24
|
0.4 Milliseconds
Interval -0.29 to 1.15
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 3.5 Hour Post-dose
|
0.3 Milliseconds
Interval -0.44 to 1.12
|
0.6 Milliseconds
Interval -0.17 to 1.4
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 4 Hour Post-dose
|
0.3 Milliseconds
Interval -0.46 to 1.08
|
0.5 Milliseconds
Interval -0.26 to 1.29
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 4.5 Hour Post-dose
|
0.2 Milliseconds
Interval -0.59 to 0.97
|
0.4 Milliseconds
Interval -0.4 to 1.18
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 5 Hour Post-dose
|
0.2 Milliseconds
Interval -0.6 to 1.06
|
0.4 Milliseconds
Interval -0.4 to 1.28
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 6 Hour Post-dose
|
0.1 Milliseconds
Interval -0.82 to 1.06
|
0.2 Milliseconds
Interval -0.79 to 1.11
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 8 Hour Post-dose
|
0.3 Milliseconds
Interval -0.61 to 1.18
|
0.7 Milliseconds
Interval -0.23 to 1.58
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 10 Hour Post-dose
|
0.5 Milliseconds
Interval -0.35 to 1.31
|
0.6 Milliseconds
Interval -0.21 to 1.47
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 12 Hour Post-dose
|
0.6 Milliseconds
Interval -0.27 to 1.39
|
0.5 Milliseconds
Interval -0.38 to 1.29
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Day7, 24 Hour Post-dose
|
0.9 Milliseconds
Interval -0.06 to 1.79
|
1.4 Milliseconds
Interval 0.43 to 2.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 51Population: QT/QTc Population. Only those participants with data available at the specified time points were analyzed.
Twelve-lead ECGs were recorded using an automated ECG machine with participant in a supine position after a rest of at least 10 minutes. Number of participants with outlier results for HR, QTcF, ΔQTcF, PR interval and QRS interval were summarized.Categorical outlier criteria was as follows:change from Baseline in QTcF (ΔQTcF) \>60 ms: Increase of QTc from Baseline \> 60 ms, QTcF \> 500 ms:Treatment-emergent value of \> 500 ms when not present at Baseline (new onset), HR \< 50 bpm with a decrease in change from Baseline in heart rate (ΔHR) \> 25%:Decrease of HR from Baseline \>25% resulting in HR \< 50 bpm, HR \> 100 bpm with an increase in ΔHR \> 25% :Increase of HR from Baseline \>25% resulting in HR \> 100 bpm, PR \> 200 ms with an increase in change from Baseline in PR interval (ΔPR) \> 25%:Increase of PR from Baseline \> 25% resulting in PR \> 200 ms, QRS \> 120 ms with an increase in change from Baseline in QRS interval (ΔQRS) \> 25%:Increase of QRS from Baseline \> 25% resulting in QRS \> 120 ms.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg
ΔQTcF >60 ms
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg
QTcF >500 ms
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg
HR <50 bpm with a decrease in ΔHR > 25%
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg
HR >100 bpm with an increase in ΔHR > 25%
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg
PR >200 ms with an increase in ΔPR > 25%
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg
QRS >120 ms an increase in ΔQRS > 25%
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 51Population: QT/QTc Population. Only those participants with data available at the specified time points were analyzed.
Twelve-lead ECGs were recorded using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Flat T-wave=T-amplitude \< 1 mm (either positive \[+\] or negative \[-\]), including flat isoelectric line, Notched T-wave (+)=Presence of notch(es) of at least 0.05 millivolt (mV) amplitude on ascending or descending arm of the positive T-wave, Biphasic= T-wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T-waves included), Normal T-wave (-)=T-amplitude that is negative, without biphasic T-wave or notches, Notched T-wave (-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T-wave, U-waves= Presence of abnormal U-waves. Data has been reported for Flat T-wave, Notched T-wave (Positive), Biphasic, Normal T-wave (Negative), Notched T-wave (Negative) and T-U wave Fusion.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=39 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Notched T-wave (Positive)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Biphasic
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Normal T-wave (Negative)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Notched T-wave (Negative)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
T-U wave Fusion
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg
Flat T-wave
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at specified time points were analyzed. This outcome measure is intended to provide Placebo-corrected data. Placebo and treatment wise change from Baseline data is provided in outcome measure number 91.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QTcF was calculated as model-predicted mean change from Baseline in QTcF in moxifloxacin group minus model-predicted mean change from Baseline in QTcF in the placebo group.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day 7, Predose
|
0.6 Milliseconds
Interval -1.74 to 2.9
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day 7, 1 Hour Post-dose
|
-0.8 Milliseconds
Interval -3.5 to 1.88
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 2 Hour Post-dose
|
5.6 Milliseconds
Interval 2.57 to 8.61
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day 7, 3 Hour Post-dose
|
7.9 Milliseconds
Interval 4.94 to 10.92
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 3.5 Hour Post-dose
|
8.9 Milliseconds
Interval 6.15 to 11.6
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 4 Hour Post-dose
|
8.6 Milliseconds
Interval 6.07 to 11.21
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 5 Hour Post-dose
|
8.2 Milliseconds
Interval 5.53 to 10.79
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 10 Hour Post-dose
|
6.8 Milliseconds
Interval 4.3 to 9.28
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 12 Hour Post-dose
|
5.3 Milliseconds
Interval 2.38 to 8.17
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 24 Hour Post-dose
|
6.8 Milliseconds
Interval 4.13 to 9.54
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 0.5 Hour Post-dose
|
-0.2 Milliseconds
Interval -2.82 to 2.37
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 4.5 Hour Post-dose
|
8.4 Milliseconds
Interval 5.62 to 11.18
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 6 Hour Post-dose
|
8.2 Milliseconds
Interval 4.94 to 11.5
|
—
|
—
|
—
|
|
Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin
Day7, 8 Hour Post-dose
|
6.9 Milliseconds
Interval 4.19 to 9.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment PeriodPopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods .
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: AUC(0-t) of GSK3640254 100 mg and GSK3640254 500 mg
|
13840 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.2
|
67520 Hours*nanograms per milliliter
Geometric Coefficient of Variation 42.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment PeriodPopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: AUC(0-tau) of GSK3640254 100 mg and GSK3640254 500 mg
|
13830 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.2
|
67490 Hours*nanograms per milliliter
Geometric Coefficient of Variation 42.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment PeriodPopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Cmax of GSK3640254 100 mg and GSK3640254 500 mg
|
830.3 Nanograms per milliliter
Geometric Coefficient of Variation 37.9
|
4261 Nanograms per milliliter
Geometric Coefficient of Variation 41.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment PeriodPopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Ctau of GSK3640254 100 mg and GSK3640254 500 mg
|
459.9 Nanograms per milliliter
Geometric Coefficient of Variation 40.3
|
2137 Nanograms per milliliter
Geometric Coefficient of Variation 46.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment PeriodPopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Tmax of GSK3640254 100 mg and GSK3640254 500 mg
|
5.008 Hours
Interval 2.07 to 12.0
|
5.000 Hours
Interval 2.0 to 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment periodPopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Cmax of Moxifloxacin 400 mg
|
1964 Nanograms per milliliter
Geometric Coefficient of Variation 20.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment periodPopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Tmax of Moxifloxacin 400 mg
|
4.000 Hours
Interval 2.0 to 6.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 51Population: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Non-SAEs and SAEs
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Non-SAEs and SAEs
Non SAE
|
7 Participants
|
4 Participants
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Day 9
|
139.4 Grams per liter
Standard Deviation 18.82
|
140.0 Grams per liter
Standard Deviation 13.60
|
143.7 Grams per liter
Standard Deviation 10.15
|
137.7 Grams per liter
Standard Deviation 11.49
|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Day 14
|
140.7 Grams per liter
Standard Deviation 14.01
|
140.1 Grams per liter
Standard Deviation 12.91
|
142.1 Grams per liter
Standard Deviation 16.28
|
142.2 Grams per liter
Standard Deviation 15.27
|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Baseline (Day -2)
|
141.8 Grams per liter
Standard Deviation 12.90
|
140.5 Grams per liter
Standard Deviation 15.05
|
141.6 Grams per liter
Standard Deviation 15.47
|
141.7 Grams per liter
Standard Deviation 14.37
|
|
Part 2: Absolute Values for Hematology Parameter: Hemoglobin
Day 8
|
139.9 Grams per liter
Standard Deviation 14.26
|
140.3 Grams per liter
Standard Deviation 13.45
|
140.4 Grams per liter
Standard Deviation 14.81
|
143.4 Grams per liter
Standard Deviation 15.00
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Hematocrit
Baseline (Day -2)
|
0.4163 Proportion of red blood cells in blood
Standard Deviation 0.03226
|
0.4131 Proportion of red blood cells in blood
Standard Deviation 0.03985
|
0.4157 Proportion of red blood cells in blood
Standard Deviation 0.04031
|
0.4167 Proportion of red blood cells in blood
Standard Deviation 0.03829
|
|
Part 2: Absolute Values for Hematology Parameter: Hematocrit
Day 14
|
0.4118 Proportion of red blood cells in blood
Standard Deviation 0.03753
|
0.4107 Proportion of red blood cells in blood
Standard Deviation 0.03242
|
0.4175 Proportion of red blood cells in blood
Standard Deviation 0.04266
|
0.4189 Proportion of red blood cells in blood
Standard Deviation 0.03960
|
|
Part 2: Absolute Values for Hematology Parameter: Hematocrit
Day 8
|
0.4099 Proportion of red blood cells in blood
Standard Deviation 0.03700
|
0.4120 Proportion of red blood cells in blood
Standard Deviation 0.03334
|
0.4123 Proportion of red blood cells in blood
Standard Deviation 0.03874
|
0.4171 Proportion of red blood cells in blood
Standard Deviation 0.03831
|
|
Part 2: Absolute Values for Hematology Parameter: Hematocrit
Day 9
|
0.4134 Proportion of red blood cells in blood
Standard Deviation 0.04315
|
0.4086 Proportion of red blood cells in blood
Standard Deviation 0.03431
|
0.4247 Proportion of red blood cells in blood
Standard Deviation 0.02835
|
0.4029 Proportion of red blood cells in blood
Standard Deviation 0.03272
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Baseline (Day -2)
|
85.93 Femtoliter
Standard Deviation 5.041
|
85.96 Femtoliter
Standard Deviation 5.039
|
86.26 Femtoliter
Standard Deviation 4.971
|
85.92 Femtoliter
Standard Deviation 4.767
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 8
|
85.95 Femtoliter
Standard Deviation 3.851
|
85.57 Femtoliter
Standard Deviation 5.391
|
86.29 Femtoliter
Standard Deviation 5.417
|
84.91 Femtoliter
Standard Deviation 4.948
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 9
|
85.00 Femtoliter
Standard Deviation 7.113
|
86.42 Femtoliter
Standard Deviation 3.592
|
84.61 Femtoliter
Standard Deviation 2.623
|
87.08 Femtoliter
Standard Deviation 4.109
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 14
|
86.25 Femtoliter
Standard Deviation 3.841
|
86.17 Femtoliter
Standard Deviation 5.378
|
86.05 Femtoliter
Standard Deviation 5.265
|
85.53 Femtoliter
Standard Deviation 4.993
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Baseline (Day -2)
|
29.27 Picograms
Standard Deviation 2.308
|
29.23 Picograms
Standard Deviation 2.077
|
29.37 Picograms
Standard Deviation 2.062
|
29.21 Picograms
Standard Deviation 2.005
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 8
|
29.34 Picograms
Standard Deviation 1.603
|
29.13 Picograms
Standard Deviation 2.325
|
29.39 Picograms
Standard Deviation 2.273
|
29.17 Picograms
Standard Deviation 2.189
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 9
|
28.67 Picograms
Standard Deviation 3.417
|
29.56 Picograms
Standard Deviation 1.551
|
28.62 Picograms
Standard Deviation 1.362
|
29.79 Picograms
Standard Deviation 1.516
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 14
|
29.45 Picograms
Standard Deviation 1.487
|
29.40 Picograms
Standard Deviation 2.449
|
29.29 Picograms
Standard Deviation 2.227
|
29.02 Picograms
Standard Deviation 2.137
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils,Baseline (Day -2)
|
0.035 10^9 cells per liter
Standard Deviation 0.0194
|
0.036 10^9 cells per liter
Standard Deviation 0.0228
|
0.037 10^9 cells per liter
Standard Deviation 0.0218
|
0.031 10^9 cells per liter
Standard Deviation 0.0121
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils,Day 8
|
0.035 10^9 cells per liter
Standard Deviation 0.0228
|
0.032 10^9 cells per liter
Standard Deviation 0.0176
|
0.030 10^9 cells per liter
Standard Deviation 0.0149
|
0.039 10^9 cells per liter
Standard Deviation 0.0157
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils,Day 9
|
0.032 10^9 cells per liter
Standard Deviation 0.0155
|
0.036 10^9 cells per liter
Standard Deviation 0.0191
|
0.039 10^9 cells per liter
Standard Deviation 0.0145
|
0.025 10^9 cells per liter
Standard Deviation 0.0108
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils,Day 9
|
0.167 10^9 cells per liter
Standard Deviation 0.0859
|
0.120 10^9 cells per liter
Standard Deviation 0.0754
|
0.114 10^9 cells per liter
Standard Deviation 0.0688
|
0.081 10^9 cells per liter
Standard Deviation 0.0418
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils,Day 14
|
0.113 10^9 cells per liter
Standard Deviation 0.0765
|
0.131 10^9 cells per liter
Standard Deviation 0.0918
|
0.126 10^9 cells per liter
Standard Deviation 0.0717
|
0.141 10^9 cells per liter
Standard Deviation 0.0737
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes,Day 8
|
1.641 10^9 cells per liter
Standard Deviation 0.4661
|
1.605 10^9 cells per liter
Standard Deviation 0.4496
|
1.675 10^9 cells per liter
Standard Deviation 0.5013
|
1.688 10^9 cells per liter
Standard Deviation 0.4620
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes,Day 9
|
1.603 10^9 cells per liter
Standard Deviation 0.2137
|
1.907 10^9 cells per liter
Standard Deviation 0.6142
|
1.637 10^9 cells per liter
Standard Deviation 0.5265
|
1.540 10^9 cells per liter
Standard Deviation 0.5550
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes,Day 14
|
1.710 10^9 cells per liter
Standard Deviation 0.5906
|
1.606 10^9 cells per liter
Standard Deviation 0.5602
|
1.705 10^9 cells per liter
Standard Deviation 0.4747
|
1.755 10^9 cells per liter
Standard Deviation 0.5892
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes,Baseline (Day -2)
|
0.427 10^9 cells per liter
Standard Deviation 0.1533
|
0.442 10^9 cells per liter
Standard Deviation 0.1429
|
0.451 10^9 cells per liter
Standard Deviation 0.1588
|
0.429 10^9 cells per liter
Standard Deviation 0.1476
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes,Day 9
|
0.485 10^9 cells per liter
Standard Deviation 0.1499
|
0.468 10^9 cells per liter
Standard Deviation 0.1376
|
0.389 10^9 cells per liter
Standard Deviation 0.1312
|
0.350 10^9 cells per liter
Standard Deviation 0.1040
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes,Day 14
|
0.413 10^9 cells per liter
Standard Deviation 0.1474
|
0.399 10^9 cells per liter
Standard Deviation 0.1469
|
0.431 10^9 cells per liter
Standard Deviation 0.1514
|
0.448 10^9 cells per liter
Standard Deviation 0.1402
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Baseline (Day -2)
|
2.842 10^9 cells per liter
Standard Deviation 0.9011
|
2.902 10^9 cells per liter
Standard Deviation 0.8438
|
2.957 10^9 cells per liter
Standard Deviation 1.0517
|
2.829 10^9 cells per liter
Standard Deviation 0.8172
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils,Day 8
|
2.889 10^9 cells per liter
Standard Deviation 0.9751
|
2.671 10^9 cells per liter
Standard Deviation 0.8247
|
2.825 10^9 cells per liter
Standard Deviation 0.8364
|
2.952 10^9 cells per liter
Standard Deviation 0.9562
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets,Baseline (Day -2)
|
233.7 10^9 cells per liter
Standard Deviation 42.39
|
237.1 10^9 cells per liter
Standard Deviation 46.09
|
234.0 10^9 cells per liter
Standard Deviation 48.15
|
230.8 10^9 cells per liter
Standard Deviation 48.34
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 8
|
228.9 10^9 cells per liter
Standard Deviation 43.10
|
226.4 10^9 cells per liter
Standard Deviation 43.06
|
234.8 10^9 cells per liter
Standard Deviation 47.94
|
224.7 10^9 cells per liter
Standard Deviation 41.97
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 9
|
221.4 10^9 cells per liter
Standard Deviation 34.16
|
233.3 10^9 cells per liter
Standard Deviation 62.32
|
225.9 10^9 cells per liter
Standard Deviation 52.60
|
235.4 10^9 cells per liter
Standard Deviation 30.80
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Baseline (Day -2)
|
5.12 10^9 cells per liter
Standard Deviation 1.205
|
5.34 10^9 cells per liter
Standard Deviation 1.153
|
5.31 10^9 cells per liter
Standard Deviation 1.325
|
5.08 10^9 cells per liter
Standard Deviation 1.092
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes,Day 8
|
5.10 10^9 cells per liter
Standard Deviation 1.223
|
4.87 10^9 cells per liter
Standard Deviation 0.985
|
5.11 10^9 cells per liter
Standard Deviation 1.151
|
5.32 10^9 cells per liter
Standard Deviation 1.172
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes,Day 9
|
5.27 10^9 cells per liter
Standard Deviation 1.125
|
5.14 10^9 cells per liter
Standard Deviation 1.307
|
4.78 10^9 cells per liter
Standard Deviation 1.411
|
4.53 10^9 cells per liter
Standard Deviation 0.850
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes,Day 14
|
4.97 10^9 cells per liter
Standard Deviation 1.184
|
4.67 10^9 cells per liter
Standard Deviation 1.040
|
5.05 10^9 cells per liter
Standard Deviation 1.054
|
5.14 10^9 cells per liter
Standard Deviation 1.023
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 14
|
231.6 10^9 cells per liter
Standard Deviation 48.26
|
227.1 10^9 cells per liter
Standard Deviation 44.07
|
234.0 10^9 cells per liter
Standard Deviation 40.87
|
226.7 10^9 cells per liter
Standard Deviation 46.75
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils,Day 14
|
0.033 10^9 cells per liter
Standard Deviation 0.0178
|
0.031 10^9 cells per liter
Standard Deviation 0.0161
|
0.033 10^9 cells per liter
Standard Deviation 0.0177
|
0.040 10^9 cells per liter
Standard Deviation 0.0242
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils,Baseline (Day -2)
|
0.124 10^9 cells per liter
Standard Deviation 0.0775
|
0.127 10^9 cells per liter
Standard Deviation 0.0794
|
0.135 10^9 cells per liter
Standard Deviation 0.0966
|
0.123 10^9 cells per liter
Standard Deviation 0.0716
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils,Day 8
|
0.116 10^9 cells per liter
Standard Deviation 0.0637
|
0.136 10^9 cells per liter
Standard Deviation 0.0757
|
0.130 10^9 cells per liter
Standard Deviation 0.0797
|
0.135 10^9 cells per liter
Standard Deviation 0.0725
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes,Baseline (Day -2)
|
1.694 10^9 cells per liter
Standard Deviation 0.5355
|
1.830 10^9 cells per liter
Standard Deviation 0.5683
|
1.736 10^9 cells per liter
Standard Deviation 0.5498
|
1.677 10^9 cells per liter
Standard Deviation 0.4789
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes,Day 8
|
0.426 10^9 cells per liter
Standard Deviation 0.1090
|
0.436 10^9 cells per liter
Standard Deviation 0.1518
|
0.456 10^9 cells per liter
Standard Deviation 0.1521
|
0.501 10^9 cells per liter
Standard Deviation 0.1609
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils,Day 9
|
2.990 10^9 cells per liter
Standard Deviation 0.9534
|
2.618 10^9 cells per liter
Standard Deviation 0.8351
|
2.619 10^9 cells per liter
Standard Deviation 1.1073
|
2.530 10^9 cells per liter
Standard Deviation 0.5010
|
|
Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils,Day 14
|
2.712 10^9 cells per liter
Standard Deviation 0.8786
|
2.506 10^9 cells per liter
Standard Deviation 0.7270
|
2.758 10^9 cells per liter
Standard Deviation 0.8062
|
2.750 10^9 cells per liter
Standard Deviation 0.7833
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Baseline (Day -2)
|
4.859 10^12 cells per liter
Standard Deviation 0.4614
|
4.815 10^12 cells per liter
Standard Deviation 0.4808
|
4.829 10^12 cells per liter
Standard Deviation 0.4842
|
4.864 10^12 cells per liter
Standard Deviation 0.5017
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Day 14
|
4.782 10^12 cells per liter
Standard Deviation 0.4689
|
4.780 10^12 cells per liter
Standard Deviation 0.4388
|
4.866 10^12 cells per liter
Standard Deviation 0.5418
|
4.910 10^12 cells per liter
Standard Deviation 0.5078
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Day 8
|
4.775 10^12 cells per liter
Standard Deviation 0.4512
|
4.833 10^12 cells per liter
Standard Deviation 0.4585
|
4.794 10^12 cells per liter
Standard Deviation 0.5278
|
4.927 10^12 cells per liter
Standard Deviation 0.5074
|
|
Part 2: Absolute Values for Hematology Parameter: Erythrocytes
Day 9
|
4.890 10^12 cells per liter
Standard Deviation 0.6010
|
4.737 10^12 cells per liter
Standard Deviation 0.4416
|
5.023 10^12 cells per liter
Standard Deviation 0.3646
|
4.632 10^12 cells per liter
Standard Deviation 0.3654
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Day 8
|
-2.7 Grams per liter
Standard Deviation 5.58
|
0.1 Grams per liter
Standard Deviation 6.08
|
-0.9 Grams per liter
Standard Deviation 6.20
|
0.3 Grams per liter
Standard Deviation 4.45
|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Day 9
|
-0.6 Grams per liter
Standard Deviation 5.17
|
-1.3 Grams per liter
Standard Deviation 5.87
|
1.0 Grams per liter
Standard Deviation 6.54
|
0.0 Grams per liter
Standard Deviation 4.78
|
|
Part 2: Change From Baseline in Hematology Parameter: Hemoglobin
Day 14
|
-1.9 Grams per liter
Standard Deviation 6.15
|
-0.2 Grams per liter
Standard Deviation 5.43
|
0.8 Grams per liter
Standard Deviation 7.32
|
-0.9 Grams per liter
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze hematocrit . Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 14
|
-0.0052 Proportion of red blood cells in blood
Standard Deviation 0.01837
|
-0.0012 Proportion of red blood cells in blood
Standard Deviation 0.01728
|
0.0035 Proportion of red blood cells in blood
Standard Deviation 0.02158
|
-0.0026 Proportion of red blood cells in blood
Standard Deviation 0.01427
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 8
|
-0.0068 Proportion of red blood cells in blood
Standard Deviation 0.01715
|
0.0002 Proportion of red blood cells in blood
Standard Deviation 0.01915
|
-0.0018 Proportion of red blood cells in blood
Standard Deviation 0.01861
|
-0.0040 Proportion of red blood cells in blood
Standard Deviation 0.01256
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 9
|
-0.0009 Proportion of red blood cells in blood
Standard Deviation 0.01290
|
-0.0076 Proportion of red blood cells in blood
Standard Deviation 0.01928
|
0.0036 Proportion of red blood cells in blood
Standard Deviation 0.02174
|
-0.0007 Proportion of red blood cells in blood
Standard Deviation 0.01843
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 8
|
-0.57 Femtoliter
Standard Deviation 2.043
|
-0.26 Femtoliter
Standard Deviation 0.748
|
-0.45 Femtoliter
Standard Deviation 0.720
|
-0.55 Femtoliter
Standard Deviation 2.011
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 9
|
0.15 Femtoliter
Standard Deviation 0.438
|
0.10 Femtoliter
Standard Deviation 0.559
|
-0.01 Femtoliter
Standard Deviation 0.695
|
-0.20 Femtoliter
Standard Deviation 0.785
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Day 14
|
-0.33 Femtoliter
Standard Deviation 2.255
|
0.35 Femtoliter
Standard Deviation 2.379
|
-0.69 Femtoliter
Standard Deviation 2.122
|
-0.02 Femtoliter
Standard Deviation 2.074
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 9
|
-0.05 Picograms
Standard Deviation 0.635
|
0.27 Picograms
Standard Deviation 0.469
|
-0.06 Picograms
Standard Deviation 0.617
|
0.01 Picograms
Standard Deviation 0.486
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 8
|
-0.25 Picograms
Standard Deviation 1.052
|
-0.08 Picograms
Standard Deviation 0.379
|
-0.18 Picograms
Standard Deviation 0.417
|
0.15 Picograms
Standard Deviation 1.042
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Day 14
|
-0.15 Picograms
Standard Deviation 1.188
|
0.19 Picograms
Standard Deviation 1.186
|
-0.28 Picograms
Standard Deviation 1.073
|
-0.01 Picograms
Standard Deviation 1.113
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils,Day 8
|
-0.002 10^9 cells per liter
Standard Deviation 0.0141
|
-0.003 10^9 cells per liter
Standard Deviation 0.0111
|
-0.004 10^9 cells per liter
Standard Deviation 0.0088
|
0.005 10^9 cells per liter
Standard Deviation 0.0107
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils,Day 9
|
0.002 10^9 cells per liter
Standard Deviation 0.0123
|
-0.003 10^9 cells per liter
Standard Deviation 0.0101
|
-0.010 10^9 cells per liter
Standard Deviation 0.0240
|
0.002 10^9 cells per liter
Standard Deviation 0.0103
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils,Day 14
|
-0.005 10^9 cells per liter
Standard Deviation 0.0178
|
-0.004 10^9 cells per liter
Standard Deviation 0.0105
|
-0.001 10^9 cells per liter
Standard Deviation 0.0116
|
0.007 10^9 cells per liter
Standard Deviation 0.0245
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils,Day 8
|
0.002 10^9 cells per liter
Standard Deviation 0.0363
|
0.007 10^9 cells per liter
Standard Deviation 0.0405
|
-0.008 10^9 cells per liter
Standard Deviation 0.0525
|
-0.001 10^9 cells per liter
Standard Deviation 0.0367
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils,Day 9
|
0.008 10^9 cells per liter
Standard Deviation 0.0339
|
-0.004 10^9 cells per liter
Standard Deviation 0.0347
|
-0.011 10^9 cells per liter
Standard Deviation 0.0285
|
-0.002 10^9 cells per liter
Standard Deviation 0.0204
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils,Day 14
|
-0.004 10^9 cells per liter
Standard Deviation 0.0382
|
0.002 10^9 cells per liter
Standard Deviation 0.0641
|
-0.012 10^9 cells per liter
Standard Deviation 0.0528
|
0.006 10^9 cells per liter
Standard Deviation 0.0507
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes,Day 8
|
-0.129 10^9 cells per liter
Standard Deviation 0.3091
|
-0.161 10^9 cells per liter
Standard Deviation 0.3238
|
-0.071 10^9 cells per liter
Standard Deviation 0.3535
|
-0.039 10^9 cells per liter
Standard Deviation 0.2684
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes,Day 9
|
0.122 10^9 cells per liter
Standard Deviation 0.1852
|
-0.092 10^9 cells per liter
Standard Deviation 0.3865
|
-0.067 10^9 cells per liter
Standard Deviation 0.2649
|
0.015 10^9 cells per liter
Standard Deviation 0.2089
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 8
|
-7.4 10^9 cells per liter
Standard Deviation 23.57
|
-10.8 10^9 cells per liter
Standard Deviation 30.25
|
-2.2 10^9 cells per liter
Standard Deviation 28.56
|
-4.5 10^9 cells per liter
Standard Deviation 24.10
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes,Day 14
|
-0.066 10^9 cells per liter
Standard Deviation 0.2859
|
-0.160 10^9 cells per liter
Standard Deviation 0.2649
|
-0.041 10^9 cells per liter
Standard Deviation 0.3457
|
0.014 10^9 cells per liter
Standard Deviation 0.3589
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes,Day 8
|
0.001 10^9 cells per liter
Standard Deviation 0.1206
|
0.014 10^9 cells per liter
Standard Deviation 0.0900
|
-0.015 10^9 cells per liter
Standard Deviation 0.1119
|
0.034 10^9 cells per liter
Standard Deviation 0.1148
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes,Day 9
|
0.047 10^9 cells per liter
Standard Deviation 0.0638
|
-0.030 10^9 cells per liter
Standard Deviation 0.1627
|
0.010 10^9 cells per liter
Standard Deviation 0.0332
|
0.038 10^9 cells per liter
Standard Deviation 0.0382
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes,Day 14
|
-0.015 10^9 cells per liter
Standard Deviation 0.1347
|
-0.022 10^9 cells per liter
Standard Deviation 0.1413
|
-0.040 10^9 cells per liter
Standard Deviation 0.0967
|
-0.022 10^9 cells per liter
Standard Deviation 0.1388
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils,Day 8
|
0.018 10^9 cells per liter
Standard Deviation 0.8722
|
-0.272 10^9 cells per liter
Standard Deviation 0.6668
|
-0.319 10^9 cells per liter
Standard Deviation 0.7755
|
-0.022 10^9 cells per liter
Standard Deviation 0.7040
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils,Day 9
|
0.332 10^9 cells per liter
Standard Deviation 0.3485
|
-0.174 10^9 cells per liter
Standard Deviation 0.8246
|
0.306 10^9 cells per liter
Standard Deviation 0.4508
|
0.136 10^9 cells per liter
Standard Deviation 0.4495
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils,Day 14
|
-0.155 10^9 cells per liter
Standard Deviation 0.5886
|
-0.437 10^9 cells per liter
Standard Deviation 0.7038
|
-0.386 10^9 cells per liter
Standard Deviation 0.6994
|
-0.262 10^9 cells per liter
Standard Deviation 0.5618
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 9
|
-8.4 10^9 cells per liter
Standard Deviation 21.44
|
-3.5 10^9 cells per liter
Standard Deviation 22.10
|
0.7 10^9 cells per liter
Standard Deviation 25.99
|
7.9 10^9 cells per liter
Standard Deviation 28.29
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day 14
|
-3.2 10^9 cells per liter
Standard Deviation 34.31
|
-10.1 10^9 cells per liter
Standard Deviation 31.76
|
-2.5 10^9 cells per liter
Standard Deviation 31.02
|
-6.7 10^9 cells per liter
Standard Deviation 28.80
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes,Day 8
|
-0.11 10^9 cells per liter
Standard Deviation 1.122
|
-0.42 10^9 cells per liter
Standard Deviation 0.858
|
-0.41 10^9 cells per liter
Standard Deviation 0.943
|
-0.01 10^9 cells per liter
Standard Deviation 0.837
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes,Day 9
|
0.50 10^9 cells per liter
Standard Deviation 0.406
|
-0.32 10^9 cells per liter
Standard Deviation 1.138
|
0.20 10^9 cells per liter
Standard Deviation 0.505
|
0.21 10^9 cells per liter
Standard Deviation 0.626
|
|
Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes,Day 14
|
-0.24 10^9 cells per liter
Standard Deviation 0.669
|
-0.63 10^9 cells per liter
Standard Deviation 0.864
|
-0.47 10^9 cells per liter
Standard Deviation 0.856
|
-0.24 10^9 cells per liter
Standard Deviation 0.721
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 9
|
-0.023 10^12 cells per liter
Standard Deviation 0.1546
|
-0.090 10^12 cells per liter
Standard Deviation 0.2291
|
0.044 10^12 cells per liter
Standard Deviation 0.2637
|
0.004 10^12 cells per liter
Standard Deviation 0.2052
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 8
|
-0.049 10^12 cells per liter
Standard Deviation 0.2246
|
0.022 10^12 cells per liter
Standard Deviation 0.2160
|
0.008 10^12 cells per liter
Standard Deviation 0.2079
|
-0.015 10^12 cells per liter
Standard Deviation 0.1855
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 14
|
-0.043 10^12 cells per liter
Standard Deviation 0.2695
|
-0.031 10^12 cells per liter
Standard Deviation 0.2130
|
0.081 10^12 cells per liter
Standard Deviation 0.2488
|
-0.031 10^12 cells per liter
Standard Deviation 0.1956
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose,Baseline (Day -2)
|
4.813 Millimoles per liter
Standard Deviation 0.3180
|
4.739 Millimoles per liter
Standard Deviation 0.3538
|
4.810 Millimoles per liter
Standard Deviation 0.3038
|
4.753 Millimoles per liter
Standard Deviation 0.2744
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 8
|
4.777 Millimoles per liter
Standard Deviation 0.2914
|
4.749 Millimoles per liter
Standard Deviation 0.2843
|
4.798 Millimoles per liter
Standard Deviation 0.2707
|
4.670 Millimoles per liter
Standard Deviation 0.2420
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 9
|
4.763 Millimoles per liter
Standard Deviation 0.2295
|
4.668 Millimoles per liter
Standard Deviation 0.4071
|
4.811 Millimoles per liter
Standard Deviation 0.3717
|
4.791 Millimoles per liter
Standard Deviation 0.2795
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 14
|
4.794 Millimoles per liter
Standard Deviation 0.2526
|
4.777 Millimoles per liter
Standard Deviation 0.2745
|
4.713 Millimoles per liter
Standard Deviation 0.3106
|
4.749 Millimoles per liter
Standard Deviation 0.2474
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Baseline (Day -2)
|
4.323 Millimoles per liter
Standard Deviation 0.8707
|
4.330 Millimoles per liter
Standard Deviation 0.7859
|
4.243 Millimoles per liter
Standard Deviation 0.8603
|
4.350 Millimoles per liter
Standard Deviation 0.7624
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 8,
|
4.300 Millimoles per liter
Standard Deviation 0.8340
|
4.246 Millimoles per liter
Standard Deviation 0.8197
|
4.147 Millimoles per liter
Standard Deviation 0.7439
|
4.186 Millimoles per liter
Standard Deviation 0.7233
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 9
|
3.988 Millimoles per liter
Standard Deviation 0.5501
|
4.253 Millimoles per liter
Standard Deviation 0.8441
|
4.467 Millimoles per liter
Standard Deviation 0.8551
|
4.050 Millimoles per liter
Standard Deviation 0.7872
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 14
|
4.361 Millimoles per liter
Standard Deviation 0.8290
|
4.180 Millimoles per liter
Standard Deviation 0.8088
|
4.233 Millimoles per liter
Standard Deviation 0.7982
|
4.145 Millimoles per liter
Standard Deviation 0.7483
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Baseline (Day -2)
|
0.794 Millimoles per liter
Standard Deviation 0.0653
|
0.796 Millimoles per liter
Standard Deviation 0.0688
|
0.791 Millimoles per liter
Standard Deviation 0.0679
|
0.793 Millimoles per liter
Standard Deviation 0.0709
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 8
|
0.793 Millimoles per liter
Standard Deviation 0.0499
|
0.769 Millimoles per liter
Standard Deviation 0.0565
|
0.783 Millimoles per liter
Standard Deviation 0.0610
|
0.793 Millimoles per liter
Standard Deviation 0.0539
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 9
|
0.736 Millimoles per liter
Standard Deviation 0.0610
|
0.820 Millimoles per liter
Standard Deviation 0.0400
|
0.771 Millimoles per liter
Standard Deviation 0.0521
|
0.817 Millimoles per liter
Standard Deviation 0.0736
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 14
|
0.796 Millimoles per liter
Standard Deviation 0.0627
|
0.789 Millimoles per liter
Standard Deviation 0.0662
|
0.801 Millimoles per liter
Standard Deviation 0.0675
|
0.796 Millimoles per liter
Standard Deviation 0.0579
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Baseline (Day -2)
|
1.011 Millimoles per liter
Standard Deviation 0.4865
|
1.059 Millimoles per liter
Standard Deviation 0.4907
|
0.996 Millimoles per liter
Standard Deviation 0.4214
|
0.978 Millimoles per liter
Standard Deviation 0.4082
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 8
|
0.977 Millimoles per liter
Standard Deviation 0.4124
|
0.958 Millimoles per liter
Standard Deviation 0.4513
|
0.980 Millimoles per liter
Standard Deviation 0.3876
|
0.894 Millimoles per liter
Standard Deviation 0.3583
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 9
|
1.036 Millimoles per liter
Standard Deviation 0.4571
|
0.935 Millimoles per liter
Standard Deviation 0.2874
|
0.891 Millimoles per liter
Standard Deviation 0.3760
|
0.778 Millimoles per liter
Standard Deviation 0.4061
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 14
|
0.948 Millimoles per liter
Standard Deviation 0.3862
|
0.941 Millimoles per liter
Standard Deviation 0.3983
|
1.013 Millimoles per liter
Standard Deviation 0.4432
|
1.049 Millimoles per liter
Standard Deviation 0.3844
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Baseline (Day -2)
|
10.0 Millimoles per liter
Standard Deviation 1.46
|
10.2 Millimoles per liter
Standard Deviation 1.42
|
9.9 Millimoles per liter
Standard Deviation 1.61
|
10.5 Millimoles per liter
Standard Deviation 1.65
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 8
|
10.1 Millimoles per liter
Standard Deviation 1.41
|
10.3 Millimoles per liter
Standard Deviation 1.20
|
10.1 Millimoles per liter
Standard Deviation 1.44
|
10.1 Millimoles per liter
Standard Deviation 1.41
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 9
|
10.0 Millimoles per liter
Standard Deviation 1.56
|
11.1 Millimoles per liter
Standard Deviation 1.64
|
10.8 Millimoles per liter
Standard Deviation 1.30
|
10.8 Millimoles per liter
Standard Deviation 1.69
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 14
|
9.9 Millimoles per liter
Standard Deviation 1.36
|
9.9 Millimoles per liter
Standard Deviation 1.36
|
10.2 Millimoles per liter
Standard Deviation 1.42
|
9.8 Millimoles per liter
Standard Deviation 1.35
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Baseline (Day -2)
|
2.371 Millimoles per liter
Standard Deviation 0.0868
|
2.363 Millimoles per liter
Standard Deviation 0.0942
|
2.350 Millimoles per liter
Standard Deviation 0.0939
|
2.375 Millimoles per liter
Standard Deviation 0.0922
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 8
|
2.317 Millimoles per liter
Standard Deviation 0.0920
|
2.316 Millimoles per liter
Standard Deviation 0.0893
|
2.316 Millimoles per liter
Standard Deviation 0.0876
|
2.316 Millimoles per liter
Standard Deviation 0.0945
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 9
|
2.357 Millimoles per liter
Standard Deviation 0.0793
|
2.366 Millimoles per liter
Standard Deviation 0.0595
|
2.402 Millimoles per liter
Standard Deviation 0.0978
|
2.332 Millimoles per liter
Standard Deviation 0.0627
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 14
|
2.367 Millimoles per liter
Standard Deviation 0.0913
|
2.349 Millimoles per liter
Standard Deviation 0.0802
|
2.391 Millimoles per liter
Standard Deviation 0.0918
|
2.358 Millimoles per liter
Standard Deviation 0.1040
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Baseline (Day -2)
|
30.4 Millimoles per liter
Standard Deviation 2.08
|
30.2 Millimoles per liter
Standard Deviation 1.42
|
30.5 Millimoles per liter
Standard Deviation 1.58
|
30.2 Millimoles per liter
Standard Deviation 2.07
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 8
|
29.3 Millimoles per liter
Standard Deviation 2.32
|
29.6 Millimoles per liter
Standard Deviation 1.76
|
29.2 Millimoles per liter
Standard Deviation 1.63
|
29.3 Millimoles per liter
Standard Deviation 1.95
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 9
|
30.2 Millimoles per liter
Standard Deviation 1.55
|
29.2 Millimoles per liter
Standard Deviation 1.54
|
30.0 Millimoles per liter
Standard Deviation 2.18
|
28.9 Millimoles per liter
Standard Deviation 2.13
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 14
|
30.3 Millimoles per liter
Standard Deviation 1.84
|
30.3 Millimoles per liter
Standard Deviation 1.85
|
30.5 Millimoles per liter
Standard Deviation 1.82
|
30.8 Millimoles per liter
Standard Deviation 1.68
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Baseline (Day -2)
|
102.8 Millimoles per liter
Standard Deviation 1.57
|
103.4 Millimoles per liter
Standard Deviation 1.87
|
103.3 Millimoles per liter
Standard Deviation 2.05
|
103.2 Millimoles per liter
Standard Deviation 1.98
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 8
|
103.5 Millimoles per liter
Standard Deviation 1.91
|
102.6 Millimoles per liter
Standard Deviation 1.61
|
103.0 Millimoles per liter
Standard Deviation 1.64
|
102.5 Millimoles per liter
Standard Deviation 1.80
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 9
|
102.4 Millimoles per liter
Standard Deviation 1.51
|
103.9 Millimoles per liter
Standard Deviation 1.76
|
102.8 Millimoles per liter
Standard Deviation 1.72
|
103.0 Millimoles per liter
Standard Deviation 1.63
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 14
|
103.9 Millimoles per liter
Standard Deviation 1.77
|
103.3 Millimoles per liter
Standard Deviation 1.34
|
103.6 Millimoles per liter
Standard Deviation 1.70
|
103.5 Millimoles per liter
Standard Deviation 1.74
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Baseline (Day -2)
|
1.190 Millimoles per liter
Standard Deviation 0.1394
|
1.199 Millimoles per liter
Standard Deviation 0.1552
|
1.182 Millimoles per liter
Standard Deviation 0.1550
|
1.172 Millimoles per liter
Standard Deviation 0.1686
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 8
|
1.194 Millimoles per liter
Standard Deviation 0.1272
|
1.195 Millimoles per liter
Standard Deviation 0.1410
|
1.186 Millimoles per liter
Standard Deviation 0.1408
|
1.168 Millimoles per liter
Standard Deviation 0.1644
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 9
|
1.166 Millimoles per liter
Standard Deviation 0.1436
|
1.292 Millimoles per liter
Standard Deviation 0.1254
|
1.212 Millimoles per liter
Standard Deviation 0.1213
|
1.193 Millimoles per liter
Standard Deviation 0.1076
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 14
|
1.233 Millimoles per liter
Standard Deviation 0.1450
|
1.164 Millimoles per liter
Standard Deviation 0.1264
|
1.222 Millimoles per liter
Standard Deviation 0.1415
|
1.219 Millimoles per liter
Standard Deviation 0.1625
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Baseline (Day -2)
|
4.30 Millimoles per liter
Standard Deviation 0.337
|
4.34 Millimoles per liter
Standard Deviation 0.327
|
4.35 Millimoles per liter
Standard Deviation 0.315
|
4.32 Millimoles per liter
Standard Deviation 0.331
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 8
|
4.29 Millimoles per liter
Standard Deviation 0.291
|
4.26 Millimoles per liter
Standard Deviation 0.324
|
4.20 Millimoles per liter
Standard Deviation 0.275
|
4.07 Millimoles per liter
Standard Deviation 0.296
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 9
|
4.26 Millimoles per liter
Standard Deviation 0.222
|
4.17 Millimoles per liter
Standard Deviation 0.310
|
4.42 Millimoles per liter
Standard Deviation 0.484
|
4.18 Millimoles per liter
Standard Deviation 0.416
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 14
|
4.39 Millimoles per liter
Standard Deviation 0.389
|
4.41 Millimoles per liter
Standard Deviation 0.232
|
4.43 Millimoles per liter
Standard Deviation 0.301
|
4.44 Millimoles per liter
Standard Deviation 0.337
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Baseline (Day -2)
|
138.8 Millimoles per liter
Standard Deviation 1.91
|
139.4 Millimoles per liter
Standard Deviation 1.80
|
139.2 Millimoles per liter
Standard Deviation 2.18
|
139.4 Millimoles per liter
Standard Deviation 1.51
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 8
|
138.6 Millimoles per liter
Standard Deviation 1.89
|
138.2 Millimoles per liter
Standard Deviation 1.55
|
138.1 Millimoles per liter
Standard Deviation 1.25
|
137.8 Millimoles per liter
Standard Deviation 1.70
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 9
|
138.4 Millimoles per liter
Standard Deviation 0.70
|
139.9 Millimoles per liter
Standard Deviation 2.21
|
139.2 Millimoles per liter
Standard Deviation 1.39
|
138.6 Millimoles per liter
Standard Deviation 1.43
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 14
|
139.6 Millimoles per liter
Standard Deviation 1.65
|
139.0 Millimoles per liter
Standard Deviation 1.61
|
139.9 Millimoles per liter
Standard Deviation 1.20
|
139.6 Millimoles per liter
Standard Deviation 2.01
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Baseline(Day-2)
|
4.325 Millimoles per liter
Standard Deviation 1.0398
|
4.419 Millimoles per liter
Standard Deviation 0.9822
|
4.573 Millimoles per liter
Standard Deviation 1.3349
|
4.414 Millimoles per liter
Standard Deviation 1.2366
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 8
|
5.242 Millimoles per liter
Standard Deviation 0.9369
|
5.156 Millimoles per liter
Standard Deviation 1.0329
|
4.805 Millimoles per liter
Standard Deviation 0.8952
|
4.675 Millimoles per liter
Standard Deviation 0.9487
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 9
|
4.472 Millimoles per liter
Standard Deviation 0.5020
|
5.453 Millimoles per liter
Standard Deviation 0.9684
|
5.251 Millimoles per liter
Standard Deviation 0.6649
|
4.243 Millimoles per liter
Standard Deviation 0.8860
|
|
Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 14
|
4.637 Millimoles per liter
Standard Deviation 0.7997
|
4.440 Millimoles per liter
Standard Deviation 0.9129
|
4.428 Millimoles per liter
Standard Deviation 0.9272
|
4.451 Millimoles per liter
Standard Deviation 0.9627
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactatedehydrogenase, Baseline(Day-2)
|
119.9 International units per liter
Standard Deviation 21.33
|
122.8 International units per liter
Standard Deviation 21.04
|
119.6 International units per liter
Standard Deviation 18.16
|
121.2 International units per liter
Standard Deviation 24.03
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 8
|
107.5 International units per liter
Standard Deviation 18.24
|
111.8 International units per liter
Standard Deviation 19.37
|
108.0 International units per liter
Standard Deviation 17.13
|
113.5 International units per liter
Standard Deviation 16.87
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 9
|
124.0 International units per liter
Standard Deviation 20.88
|
107.4 International units per liter
Standard Deviation 20.66
|
118.2 International units per liter
Standard Deviation 16.69
|
108.1 International units per liter
Standard Deviation 17.01
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 14
|
113.4 International units per liter
Standard Deviation 17.68
|
113.5 International units per liter
Standard Deviation 17.09
|
116.6 International units per liter
Standard Deviation 18.19
|
118.8 International units per liter
Standard Deviation 20.87
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Baseline (Day -2)
|
18.3 International units per liter
Standard Deviation 10.92
|
16.8 International units per liter
Standard Deviation 10.26
|
17.5 International units per liter
Standard Deviation 10.40
|
16.3 International units per liter
Standard Deviation 9.35
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 8
|
14.0 International units per liter
Standard Deviation 7.46
|
17.2 International units per liter
Standard Deviation 9.80
|
15.7 International units per liter
Standard Deviation 10.63
|
19.5 International units per liter
Standard Deviation 11.46
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 9
|
26.6 International units per liter
Standard Deviation 16.04
|
12.5 International units per liter
Standard Deviation 9.50
|
14.2 International units per liter
Standard Deviation 4.29
|
16.4 International units per liter
Standard Deviation 8.69
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 14
|
13.8 International units per liter
Standard Deviation 6.38
|
18.7 International units per liter
Standard Deviation 12.07
|
16.6 International units per liter
Standard Deviation 11.05
|
19.0 International units per liter
Standard Deviation 11.34
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Baseline (Day -2)
|
58.7 International units per liter
Standard Deviation 13.67
|
58.3 International units per liter
Standard Deviation 13.52
|
58.0 International units per liter
Standard Deviation 13.82
|
58.9 International units per liter
Standard Deviation 14.23
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 8
|
56.8 International units per liter
Standard Deviation 11.95
|
55.6 International units per liter
Standard Deviation 12.06
|
57.1 International units per liter
Standard Deviation 12.81
|
59.6 International units per liter
Standard Deviation 13.52
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 9
|
56.1 International units per liter
Standard Deviation 15.32
|
63.5 International units per liter
Standard Deviation 15.28
|
58.9 International units per liter
Standard Deviation 12.64
|
53.0 International units per liter
Standard Deviation 8.03
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 14
|
56.7 International units per liter
Standard Deviation 13.21
|
55.1 International units per liter
Standard Deviation 10.80
|
58.8 International units per liter
Standard Deviation 13.98
|
59.4 International units per liter
Standard Deviation 14.15
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Baseline (Day -2)
|
15.8 International units per liter
Standard Deviation 4.73
|
15.5 International units per liter
Standard Deviation 4.56
|
15.5 International units per liter
Standard Deviation 3.78
|
15.3 International units per liter
Standard Deviation 3.88
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 8
|
14.0 International units per liter
Standard Deviation 3.18
|
16.0 International units per liter
Standard Deviation 9.92
|
13.7 International units per liter
Standard Deviation 3.14
|
15.6 International units per liter
Standard Deviation 4.01
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 9
|
17.3 International units per liter
Standard Deviation 5.14
|
13.6 International units per liter
Standard Deviation 3.26
|
15.6 International units per liter
Standard Deviation 5.05
|
15.1 International units per liter
Standard Deviation 3.75
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 14
|
14.1 International units per liter
Standard Deviation 3.10
|
15.3 International units per liter
Standard Deviation 3.81
|
14.5 International units per liter
Standard Deviation 3.96
|
15.8 International units per liter
Standard Deviation 5.22
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Baseline (Day -2)
|
16.7 International units per liter
Standard Deviation 11.06
|
17.2 International units per liter
Standard Deviation 11.41
|
16.6 International units per liter
Standard Deviation 8.75
|
16.7 International units per liter
Standard Deviation 10.53
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 8
|
15.0 International units per liter
Standard Deviation 11.16
|
17.9 International units per liter
Standard Deviation 11.53
|
15.2 International units per liter
Standard Deviation 7.30
|
18.7 International units per liter
Standard Deviation 10.22
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 9
|
20.3 International units per liter
Standard Deviation 7.63
|
12.5 International units per liter
Standard Deviation 6.56
|
19.1 International units per liter
Standard Deviation 11.61
|
10.8 International units per liter
Standard Deviation 2.44
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 14
|
14.7 International units per liter
Standard Deviation 10.48
|
17.5 International units per liter
Standard Deviation 12.44
|
15.1 International units per liter
Standard Deviation 7.28
|
17.7 International units per liter
Standard Deviation 9.01
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Baseline (Day -2)
|
103.0 International units per liter
Standard Deviation 61.10
|
120.8 International units per liter
Standard Deviation 95.60
|
112.6 International units per liter
Standard Deviation 91.50
|
117.8 International units per liter
Standard Deviation 105.69
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 8
|
72.8 International units per liter
Standard Deviation 42.00
|
163.9 International units per liter
Standard Deviation 428.51
|
82.5 International units per liter
Standard Deviation 48.77
|
90.3 International units per liter
Standard Deviation 51.09
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 9
|
173.4 International units per liter
Standard Deviation 136.99
|
75.5 International units per liter
Standard Deviation 45.25
|
171.1 International units per liter
Standard Deviation 184.31
|
81.1 International units per liter
Standard Deviation 40.14
|
|
Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 14
|
102.1 International units per liter
Standard Deviation 113.21
|
104.9 International units per liter
Standard Deviation 63.56
|
91.7 International units per liter
Standard Deviation 55.00
|
110.1 International units per liter
Standard Deviation 76.61
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Baseline (Day -2)
|
80.51 Micromoles per liter
Standard Deviation 13.855
|
79.38 Micromoles per liter
Standard Deviation 14.340
|
81.86 Micromoles per liter
Standard Deviation 14.819
|
79.83 Micromoles per liter
Standard Deviation 14.976
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 8
|
78.45 Micromoles per liter
Standard Deviation 16.058
|
88.55 Micromoles per liter
Standard Deviation 16.380
|
78.38 Micromoles per liter
Standard Deviation 15.118
|
82.01 Micromoles per liter
Standard Deviation 16.558
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 9
|
86.89 Micromoles per liter
Standard Deviation 13.446
|
77.07 Micromoles per liter
Standard Deviation 17.015
|
89.38 Micromoles per liter
Standard Deviation 14.323
|
80.63 Micromoles per liter
Standard Deviation 15.048
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 14
|
79.56 Micromoles per liter
Standard Deviation 16.792
|
84.19 Micromoles per liter
Standard Deviation 13.996
|
79.16 Micromoles per liter
Standard Deviation 15.043
|
81.47 Micromoles per liter
Standard Deviation 14.487
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Baseline (Day -2)
|
297.5 Micromoles per liter
Standard Deviation 60.11
|
294.6 Micromoles per liter
Standard Deviation 57.22
|
293.6 Micromoles per liter
Standard Deviation 62.59
|
295.3 Micromoles per liter
Standard Deviation 59.89
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 8
|
288.3 Micromoles per liter
Standard Deviation 53.21
|
302.1 Micromoles per liter
Standard Deviation 51.50
|
286.7 Micromoles per liter
Standard Deviation 58.76
|
277.6 Micromoles per liter
Standard Deviation 58.06
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 9
|
290.2 Micromoles per liter
Standard Deviation 64.04
|
295.3 Micromoles per liter
Standard Deviation 55.91
|
307.2 Micromoles per liter
Standard Deviation 46.23
|
261.1 Micromoles per liter
Standard Deviation 50.55
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 14
|
291.4 Micromoles per liter
Standard Deviation 49.07
|
293.1 Micromoles per liter
Standard Deviation 54.91
|
290.1 Micromoles per liter
Standard Deviation 56.69
|
285.4 Micromoles per liter
Standard Deviation 56.39
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Baseline (Day -2)
|
12.18 Micromoles per liter
Standard Deviation 6.249
|
11.79 Micromoles per liter
Standard Deviation 5.406
|
11.13 Micromoles per liter
Standard Deviation 4.812
|
11.79 Micromoles per liter
Standard Deviation 4.654
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 8
|
9.91 Micromoles per liter
Standard Deviation 3.647
|
10.36 Micromoles per liter
Standard Deviation 4.712
|
10.68 Micromoles per liter
Standard Deviation 4.792
|
11.63 Micromoles per liter
Standard Deviation 4.090
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 9
|
12.50 Micromoles per liter
Standard Deviation 6.712
|
13.71 Micromoles per liter
Standard Deviation 2.889
|
13.16 Micromoles per liter
Standard Deviation 6.586
|
12.00 Micromoles per liter
Standard Deviation 4.901
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 14
|
11.42 Micromoles per liter
Standard Deviation 4.666
|
12.89 Micromoles per liter
Standard Deviation 7.360
|
12.40 Micromoles per liter
Standard Deviation 5.214
|
11.53 Micromoles per liter
Standard Deviation 4.675
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Baseline (Day -2)
|
2.22 Micromoles per liter
Standard Deviation 0.988
|
2.12 Micromoles per liter
Standard Deviation 0.916
|
2.05 Micromoles per liter
Standard Deviation 0.834
|
2.07 Micromoles per liter
Standard Deviation 0.686
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 8
|
1.86 Micromoles per liter
Standard Deviation 0.689
|
1.90 Micromoles per liter
Standard Deviation 0.796
|
1.97 Micromoles per liter
Standard Deviation 0.811
|
2.22 Micromoles per liter
Standard Deviation 0.934
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 9
|
2.23 Micromoles per liter
Standard Deviation 1.033
|
2.39 Micromoles per liter
Standard Deviation 0.646
|
2.30 Micromoles per liter
Standard Deviation 1.127
|
2.23 Micromoles per liter
Standard Deviation 0.772
|
|
Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 14
|
2.06 Micromoles per liter
Standard Deviation 0.781
|
2.21 Micromoles per liter
Standard Deviation 1.113
|
2.22 Micromoles per liter
Standard Deviation 0.887
|
2.10 Micromoles per liter
Standard Deviation 0.844
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Total protein, Day 9
|
72.0 Grams per liter
Standard Deviation 3.09
|
67.9 Grams per liter
Standard Deviation 3.83
|
70.9 Grams per liter
Standard Deviation 4.14
|
69.1 Grams per liter
Standard Deviation 4.15
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Total protein, Day 14
|
68.2 Grams per liter
Standard Deviation 4.26
|
69.4 Grams per liter
Standard Deviation 3.80
|
70.3 Grams per liter
Standard Deviation 5.01
|
68.8 Grams per liter
Standard Deviation 5.09
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Albumin, Baseline (Day -2)
|
43.8 Grams per liter
Standard Deviation 2.89
|
44.0 Grams per liter
Standard Deviation 3.12
|
43.6 Grams per liter
Standard Deviation 3.18
|
44.5 Grams per liter
Standard Deviation 3.33
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Albumin, Day 8
|
41.7 Grams per liter
Standard Deviation 2.86
|
42.0 Grams per liter
Standard Deviation 3.39
|
42.2 Grams per liter
Standard Deviation 2.55
|
42.8 Grams per liter
Standard Deviation 2.57
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Albumin, Day 9
|
42.7 Grams per liter
Standard Deviation 2.83
|
43.5 Grams per liter
Standard Deviation 1.63
|
44.0 Grams per liter
Standard Deviation 3.28
|
43.5 Grams per liter
Standard Deviation 2.59
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Albumin, Day 14
|
43.2 Grams per liter
Standard Deviation 2.96
|
42.8 Grams per liter
Standard Deviation 2.68
|
43.9 Grams per liter
Standard Deviation 3.20
|
42.8 Grams per liter
Standard Deviation 2.59
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Globulin, Baseline (Day -2)
|
26.6 Grams per liter
Standard Deviation 4.43
|
26.0 Grams per liter
Standard Deviation 3.77
|
25.9 Grams per liter
Standard Deviation 3.99
|
26.3 Grams per liter
Standard Deviation 3.58
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Globulin, Day 8
|
25.1 Grams per liter
Standard Deviation 4.04
|
26.4 Grams per liter
Standard Deviation 3.89
|
25.5 Grams per liter
Standard Deviation 4.06
|
26.4 Grams per liter
Standard Deviation 3.51
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Globulin, Day 9
|
29.3 Grams per liter
Standard Deviation 1.89
|
24.5 Grams per liter
Standard Deviation 3.01
|
26.9 Grams per liter
Standard Deviation 3.89
|
25.6 Grams per liter
Standard Deviation 3.86
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Globulin, Day 14
|
25.0 Grams per liter
Standard Deviation 3.33
|
26.6 Grams per liter
Standard Deviation 3.88
|
26.4 Grams per liter
Standard Deviation 4.21
|
26.1 Grams per liter
Standard Deviation 3.84
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Total protein, Baseline (Day -2)
|
70.4 Grams per liter
Standard Deviation 5.22
|
70.0 Grams per liter
Standard Deviation 4.69
|
69.5 Grams per liter
Standard Deviation 4.55
|
70.7 Grams per liter
Standard Deviation 5.02
|
|
Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein
Total protein, Day 8
|
66.8 Grams per liter
Standard Deviation 4.09
|
68.4 Grams per liter
Standard Deviation 4.70
|
67.8 Grams per liter
Standard Deviation 4.31
|
69.2 Grams per liter
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Day 14
|
23.6 Units per liter
Standard Deviation 9.21
|
26.7 Units per liter
Standard Deviation 10.84
|
24.8 Units per liter
Standard Deviation 9.45
|
26.6 Units per liter
Standard Deviation 11.79
|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Baseline (Day -2)
|
55.7 Units per liter
Standard Deviation 21.74
|
55.9 Units per liter
Standard Deviation 22.19
|
58.2 Units per liter
Standard Deviation 24.65
|
56.2 Units per liter
Standard Deviation 25.45
|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Day 8
|
52.4 Units per liter
Standard Deviation 21.70
|
59.1 Units per liter
Standard Deviation 26.80
|
53.4 Units per liter
Standard Deviation 19.71
|
57.7 Units per liter
Standard Deviation 22.34
|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Day 9
|
66.3 Units per liter
Standard Deviation 19.41
|
49.2 Units per liter
Standard Deviation 16.70
|
61.0 Units per liter
Standard Deviation 26.37
|
44.6 Units per liter
Standard Deviation 17.40
|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Amylase, Day 14
|
50.9 Units per liter
Standard Deviation 20.92
|
58.5 Units per liter
Standard Deviation 24.58
|
52.9 Units per liter
Standard Deviation 20.11
|
58.0 Units per liter
Standard Deviation 21.02
|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Baseline (Day -2),
|
25.3 Units per liter
Standard Deviation 10.98
|
26.5 Units per liter
Standard Deviation 11.59
|
27.0 Units per liter
Standard Deviation 11.06
|
27.5 Units per liter
Standard Deviation 13.93
|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Day 8
|
29.3 Units per liter
Standard Deviation 27.50
|
26.5 Units per liter
Standard Deviation 12.22
|
25.2 Units per liter
Standard Deviation 12.39
|
26.6 Units per liter
Standard Deviation 12.87
|
|
Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase
Lipase, Day 9
|
28.4 Units per liter
Standard Deviation 12.99
|
23.7 Units per liter
Standard Deviation 10.47
|
28.1 Units per liter
Standard Deviation 12.26
|
22.7 Units per liter
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen.Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 8
|
-1.0 Millimoles per liter
Standard Deviation 1.95
|
-0.6 Millimoles per liter
Standard Deviation 1.62
|
-1.2 Millimoles per liter
Standard Deviation 1.63
|
-1.2 Millimoles per liter
Standard Deviation 2.12
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 9
|
-0.5 Millimoles per liter
Standard Deviation 1.90
|
-1.1 Millimoles per liter
Standard Deviation 1.45
|
-0.8 Millimoles per liter
Standard Deviation 1.86
|
-0.1 Millimoles per liter
Standard Deviation 1.10
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 8
|
0.7 Millimoles per liter
Standard Deviation 1.92
|
-0.6 Millimoles per liter
Standard Deviation 1.62
|
-0.2 Millimoles per liter
Standard Deviation 1.83
|
-0.4 Millimoles per liter
Standard Deviation 2.03
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 9
|
-0.6 Millimoles per liter
Standard Deviation 1.71
|
-0.2 Millimoles per liter
Standard Deviation 1.40
|
-1.0 Millimoles per liter
Standard Deviation 1.58
|
-1.1 Millimoles per liter
Standard Deviation 2.28
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Chloride, Day 14
|
1.0 Millimoles per liter
Standard Deviation 1.81
|
0.2 Millimoles per liter
Standard Deviation 1.85
|
0.5 Millimoles per liter
Standard Deviation 1.79
|
0.7 Millimoles per liter
Standard Deviation 2.22
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 8
|
-0.009 Millimoles per liter
Standard Deviation 0.1060
|
0.031 Millimoles per liter
Standard Deviation 0.0971
|
0.018 Millimoles per liter
Standard Deviation 0.0966
|
0.004 Millimoles per liter
Standard Deviation 0.1388
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 9
|
0.016 Millimoles per liter
Standard Deviation 0.0819
|
-0.001 Millimoles per liter
Standard Deviation 0.0641
|
-0.016 Millimoles per liter
Standard Deviation 0.0985
|
-0.005 Millimoles per liter
Standard Deviation 0.0593
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Phosphate, Day 14
|
0.027 Millimoles per liter
Standard Deviation 0.1225
|
0.000 Millimoles per liter
Standard Deviation 0.0961
|
0.054 Millimoles per liter
Standard Deviation 0.1156
|
0.047 Millimoles per liter
Standard Deviation 0.1375
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 8
|
-0.02 Millimoles per liter
Standard Deviation 0.458
|
-0.08 Millimoles per liter
Standard Deviation 0.302
|
-0.12 Millimoles per liter
Standard Deviation 0.401
|
-0.24 Millimoles per liter
Standard Deviation 0.455
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 9
|
-0.05 Millimoles per liter
Standard Deviation 0.299
|
-0.18 Millimoles per liter
Standard Deviation 0.343
|
-0.03 Millimoles per liter
Standard Deviation 0.346
|
-0.16 Millimoles per liter
Standard Deviation 0.295
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Potassium, Day 14
|
0.07 Millimoles per liter
Standard Deviation 0.448
|
0.07 Millimoles per liter
Standard Deviation 0.373
|
0.12 Millimoles per liter
Standard Deviation 0.343
|
0.14 Millimoles per liter
Standard Deviation 0.393
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 8
|
-0.4 Millimoles per liter
Standard Deviation 2.23
|
-0.9 Millimoles per liter
Standard Deviation 1.96
|
-0.9 Millimoles per liter
Standard Deviation 2.25
|
-1.7 Millimoles per liter
Standard Deviation 1.68
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 9
|
-0.4 Millimoles per liter
Standard Deviation 0.97
|
-0.4 Millimoles per liter
Standard Deviation 1.12
|
-0.4 Millimoles per liter
Standard Deviation 2.07
|
-0.4 Millimoles per liter
Standard Deviation 2.01
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Sodium, Day 14
|
0.5 Millimoles per liter
Standard Deviation 2.24
|
-0.1 Millimoles per liter
Standard Deviation 1.87
|
0.8 Millimoles per liter
Standard Deviation 2.13
|
0.1 Millimoles per liter
Standard Deviation 2.12
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 8
|
-0.041 Millimoles per liter
Standard Deviation 0.2820
|
0.029 Millimoles per liter
Standard Deviation 0.3396
|
-0.023 Millimoles per liter
Standard Deviation 0.3001
|
-0.024 Millimoles per liter
Standard Deviation 0.2263
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 9
|
0.023 Millimoles per liter
Standard Deviation 0.3045
|
-0.119 Millimoles per liter
Standard Deviation 0.3171
|
0.040 Millimoles per liter
Standard Deviation 0.1949
|
-0.139 Millimoles per liter
Standard Deviation 0.2262
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Glucose, Day 14
|
-0.033 Millimoles per liter
Standard Deviation 0.3197
|
0.057 Millimoles per liter
Standard Deviation 0.2787
|
-0.109 Millimoles per liter
Standard Deviation 0.3220
|
0.046 Millimoles per liter
Standard Deviation 0.2481
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 8
|
-0.148 Millimoles per liter
Standard Deviation 0.4156
|
-0.116 Millimoles per liter
Standard Deviation 0.4323
|
-0.054 Millimoles per liter
Standard Deviation 0.3518
|
-0.201 Millimoles per liter
Standard Deviation 0.3767
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 9
|
-0.036 Millimoles per liter
Standard Deviation 0.3198
|
0.005 Millimoles per liter
Standard Deviation 0.4131
|
0.081 Millimoles per liter
Standard Deviation 0.4041
|
-0.186 Millimoles per liter
Standard Deviation 0.3427
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Cholesterol, Day 14
|
-0.102 Millimoles per liter
Standard Deviation 0.5090
|
-0.181 Millimoles per liter
Standard Deviation 0.4539
|
0.032 Millimoles per liter
Standard Deviation 0.4605
|
-0.273 Millimoles per liter
Standard Deviation 0.4303
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 8
|
-0.017 Millimoles per liter
Standard Deviation 0.0443
|
-0.018 Millimoles per liter
Standard Deviation 0.0379
|
-0.011 Millimoles per liter
Standard Deviation 0.0364
|
0.005 Millimoles per liter
Standard Deviation 0.0394
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 9
|
-0.020 Millimoles per liter
Standard Deviation 0.0389
|
-0.001 Millimoles per liter
Standard Deviation 0.0370
|
-0.013 Millimoles per liter
Standard Deviation 0.0200
|
0.009 Millimoles per liter
Standard Deviation 0.0328
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Magnesium, Day 14
|
-0.013 Millimoles per liter
Standard Deviation 0.0431
|
0.002 Millimoles per liter
Standard Deviation 0.0334
|
0.008 Millimoles per liter
Standard Deviation 0.0379
|
0.003 Millimoles per liter
Standard Deviation 0.0353
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 8
|
-0.019 Millimoles per liter
Standard Deviation 0.3330
|
-0.111 Millimoles per liter
Standard Deviation 0.3637
|
-0.002 Millimoles per liter
Standard Deviation 0.2699
|
-0.100 Millimoles per liter
Standard Deviation 0.3027
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 9
|
-0.050 Millimoles per liter
Standard Deviation 0.3006
|
-0.097 Millimoles per liter
Standard Deviation 0.2744
|
-0.153 Millimoles per liter
Standard Deviation 0.1572
|
-0.151 Millimoles per liter
Standard Deviation 0.1979
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Triglycerides, Day 14
|
-0.052 Millimoles per liter
Standard Deviation 0.2523
|
-0.127 Millimoles per liter
Standard Deviation 0.3297
|
0.031 Millimoles per liter
Standard Deviation 0.3383
|
0.035 Millimoles per liter
Standard Deviation 0.2705
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 8
|
-0.2 Millimoles per liter
Standard Deviation 2.02
|
0.1 Millimoles per liter
Standard Deviation 1.35
|
0.0 Millimoles per liter
Standard Deviation 1.92
|
-0.4 Millimoles per liter
Standard Deviation 2.10
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 9
|
0.8 Millimoles per liter
Standard Deviation 1.55
|
1.0 Millimoles per liter
Standard Deviation 1.10
|
1.2 Millimoles per liter
Standard Deviation 0.83
|
0.4 Millimoles per liter
Standard Deviation 1.65
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Anion gap, Day 14
|
-0.4 Millimoles per liter
Standard Deviation 1.63
|
-0.3 Millimoles per liter
Standard Deviation 1.51
|
0.1 Millimoles per liter
Standard Deviation 1.77
|
-0.8 Millimoles per liter
Standard Deviation 1.75
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 8
|
-0.059 Millimoles per liter
Standard Deviation 0.0737
|
-0.037 Millimoles per liter
Standard Deviation 0.0795
|
-0.034 Millimoles per liter
Standard Deviation 0.0744
|
-0.063 Millimoles per liter
Standard Deviation 0.0617
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 9
|
0.001 Millimoles per liter
Standard Deviation 0.0798
|
-0.025 Millimoles per liter
Standard Deviation 0.1053
|
0.050 Millimoles per liter
Standard Deviation 0.0825
|
-0.032 Millimoles per liter
Standard Deviation 0.0780
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Calcium, Day 14
|
-0.010 Millimoles per liter
Standard Deviation 0.0754
|
-0.003 Millimoles per liter
Standard Deviation 0.0555
|
0.042 Millimoles per liter
Standard Deviation 0.0671
|
-0.020 Millimoles per liter
Standard Deviation 0.0584
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Carbon dioxide, Day 14
|
-0.2 Millimoles per liter
Standard Deviation 1.46
|
0.2 Millimoles per liter
Standard Deviation 1.92
|
0.1 Millimoles per liter
Standard Deviation 2.05
|
0.3 Millimoles per liter
Standard Deviation 1.79
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 8
|
0.751 Millimoles per liter
Standard Deviation 1.0248
|
0.890 Millimoles per liter
Standard Deviation 0.7840
|
0.385 Millimoles per liter
Standard Deviation 0.9919
|
0.225 Millimoles per liter
Standard Deviation 1.1465
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 9
|
0.557 Millimoles per liter
Standard Deviation 0.2739
|
0.631 Millimoles per liter
Standard Deviation 0.5449
|
0.154 Millimoles per liter
Standard Deviation 0.7635
|
-0.060 Millimoles per liter
Standard Deviation 0.7601
|
|
Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen
Blood Urea Nitrogen, Day 14
|
0.098 Millimoles per liter
Standard Deviation 0.8195
|
0.173 Millimoles per liter
Standard Deviation 0.9149
|
0.008 Millimoles per liter
Standard Deviation 1.0030
|
0.010 Millimoles per liter
Standard Deviation 1.1314
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 9
|
39.7 International units per liter
Standard Deviation 69.36
|
-5.7 International units per liter
Standard Deviation 18.29
|
63.9 International units per liter
Standard Deviation 126.80
|
15.8 International units per liter
Standard Deviation 29.26
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 14
|
-5.4 International units per liter
Standard Deviation 15.88
|
-10.8 International units per liter
Standard Deviation 20.17
|
-3.3 International units per liter
Standard Deviation 16.67
|
-8.1 International units per liter
Standard Deviation 15.00
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 9
|
1.9 International units per liter
Standard Deviation 13.49
|
-11.6 International units per liter
Standard Deviation 12.66
|
0.0 International units per liter
Standard Deviation 6.78
|
4.0 International units per liter
Standard Deviation 9.72
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 8
|
-2.1 International units per liter
Standard Deviation 4.76
|
-0.9 International units per liter
Standard Deviation 6.65
|
-2.5 International units per liter
Standard Deviation 4.90
|
2.0 International units per liter
Standard Deviation 8.06
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 9
|
0.7 International units per liter
Standard Deviation 6.09
|
-0.9 International units per liter
Standard Deviation 2.34
|
-0.6 International units per liter
Standard Deviation 2.24
|
3.8 International units per liter
Standard Deviation 9.87
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALT, Day 14
|
-2.3 International units per liter
Standard Deviation 5.67
|
0.6 International units per liter
Standard Deviation 8.68
|
-1.6 International units per liter
Standard Deviation 6.24
|
1.7 International units per liter
Standard Deviation 4.19
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 8
|
-2.2 International units per liter
Standard Deviation 7.77
|
-0.7 International units per liter
Standard Deviation 4.55
|
-1.2 International units per liter
Standard Deviation 4.94
|
-1.7 International units per liter
Standard Deviation 4.71
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 9
|
-3.6 International units per liter
Standard Deviation 7.29
|
-0.1 International units per liter
Standard Deviation 5.82
|
2.1 International units per liter
Standard Deviation 5.84
|
1.1 International units per liter
Standard Deviation 3.63
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
ALP, Day 14
|
-1.8 International units per liter
Standard Deviation 6.18
|
-1.1 International units per liter
Standard Deviation 7.33
|
0.5 International units per liter
Standard Deviation 6.83
|
-2.0 International units per liter
Standard Deviation 6.55
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 8
|
-1.6 International units per liter
Standard Deviation 3.66
|
0.0 International units per liter
Standard Deviation 11.09
|
-1.9 International units per liter
Standard Deviation 2.49
|
-0.2 International units per liter
Standard Deviation 3.73
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 9
|
0.9 International units per liter
Standard Deviation 2.38
|
-0.3 International units per liter
Standard Deviation 1.62
|
0.7 International units per liter
Standard Deviation 2.40
|
1.1 International units per liter
Standard Deviation 3.98
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
AST, Day 14
|
-1.5 International units per liter
Standard Deviation 3.42
|
-0.7 International units per liter
Standard Deviation 4.26
|
-1.2 International units per liter
Standard Deviation 3.36
|
0.0 International units per liter
Standard Deviation 3.11
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 8
|
-0.5 International units per liter
Standard Deviation 2.42
|
-1.0 International units per liter
Standard Deviation 2.44
|
-0.7 International units per liter
Standard Deviation 1.85
|
-0.1 International units per liter
Standard Deviation 3.51
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 9
|
-0.1 International units per liter
Standard Deviation 1.97
|
-0.4 International units per liter
Standard Deviation 1.03
|
0.3 International units per liter
Standard Deviation 1.22
|
0.3 International units per liter
Standard Deviation 0.67
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
GGT, Day 14
|
-1.0 International units per liter
Standard Deviation 3.23
|
-1.3 International units per liter
Standard Deviation 2.74
|
-0.8 International units per liter
Standard Deviation 2.33
|
-1.3 International units per liter
Standard Deviation 4.28
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 8
|
-18.9 International units per liter
Standard Deviation 24.04
|
28.2 International units per liter
Standard Deviation 446.48
|
-31.7 International units per liter
Standard Deviation 89.14
|
-45.0 International units per liter
Standard Deviation 97.35
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Creatine kinase, Day 14
|
8.8 International units per liter
Standard Deviation 90.46
|
-30.8 International units per liter
Standard Deviation 80.07
|
-22.5 International units per liter
Standard Deviation 88.70
|
-22.0 International units per liter
Standard Deviation 100.57
|
|
Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase
Lactate dehydrogenase, Day 8
|
-11.2 International units per liter
Standard Deviation 15.99
|
-12.5 International units per liter
Standard Deviation 20.51
|
-11.9 International units per liter
Standard Deviation 14.29
|
-13.4 International units per liter
Standard Deviation 17.89
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 14
|
-4.1 Micromoles per liter
Standard Deviation 30.40
|
-6.3 Micromoles per liter
Standard Deviation 28.01
|
-4.6 Micromoles per liter
Standard Deviation 36.43
|
-15.7 Micromoles per liter
Standard Deviation 26.94
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 9
|
-0.52 Micromoles per liter
Standard Deviation 3.082
|
1.21 Micromoles per liter
Standard Deviation 2.806
|
1.10 Micromoles per liter
Standard Deviation 3.561
|
-0.07 Micromoles per liter
Standard Deviation 2.873
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 8
|
-0.03 Micromoles per liter
Standard Deviation 5.326
|
7.07 Micromoles per liter
Standard Deviation 7.515
|
-1.15 Micromoles per liter
Standard Deviation 6.209
|
1.74 Micromoles per liter
Standard Deviation 5.394
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 9
|
1.59 Micromoles per liter
Standard Deviation 7.022
|
3.23 Micromoles per liter
Standard Deviation 4.312
|
-0.48 Micromoles per liter
Standard Deviation 7.226
|
2.13 Micromoles per liter
Standard Deviation 6.927
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Creatinine, Day 14
|
0.67 Micromoles per liter
Standard Deviation 6.049
|
2.71 Micromoles per liter
Standard Deviation 5.478
|
-0.37 Micromoles per liter
Standard Deviation 5.890
|
1.30 Micromoles per liter
Standard Deviation 4.255
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 8
|
-6.0 Micromoles per liter
Standard Deviation 31.24
|
2.7 Micromoles per liter
Standard Deviation 23.18
|
-8.1 Micromoles per liter
Standard Deviation 27.06
|
-23.4 Micromoles per liter
Standard Deviation 26.58
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Urate, Day 9
|
-4.7 Micromoles per liter
Standard Deviation 12.04
|
13.4 Micromoles per liter
Standard Deviation 24.46
|
17.7 Micromoles per liter
Standard Deviation 16.53
|
-17.1 Micromoles per liter
Standard Deviation 24.15
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 8
|
-2.15 Micromoles per liter
Standard Deviation 3.823
|
-1.16 Micromoles per liter
Standard Deviation 2.946
|
-0.17 Micromoles per liter
Standard Deviation 3.235
|
-0.06 Micromoles per liter
Standard Deviation 3.984
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Total Bilirubin, Day 14
|
-0.65 Micromoles per liter
Standard Deviation 2.832
|
1.36 Micromoles per liter
Standard Deviation 3.546
|
1.54 Micromoles per liter
Standard Deviation 3.563
|
0.01 Micromoles per liter
Standard Deviation 3.193
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 8
|
-0.33 Micromoles per liter
Standard Deviation 0.621
|
-0.17 Micromoles per liter
Standard Deviation 0.581
|
-0.06 Micromoles per liter
Standard Deviation 0.578
|
0.14 Micromoles per liter
Standard Deviation 0.821
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 9
|
-0.12 Micromoles per liter
Standard Deviation 0.512
|
0.15 Micromoles per liter
Standard Deviation 0.589
|
0.19 Micromoles per liter
Standard Deviation 0.625
|
0.22 Micromoles per liter
Standard Deviation 0.503
|
|
Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin
Direct Bilirubin, Day 14
|
-0.12 Micromoles per liter
Standard Deviation 0.492
|
0.14 Micromoles per liter
Standard Deviation 0.582
|
0.19 Micromoles per liter
Standard Deviation 0.618
|
0.00 Micromoles per liter
Standard Deviation 0.582
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Total protein, Day 8
|
-3.1 Grams per liter
Standard Deviation 4.31
|
-2.1 Grams per liter
Standard Deviation 3.86
|
-1.8 Grams per liter
Standard Deviation 3.38
|
-2.2 Grams per liter
Standard Deviation 3.45
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Albumin, Day 8
|
-2.5 Grams per liter
Standard Deviation 3.00
|
-2.0 Grams per liter
Standard Deviation 2.58
|
-1.6 Grams per liter
Standard Deviation 1.89
|
-2.2 Grams per liter
Standard Deviation 2.05
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Albumin, Day 9
|
0.4 Grams per liter
Standard Deviation 2.07
|
-0.5 Grams per liter
Standard Deviation 3.14
|
1.1 Grams per liter
Standard Deviation 2.15
|
0.7 Grams per liter
Standard Deviation 2.45
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Albumin, Day 14
|
-0.9 Grams per liter
Standard Deviation 2.82
|
-1.2 Grams per liter
Standard Deviation 2.32
|
0.1 Grams per liter
Standard Deviation 2.72
|
-2.3 Grams per liter
Standard Deviation 2.21
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Globulin, Day 8
|
-0.6 Grams per liter
Standard Deviation 1.80
|
-0.1 Grams per liter
Standard Deviation 1.96
|
-0.2 Grams per liter
Standard Deviation 2.12
|
-0.1 Grams per liter
Standard Deviation 1.96
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Globulin, Day 9
|
0.0 Grams per liter
Standard Deviation 2.11
|
-0.5 Grams per liter
Standard Deviation 2.38
|
0.4 Grams per liter
Standard Deviation 1.94
|
0.0 Grams per liter
Standard Deviation 1.63
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Globulin, Day 14
|
-0.4 Grams per liter
Standard Deviation 1.99
|
0.1 Grams per liter
Standard Deviation 1.88
|
0.6 Grams per liter
Standard Deviation 1.70
|
-0.2 Grams per liter
Standard Deviation 1.46
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Total protein, Day 9
|
0.4 Grams per liter
Standard Deviation 3.86
|
-0.9 Grams per liter
Standard Deviation 5.19
|
1.6 Grams per liter
Standard Deviation 3.91
|
0.7 Grams per liter
Standard Deviation 3.95
|
|
Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein
Total protein, Day 14
|
-1.3 Grams per liter
Standard Deviation 4.32
|
-1.1 Grams per liter
Standard Deviation 3.41
|
0.7 Grams per liter
Standard Deviation 4.05
|
-2.6 Grams per liter
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated timepoints to analyze amylase, lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Amylase, Day 8
|
-0.8 Units per liter
Standard Deviation 9.90
|
-0.1 Units per liter
Standard Deviation 11.55
|
-3.6 Units per liter
Standard Deviation 11.84
|
-2.5 Units per liter
Standard Deviation 10.69
|
|
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Amylase, Day 9
|
3.1 Units per liter
Standard Deviation 7.87
|
2.1 Units per liter
Standard Deviation 7.61
|
-1.0 Units per liter
Standard Deviation 7.09
|
0.4 Units per liter
Standard Deviation 2.84
|
|
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Amylase, Day 14
|
-2.3 Units per liter
Standard Deviation 7.59
|
-0.7 Units per liter
Standard Deviation 9.91
|
-4.1 Units per liter
Standard Deviation 16.30
|
-2.3 Units per liter
Standard Deviation 11.00
|
|
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Lipase, Day 8
|
4.4 Units per liter
Standard Deviation 27.20
|
-0.7 Units per liter
Standard Deviation 7.57
|
-1.5 Units per liter
Standard Deviation 9.36
|
-3.0 Units per liter
Standard Deviation 9.31
|
|
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Lipase, Day 9
|
0.9 Units per liter
Standard Deviation 3.63
|
-0.9 Units per liter
Standard Deviation 5.28
|
0.2 Units per liter
Standard Deviation 5.52
|
1.7 Units per liter
Standard Deviation 3.86
|
|
Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase
Lipase, Day 14
|
-1.5 Units per liter
Standard Deviation 5.66
|
-0.5 Units per liter
Standard Deviation 7.71
|
-1.8 Units per liter
Standard Deviation 8.08
|
-2.6 Units per liter
Standard Deviation 9.97
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Baseline (Day -2)
|
1.0152 Ratio
Standard Deviation 0.00779
|
1.0153 Ratio
Standard Deviation 0.00930
|
1.0167 Ratio
Standard Deviation 0.00894
|
1.0161 Ratio
Standard Deviation 0.00850
|
|
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 8
|
1.0180 Ratio
Standard Deviation 0.00761
|
1.0164 Ratio
Standard Deviation 0.00846
|
1.0179 Ratio
Standard Deviation 0.00767
|
1.0188 Ratio
Standard Deviation 0.00590
|
|
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 9
|
1.0189 Ratio
Standard Deviation 0.00973
|
1.0219 Ratio
Standard Deviation 0.00762
|
1.0179 Ratio
Standard Deviation 0.00595
|
1.0136 Ratio
Standard Deviation 0.00840
|
|
Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity
Day 14
|
1.0165 Ratio
Standard Deviation 0.00779
|
1.0170 Ratio
Standard Deviation 0.00804
|
1.0165 Ratio
Standard Deviation 0.00782
|
1.0175 Ratio
Standard Deviation 0.00872
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Urinalysis Parameter: pH
Day 9
|
5.75 pH
Standard Deviation 0.264
|
5.91 pH
Standard Deviation 0.625
|
6.06 pH
Standard Deviation 0.527
|
6.20 pH
Standard Deviation 0.483
|
|
Part 2: Absolute Values for Urinalysis Parameter: pH
Baseline (Day -2)
|
6.10 pH
Standard Deviation 0.386
|
6.19 pH
Standard Deviation 0.574
|
6.09 pH
Standard Deviation 0.479
|
6.13 pH
Standard Deviation 0.596
|
|
Part 2: Absolute Values for Urinalysis Parameter: pH
Day 8
|
5.90 pH
Standard Deviation 0.327
|
5.88 pH
Standard Deviation 0.415
|
5.98 pH
Standard Deviation 0.302
|
6.02 pH
Standard Deviation 0.278
|
|
Part 2: Absolute Values for Urinalysis Parameter: pH
Day 14
|
6.00 pH
Standard Deviation 0.491
|
6.00 pH
Standard Deviation 0.378
|
6.13 pH
Standard Deviation 0.447
|
6.12 pH
Standard Deviation 0.475
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 8
|
0.0034 Ratio
Standard Deviation 0.00849
|
0.0030 Ratio
Standard Deviation 0.00875
|
0.0019 Ratio
Standard Deviation 0.00727
|
0.0026 Ratio
Standard Deviation 0.01037
|
|
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 9
|
0.0015 Ratio
Standard Deviation 0.00619
|
0.0015 Ratio
Standard Deviation 0.00708
|
-0.0011 Ratio
Standard Deviation 0.01080
|
-0.0020 Ratio
Standard Deviation 0.00850
|
|
Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity
Day 14
|
0.0022 Ratio
Standard Deviation 0.00747
|
0.0037 Ratio
Standard Deviation 0.00838
|
0.0005 Ratio
Standard Deviation 0.00922
|
0.0016 Ratio
Standard Deviation 0.01055
|
SECONDARY outcome
Timeframe: Baseline (Day -2), Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at specified time points were analyzed.
Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in Urinalysis Parameter: pH
Day 8
|
-0.19 pH
Standard Deviation 0.441
|
-0.33 pH
Standard Deviation 0.539
|
-0.08 pH
Standard Deviation 0.389
|
-0.18 pH
Standard Deviation 0.676
|
|
Part 2: Change From Baseline in Urinalysis Parameter: pH
Day 9
|
-0.35 pH
Standard Deviation 0.337
|
-0.23 pH
Standard Deviation 0.344
|
-0.11 pH
Standard Deviation 0.546
|
0.30 pH
Standard Deviation 0.350
|
|
Part 2: Change From Baseline in Urinalysis Parameter: pH
Day 14
|
-0.13 pH
Standard Deviation 0.490
|
-0.21 pH
Standard Deviation 0.590
|
0.06 pH
Standard Deviation 0.442
|
-0.09 pH
Standard Deviation 0.708
|
SECONDARY outcome
Timeframe: Baseline(Day-2), Day1: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 2: 24 Hours, Day 4: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, Day 5: 24 Hours; Day 7: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 8: 24 Hours; Day 9 and Day 14Population: Safety Population.
A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. 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 clinically significant abnormal 12-Lead ECG findings has reported.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 1: 6 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Baseline (Day -2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 1: 1 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 1: 2 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 1: 3 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 1: 4 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 2: 24 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 4: 1 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 4: 2 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 4: 3 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 4: 4 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 4: 6 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 5: 24 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 7: 1 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 7: 2 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 7: 3 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 7: 4 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 7: 6 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 8: 24 Hours
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings
Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Baseline (Pre-dose, Day 1)
|
106.0 Millimeters of mercury
Standard Deviation 9.39
|
106.7 Millimeters of mercury
Standard Deviation 11.69
|
106.8 Millimeters of mercury
Standard Deviation 9.03
|
105.4 Millimeters of mercury
Standard Deviation 9.79
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 2
|
103.9 Millimeters of mercury
Standard Deviation 8.18
|
104.5 Millimeters of mercury
Standard Deviation 9.05
|
105.6 Millimeters of mercury
Standard Deviation 9.78
|
105.7 Millimeters of mercury
Standard Deviation 10.10
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 3
|
104.3 Millimeters of mercury
Standard Deviation 9.82
|
103.8 Millimeters of mercury
Standard Deviation 8.53
|
105.1 Millimeters of mercury
Standard Deviation 9.41
|
105.3 Millimeters of mercury
Standard Deviation 11.30
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 4
|
103.1 Millimeters of mercury
Standard Deviation 9.37
|
103.5 Millimeters of mercury
Standard Deviation 11.25
|
105.3 Millimeters of mercury
Standard Deviation 8.73
|
105.7 Millimeters of mercury
Standard Deviation 10.05
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 5
|
105.7 Millimeters of mercury
Standard Deviation 9.50
|
103.3 Millimeters of mercury
Standard Deviation 10.24
|
103.7 Millimeters of mercury
Standard Deviation 8.65
|
106.8 Millimeters of mercury
Standard Deviation 8.82
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 6
|
105.2 Millimeters of mercury
Standard Deviation 8.80
|
104.7 Millimeters of mercury
Standard Deviation 8.60
|
105.7 Millimeters of mercury
Standard Deviation 8.42
|
108.4 Millimeters of mercury
Standard Deviation 9.44
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 7
|
107.6 Millimeters of mercury
Standard Deviation 10.34
|
106.7 Millimeters of mercury
Standard Deviation 9.23
|
107.4 Millimeters of mercury
Standard Deviation 8.68
|
107.4 Millimeters of mercury
Standard Deviation 7.90
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 8
|
109.9 Millimeters of mercury
Standard Deviation 9.03
|
108.1 Millimeters of mercury
Standard Deviation 9.40
|
109.4 Millimeters of mercury
Standard Deviation 8.95
|
109.1 Millimeters of mercury
Standard Deviation 9.24
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
,SBP, Day 9
|
115.9 Millimeters of mercury
Standard Deviation 9.72
|
104.2 Millimeters of mercury
Standard Deviation 11.58
|
109.0 Millimeters of mercury
Standard Deviation 7.48
|
105.8 Millimeters of mercury
Standard Deviation 8.61
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
SBP, Day 14
|
105.6 Millimeters of mercury
Standard Deviation 9.51
|
108.0 Millimeters of mercury
Standard Deviation 10.02
|
107.8 Millimeters of mercury
Standard Deviation 9.38
|
106.3 Millimeters of mercury
Standard Deviation 10.43
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Baseline (Pre-dose, Day 1)
|
61.1 Millimeters of mercury
Standard Deviation 7.04
|
60.9 Millimeters of mercury
Standard Deviation 6.61
|
62.1 Millimeters of mercury
Standard Deviation 7.12
|
61.4 Millimeters of mercury
Standard Deviation 6.18
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 2
|
59.6 Millimeters of mercury
Standard Deviation 6.27
|
59.3 Millimeters of mercury
Standard Deviation 6.32
|
60.9 Millimeters of mercury
Standard Deviation 6.65
|
60.9 Millimeters of mercury
Standard Deviation 6.10
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 3
|
60.9 Millimeters of mercury
Standard Deviation 7.26
|
60.0 Millimeters of mercury
Standard Deviation 7.46
|
61.0 Millimeters of mercury
Standard Deviation 7.23
|
63.0 Millimeters of mercury
Standard Deviation 7.80
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 4
|
59.8 Millimeters of mercury
Standard Deviation 7.61
|
60.0 Millimeters of mercury
Standard Deviation 7.36
|
61.0 Millimeters of mercury
Standard Deviation 5.40
|
62.8 Millimeters of mercury
Standard Deviation 6.10
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 5
|
60.3 Millimeters of mercury
Standard Deviation 8.15
|
59.3 Millimeters of mercury
Standard Deviation 6.23
|
59.1 Millimeters of mercury
Standard Deviation 5.88
|
61.7 Millimeters of mercury
Standard Deviation 5.44
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 6
|
60.3 Millimeters of mercury
Standard Deviation 5.69
|
60.1 Millimeters of mercury
Standard Deviation 6.46
|
61.6 Millimeters of mercury
Standard Deviation 6.99
|
62.4 Millimeters of mercury
Standard Deviation 7.00
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 7
|
61.0 Millimeters of mercury
Standard Deviation 6.14
|
59.6 Millimeters of mercury
Standard Deviation 6.89
|
61.1 Millimeters of mercury
Standard Deviation 6.71
|
62.3 Millimeters of mercury
Standard Deviation 6.28
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 8
|
62.3 Millimeters of mercury
Standard Deviation 6.72
|
62.6 Millimeters of mercury
Standard Deviation 7.23
|
61.4 Millimeters of mercury
Standard Deviation 7.18
|
62.7 Millimeters of mercury
Standard Deviation 7.03
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 9
|
66.2 Millimeters of mercury
Standard Deviation 5.67
|
56.6 Millimeters of mercury
Standard Deviation 3.83
|
61.3 Millimeters of mercury
Standard Deviation 5.41
|
65.8 Millimeters of mercury
Standard Deviation 5.37
|
|
Part 2: Absolute Values for Vital Parameters: SBP and DBP
DBP, Day 14
|
61.6 Millimeters of mercury
Standard Deviation 7.86
|
62.8 Millimeters of mercury
Standard Deviation 6.65
|
61.8 Millimeters of mercury
Standard Deviation 6.47
|
61.2 Millimeters of mercury
Standard Deviation 6.91
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Baseline (Pre-dose, Day 1)
|
62.5 Beats per minute
Standard Deviation 9.32
|
60.4 Beats per minute
Standard Deviation 7.68
|
61.8 Beats per minute
Standard Deviation 9.46
|
61.0 Beats per minute
Standard Deviation 6.85
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 2
|
61.9 Beats per minute
Standard Deviation 8.37
|
62.4 Beats per minute
Standard Deviation 8.04
|
61.6 Beats per minute
Standard Deviation 7.22
|
63.2 Beats per minute
Standard Deviation 9.05
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 3
|
63.4 Beats per minute
Standard Deviation 9.67
|
63.0 Beats per minute
Standard Deviation 6.76
|
62.2 Beats per minute
Standard Deviation 6.46
|
63.9 Beats per minute
Standard Deviation 7.81
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 4
|
63.4 Beats per minute
Standard Deviation 8.59
|
63.0 Beats per minute
Standard Deviation 7.38
|
63.5 Beats per minute
Standard Deviation 7.88
|
64.5 Beats per minute
Standard Deviation 7.76
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 5
|
64.4 Beats per minute
Standard Deviation 8.57
|
62.4 Beats per minute
Standard Deviation 7.52
|
63.3 Beats per minute
Standard Deviation 8.32
|
66.0 Beats per minute
Standard Deviation 7.08
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 6
|
62.0 Beats per minute
Standard Deviation 6.87
|
63.0 Beats per minute
Standard Deviation 7.17
|
63.7 Beats per minute
Standard Deviation 8.89
|
66.5 Beats per minute
Standard Deviation 7.13
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 7
|
63.4 Beats per minute
Standard Deviation 7.36
|
61.6 Beats per minute
Standard Deviation 6.77
|
62.7 Beats per minute
Standard Deviation 7.40
|
65.8 Beats per minute
Standard Deviation 7.40
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 8
|
63.9 Beats per minute
Standard Deviation 8.98
|
63.9 Beats per minute
Standard Deviation 6.75
|
63.9 Beats per minute
Standard Deviation 7.21
|
65.7 Beats per minute
Standard Deviation 6.92
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 9
|
69.2 Beats per minute
Standard Deviation 7.48
|
66.8 Beats per minute
Standard Deviation 8.89
|
70.3 Beats per minute
Standard Deviation 12.72
|
70.4 Beats per minute
Standard Deviation 10.19
|
|
Part 2: Absolute Values for Vital Parameter: Pulse Rate
Day 14
|
63.6 Beats per minute
Standard Deviation 9.47
|
63.6 Beats per minute
Standard Deviation 8.18
|
63.6 Beats per minute
Standard Deviation 6.49
|
61.1 Beats per minute
Standard Deviation 7.33
|
SECONDARY outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, and Day 14Population: Safety Population. Only those participants with data available at the indicated time points were analyzed.
Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=42 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=40 Participants
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 Participants
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 11
|
36.05 Degrees Celsius
Standard Deviation 0.276
|
36.22 Degrees Celsius
Standard Deviation 0.333
|
36.28 Degrees Celsius
Standard Deviation 0.397
|
36.19 Degrees Celsius
Standard Deviation 0.327
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 12
|
36.10 Degrees Celsius
Standard Deviation 0.350
|
36.14 Degrees Celsius
Standard Deviation 0.285
|
36.26 Degrees Celsius
Standard Deviation 0.333
|
36.07 Degrees Celsius
Standard Deviation 0.333
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 13
|
36.12 Degrees Celsius
Standard Deviation 0.327
|
36.25 Degrees Celsius
Standard Deviation 0.314
|
36.20 Degrees Celsius
Standard Deviation 0.308
|
36.21 Degrees Celsius
Standard Deviation 0.397
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 14
|
36.25 Degrees Celsius
Standard Deviation 0.261
|
36.31 Degrees Celsius
Standard Deviation 0.328
|
36.36 Degrees Celsius
Standard Deviation 0.224
|
36.31 Degrees Celsius
Standard Deviation 0.368
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 7
|
36.20 Degrees Celsius
Standard Deviation 0.315
|
36.19 Degrees Celsius
Standard Deviation 0.303
|
36.22 Degrees Celsius
Standard Deviation 0.310
|
36.22 Degrees Celsius
Standard Deviation 0.305
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Baseline (Pre-dose, Day 1)
|
36.25 Degrees Celsius
Standard Deviation 0.304
|
36.28 Degrees Celsius
Standard Deviation 0.335
|
36.22 Degrees Celsius
Standard Deviation 0.379
|
36.32 Degrees Celsius
Standard Deviation 0.303
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 1
|
36.14 Degrees Celsius
Standard Deviation 0.302
|
36.29 Degrees Celsius
Standard Deviation 0.313
|
36.25 Degrees Celsius
Standard Deviation 0.245
|
36.21 Degrees Celsius
Standard Deviation 0.378
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 2
|
36.22 Degrees Celsius
Standard Deviation 0.333
|
36.17 Degrees Celsius
Standard Deviation 0.266
|
36.18 Degrees Celsius
Standard Deviation 0.309
|
36.18 Degrees Celsius
Standard Deviation 0.331
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 3
|
36.20 Degrees Celsius
Standard Deviation 0.449
|
36.09 Degrees Celsius
Standard Deviation 0.283
|
36.14 Degrees Celsius
Standard Deviation 0.353
|
36.15 Degrees Celsius
Standard Deviation 0.344
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 4
|
36.21 Degrees Celsius
Standard Deviation 0.378
|
36.13 Degrees Celsius
Standard Deviation 0.353
|
36.18 Degrees Celsius
Standard Deviation 0.288
|
36.23 Degrees Celsius
Standard Deviation 0.344
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 5
|
36.26 Degrees Celsius
Standard Deviation 0.407
|
36.08 Degrees Celsius
Standard Deviation 0.326
|
36.16 Degrees Celsius
Standard Deviation 0.272
|
36.18 Degrees Celsius
Standard Deviation 0.289
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 6
|
36.21 Degrees Celsius
Standard Deviation 0.364
|
36.21 Degrees Celsius
Standard Deviation 0.393
|
36.17 Degrees Celsius
Standard Deviation 0.320
|
36.16 Degrees Celsius
Standard Deviation 0.304
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 8
|
36.28 Degrees Celsius
Standard Deviation 0.368
|
36.25 Degrees Celsius
Standard Deviation 0.312
|
36.32 Degrees Celsius
Standard Deviation 0.344
|
36.34 Degrees Celsius
Standard Deviation 0.271
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 9
|
36.16 Degrees Celsius
Standard Deviation 0.431
|
36.18 Degrees Celsius
Standard Deviation 0.363
|
36.23 Degrees Celsius
Standard Deviation 0.327
|
36.12 Degrees Celsius
Standard Deviation 0.349
|
|
Part 2: Absolute Values for Vital Parameter: Temperature
Day 10
|
36.05 Degrees Celsius
Standard Deviation 0.353
|
36.10 Degrees Celsius
Standard Deviation 0.323
|
36.17 Degrees Celsius
Standard Deviation 0.296
|
36.13 Degrees Celsius
Standard Deviation 0.360
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dosePopulation: QT/QTc Population. Only those participants with data available at specified time points were analyzed.
Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value
Outcome measures
| Measure |
Part 1: GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1 : GSK3640254 500 mg
n=40 Participants
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day 7, Predose
|
2.7 Milliseconds
Interval 1.01 to 4.46
|
3.3 Milliseconds
Interval 1.61 to 5.01
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 0.5 Hour Post-dose
|
-1.9 Milliseconds
Interval -3.75 to 0.02
|
-2.1 Milliseconds
Interval -3.98 to -0.19
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day 7, 1 Hour Post-dose
|
-0.3 Milliseconds
Interval -2.22 to 1.68
|
-1.1 Milliseconds
Interval -3.04 to 0.88
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day 7, 2 Hour Post-dose
|
-3.9 Milliseconds
Interval -6.09 to -1.76
|
1.7 Milliseconds
Interval -0.53 to 3.85
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day 7, 3 Hour Post-dose
|
-4.3 Milliseconds
Interval -6.48 to -2.18
|
3.6 Milliseconds
Interval 1.44 to 5.77
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 3.5 Hour Post-dose
|
-4.4 Milliseconds
Interval -6.33 to -2.38
|
4.5 Milliseconds
Interval 2.55 to 6.5
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 4 Hour Post-dose
|
-3.0 Milliseconds
Interval -4.88 to -1.14
|
5.6 Milliseconds
Interval 3.75 to 7.5
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 4.5 Hour Post-dose
|
-2.6 Milliseconds
Interval -4.57 to -0.53
|
5.9 Milliseconds
Interval 3.83 to 7.87
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 5 Hour Post-dose
|
-1.3 Milliseconds
Interval -3.19 to 0.64
|
6.9 Milliseconds
Interval 4.97 to 8.8
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 6 Hour Post-dose
|
-2.9 Milliseconds
Interval -5.25 to -0.52
|
5.3 Milliseconds
Interval 2.98 to 7.69
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 8 Hour Post-dose
|
-7.7 Milliseconds
Interval -9.67 to -5.7
|
-0.8 Milliseconds
Interval -2.72 to 1.21
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 10 Hour Post-dose
|
-4.2 Milliseconds
Interval -6.05 to -2.4
|
2.6 Milliseconds
Interval 0.76 to 4.37
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 12 Hour Post-dose
|
-2.0 Milliseconds
Interval -4.12 to 0.1
|
3.3 Milliseconds
Interval 1.19 to 5.33
|
—
|
—
|
|
Part 2: Change From Baseline in QTcF - For Placebo and Moxifloxacin Arm
Day7, 24 Hour Post-dose
|
-0.6 Milliseconds
Interval -2.57 to 1.39
|
6.2 Milliseconds
Interval 4.28 to 8.21
|
—
|
—
|
Adverse Events
Part 1: Placebo
Part 1: GSK3640254 500 mg
Part 2: Placebo
Part 2: Moxifloxacin 400 mg
Part 2: GSK3640254 100 mg
Part 2: GSK3640254 500 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Placebo
n=2 participants at risk
Participants received a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal.
|
Part 1: GSK3640254 500 mg
n=6 participants at risk
Participants received single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
|
Part 2: Placebo
n=42 participants at risk
Participants received placebo matching GSK3640254 from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: Moxifloxacin 400 mg
n=40 participants at risk
Participants received placebo matching GSK3640254 from Days 1 through 6 and a single dose of Moxifloxacin 400 mg on Day 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 100 mg
n=40 participants at risk
Participants received therapeutic dose of GSK3640254 100 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
Part 2: GSK3640254 500 mg
n=40 participants at risk
Participants received supratherapeutic dose of GSK3640254 500 mg once daily from Days 1 through 7 in each Treatment Period of Part 2 of the study.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
16.7%
1/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
50.0%
1/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Nervous system disorders
Somnolence
|
50.0%
1/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
15.0%
6/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
5.0%
2/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
General disorders
Fatigue
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
5.0%
2/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
General disorders
Chills
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
5.0%
2/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.4%
1/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/6 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/42 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
2.5%
1/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
0.00%
0/40 • All-cause mortality, Serious adverse events (SAEs), and non-SAEs were collected up to Day 9 in Part 1 and up to Day 51 in Part 2 of the study
All cause mortality, SAEs and non-SAEs were reported for the Safety Population which comprised of all randomized participants who received at least 1 dose of study intervention. AE data has been presented treatment-wise and part-wise.
|
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