Trial Outcomes & Findings for GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers (NCT NCT03231943)
NCT ID: NCT03231943
Last Updated: 2021-06-10
Results Overview
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. Results are presented treatment wise.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
78 participants
Primary outcome timeframe
Up to Day 15
Results posted on
2021-06-10
Participant Flow
This study was conducted to evaluate safety, tolerability and pharmacokinetic (PK) of GSK3640254 in healthy participants at one center in United Kingdom from 19-September-2017 to 09-September-2018
Total 78 participants were enrolled in the study. This was a two part study, Part 1 was single ascending dose (SAD) and Part 2 was multiple ascending dose (MAD).
Participant milestones
| Measure |
Part 1: Placebo Followed by GSK3640254 10mg/100mg/400mg
Participants received single dose placebo followed by GSK3640254 10 milligram (mg) followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
|
Part 1: GSK3640254 1mg/ Placebo /100 mg/400 mg
Participants received single dose GSK3640254 1mg followed by placebo followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
|
Part 1: GSK3640254 1mg/10mg/Placebo /400mg
Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by placebo followed by GSK3640254 400 mg oral dose on Day 1
|
Part 1: GSK3640254 1mg/10mg/100mg/Placebo
Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by GSK3640254 100 mg followed by placebo as oral dose on Day 1
|
Part 1: Placebo/ GSK3640254 30mg/200 mg/700 mg
Participants received single dose placebo followed by GSK3640254 30mg followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
|
Part1:GSK3640254 3mg/Placebo/200mg/700mg
Participants received single dose GSK3640254 3mg followed by placebo followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
|
Part 1:GSK3640254 3mg/30mg/Placebo/GSK3640254 700mg
Participants received single dose GSK3640254 3 mg followed by GSK3640254 30 mg followed by placebo followed by GSK3640254 700 mg as oral dose on Day 1
|
Part 1:GSK3640254 3mg/30mg/GSK3640254 200mg/Placebo
Participants received single dose GSK3640254 3mg followed by GSK3640254 30mg followed by GSK3640254 200mg followed by placebo as oral dose on Day 1
|
Part 2: Repeated Dose GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 100mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 2: GSK3640254 200mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 320mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
|
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 1, Period 1 (up to Day 15)
STARTED
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2
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2
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2
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2
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2
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2
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2
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2
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0
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0
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0
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Part 1, Period 1 (up to Day 15)
COMPLETED
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2
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2
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2
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2
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2
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2
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2
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2
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0
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0
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0
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0
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Part 1, Period 1 (up to Day 15)
NOT COMPLETED
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Part 1, Period 2 (up to Day 30)
STARTED
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2
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Part 1, Period 2 (up to Day 30)
COMPLETED
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2
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0
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1
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2
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2
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2
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2
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2
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0
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0
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Part 1, Period 2 (up to Day 30)
NOT COMPLETED
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0
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2
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1
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0
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Part 1, Period 3 (up to Day 45)
STARTED
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2
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2
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2
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2
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2
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2
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2
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2
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0
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Part 1, Period 3 (up to Day 45)
COMPLETED
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1
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2
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2
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2
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2
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2
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2
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2
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0
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0
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0
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0
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0
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Part 1, Period 3 (up to Day 45)
NOT COMPLETED
|
1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1 Period 4 (up to Day 60)
STARTED
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2
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2
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2
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2
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2
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2
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2
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2
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0
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0
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0
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Part 1 Period 4 (up to Day 60)
COMPLETED
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2
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2
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2
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2
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2
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2
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2
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2
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0
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0
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0
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0
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0
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Part 1 Period 4 (up to Day 60)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 2
STARTED
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0
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0
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0
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0
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0
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0
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0
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0
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6
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6
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25
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7
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14
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Part 2
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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6
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6
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24
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6
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14
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Part 2
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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1
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0
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Reasons for withdrawal
| Measure |
Part 1: Placebo Followed by GSK3640254 10mg/100mg/400mg
Participants received single dose placebo followed by GSK3640254 10 milligram (mg) followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
|
Part 1: GSK3640254 1mg/ Placebo /100 mg/400 mg
Participants received single dose GSK3640254 1mg followed by placebo followed by GSK3640254 100 mg followed by GSK3640254 400 mg oral dose on Day 1
|
Part 1: GSK3640254 1mg/10mg/Placebo /400mg
Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by placebo followed by GSK3640254 400 mg oral dose on Day 1
|
Part 1: GSK3640254 1mg/10mg/100mg/Placebo
Participants received single dose GSK3640254 1mg followed by GSK3640254 10 mg followed by GSK3640254 100 mg followed by placebo as oral dose on Day 1
|
Part 1: Placebo/ GSK3640254 30mg/200 mg/700 mg
Participants received single dose placebo followed by GSK3640254 30mg followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
|
Part1:GSK3640254 3mg/Placebo/200mg/700mg
Participants received single dose GSK3640254 3mg followed by placebo followed by GSK3640254 200 mg followed by GSK3640254 700 mg as oral dose on Day 1
|
Part 1:GSK3640254 3mg/30mg/Placebo/GSK3640254 700mg
Participants received single dose GSK3640254 3 mg followed by GSK3640254 30 mg followed by placebo followed by GSK3640254 700 mg as oral dose on Day 1
|
Part 1:GSK3640254 3mg/30mg/GSK3640254 200mg/Placebo
Participants received single dose GSK3640254 3mg followed by GSK3640254 30mg followed by GSK3640254 200mg followed by placebo as oral dose on Day 1
|
Part 2: Repeated Dose GSK3640254 50 mg
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 100mg
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 2: GSK3640254 200mg + Expansion
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 320mg
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
|
Part 2: Repeated Dose Placebo
Participants received repeated dose of matching placebo once daily up to 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1, Period 2 (up to Day 30)
Adverse Event
|
0
|
1
|
1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1, Period 2 (up to Day 30)
Withdrawal by Subject
|
0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1, Period 3 (up to Day 45)
Adverse Event
|
1
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0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 2
Adverse Event
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Part 2
Withdrawal by Subject
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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Baseline Characteristics
GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Part 1: Cohort 1
n=12 Participants
Participants received GSK3640254 1mg, GSK3640254 10 mg, GSK3640254 100mg, GSK3640254 400mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods
|
Part 1: Cohort 2
n=8 Participants
Participants received GSK3640254 3mg, GSK3640254 30 mg, GSK3640254 200mg, GSK3640254 700mg as ascending single dose on Day 1 of each period, each participant received placebo in one of the four periods
|
Part 2: Repeated Dose GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 200 mg + Expansion
n=25 Participants
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 320 mg
n=7 Participants
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
|
Part 2: Repeated Dose Placebo
n=14 Participants
Participants received repeated dose of matching placebo once daily up to 14 days
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
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Race/Ethnicity, Customized
WHITE-WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
61 Participants
n=40 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
78 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
78 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
ASIAN - CENTRAL/SOUTH ASIAN HERITAGE
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
ASIAN - EAST ASIAN HERITAGE
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
ASIAN - SOUTH EAST ASIAN HERITAGE
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
WHITE - ARABIC/NORTH AFRICAN HERITAGE
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to Day 15Population: Safety Population. It is comprised of all participants who received at least one dose of a study treatment.
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
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Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
AE
|
4 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
|
Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.002 10^9 cells /Liter
Standard Deviation 0.0098
|
-0.007 10^9 cells /Liter
Standard Deviation 0.0052
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0147
|
0.003 10^9 cells /Liter
Standard Deviation 0.0103
|
0.000 10^9 cells /Liter
Standard Deviation 0.0155
|
-0.003 10^9 cells /Liter
Standard Deviation 0.0103
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0147
|
-0.005 10^9 cells /Liter
Standard Deviation 0.0152
|
0.004 10^9 cells /Liter
Standard Deviation 0.0118
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 15,n=6,6,6,6,6,6,6,6,16
|
0.010 10^9 cells /Liter
Standard Deviation 0.0063
|
-0.005 10^9 cells /Liter
Standard Deviation 0.0207
|
-0.005 10^9 cells /Liter
Standard Deviation 0.0084
|
0.002 10^9 cells /Liter
Standard Deviation 0.0133
|
0.012 10^9 cells /Liter
Standard Deviation 0.0117
|
0.000 10^9 cells /Liter
Standard Deviation 0.0110
|
0.002 10^9 cells /Liter
Standard Deviation 0.0098
|
-0.007 10^9 cells /Liter
Standard Deviation 0.0082
|
0.007 10^9 cells /Liter
Standard Deviation 0.0178
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, 24 hours, n=6,6,6,6,6,6,5,6,16
|
0.002 10^9 cells /Liter
Standard Deviation 0.0098
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0148
|
-0.007 10^9 cells /Liter
Standard Deviation 0.0121
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0075
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0147
|
0.005 10^9 cells /Liter
Standard Deviation 0.0084
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0075
|
-0.007 10^9 cells /Liter
Standard Deviation 0.0103
|
0.001 10^9 cells /Liter
Standard Deviation 0.0106
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, 48 hours, n=6,6,5,6,6,6,6,6,16
|
0.007 10^9 cells /Liter
Standard Deviation 0.0082
|
0.000 10^9 cells /Liter
Standard Deviation 0.0167
|
0.000 10^9 cells /Liter
Standard Deviation 0.0110
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0098
|
0.012 10^9 cells /Liter
Standard Deviation 0.0117
|
0.010 10^9 cells /Liter
Standard Deviation 0.0187
|
-0.007 10^9 cells /Liter
Standard Deviation 0.0103
|
-0.005 10^9 cells /Liter
Standard Deviation 0.00550
|
0.005 10^9 cells /Liter
Standard Deviation 0.0115
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, 24 hours, n=6,6,6,6,6,6,5,6,16
|
-0.017 10^9 cells /Liter
Standard Deviation 0.0186
|
-0.032 10^9 cells /Liter
Standard Deviation 0.0642
|
0.023 10^9 cells /Liter
Standard Deviation 0.0266
|
-0.022 10^9 cells /Liter
Standard Deviation 0.1876
|
0.012 10^9 cells /Liter
Standard Deviation 0.0376
|
0.005 10^9 cells /Liter
Standard Deviation 0.0650
|
0.015 10^9 cells /Liter
Standard Deviation 0.0489
|
0.008 10^9 cells /Liter
Standard Deviation 0.0508
|
0.005 10^9 cells /Liter
Standard Deviation 0.0648
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, 48 hour, 6,6,5,6,6,6,6,6,16
|
0.020 10^9 cells /Liter
Standard Deviation 0.0346
|
-0.030 10^9 cells /Liter
Standard Deviation 0.0443
|
0.012 10^9 cells /Liter
Standard Deviation 0.0796
|
-0.032 10^9 cells /Liter
Standard Deviation 0.1982
|
0.018 10^9 cells /Liter
Standard Deviation 0.0731
|
0.008 10^9 cells /Liter
Standard Deviation 0.0497
|
0.010 10^9 cells /Liter
Standard Deviation 0.0544
|
0.010 10^9 cells /Liter
Standard Deviation 0.0544
|
0.037 10^9 cells /Liter
Standard Deviation 0.0266
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-0.018 10^9 cells /Liter
Standard Deviation 0.0382
|
0.028 10^9 cells /Liter
Standard Deviation 0.0861
|
0.022 10^9 cells /Liter
Standard Deviation 0.0256
|
-0.052 10^9 cells /Liter
Standard Deviation 0.1970
|
0.035 10^9 cells /Liter
Standard Deviation 0.0575
|
-0.012 10^9 cells /Liter
Standard Deviation 0.0591
|
0.003 10^9 cells /Liter
Standard Deviation 0.0602
|
0.013 10^9 cells /Liter
Standard Deviation 0.0207
|
0.013 10^9 cells /Liter
Standard Deviation 0.0656
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.012 10^9 cells /Liter
Standard Deviation 0.0471
|
-0.032 10^9 cells /Liter
Standard Deviation 0.0960
|
-0.012 10^9 cells /Liter
Standard Deviation 0.0354
|
-0.023 10^9 cells /Liter
Standard Deviation 0.1328
|
0.012 10^9 cells /Liter
Standard Deviation 0.0534
|
0.000 10^9 cells /Liter
Standard Deviation 0.0335
|
0.020 10^9 cells /Liter
Standard Deviation 0.0921
|
0.018 10^9 cells /Liter
Standard Deviation 0.0542
|
-0.015 10^9 cells /Liter
Standard Deviation 0.0791
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, 24 hours, n=6,6,6,6,6,6,5,6,16
|
-0.742 10^9 cells /Liter
Standard Deviation 2.2552
|
-0.088 10^9 cells /Liter
Standard Deviation 0.4219
|
0.078 10^9 cells /Liter
Standard Deviation 0.6916
|
0.592 10^9 cells /Liter
Standard Deviation 0.9839
|
0.877 10^9 cells /Liter
Standard Deviation 0.7228
|
-0.910 10^9 cells /Liter
Standard Deviation 1.1691
|
0.058 10^9 cells /Liter
Standard Deviation 0.8437
|
0.132 10^9 cells /Liter
Standard Deviation 0.8528
|
0.079 10^9 cells /Liter
Standard Deviation 0.8700
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, 48 hours, n=6,6,5,6,6,6,6,6,16
|
-0.673 10^9 cells /Liter
Standard Deviation 1.8656
|
1.220 10^9 cells /Liter
Standard Deviation 2.6559
|
0.312 10^9 cells /Liter
Standard Deviation 0.6725
|
0.603 10^9 cells /Liter
Standard Deviation 1.3012
|
0.388 10^9 cells /Liter
Standard Deviation 0.8506
|
-0.878 10^9 cells /Liter
Standard Deviation 1.2611
|
-0.292 10^9 cells /Liter
Standard Deviation 0.9476
|
0.307 10^9 cells /Liter
Standard Deviation 1.1555
|
0.104 10^9 cells /Liter
Standard Deviation 0.8442
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes 96 hours, n=6,6,6,6,6,6,6,6,15
|
-0.458 10^9 cells /Liter
Standard Deviation 2.3501
|
0.390 10^9 cells /Liter
Standard Deviation 1.3833
|
0.557 10^9 cells /Liter
Standard Deviation 0.5838
|
0.693 10^9 cells /Liter
Standard Deviation 1.1514
|
0.953 10^9 cells /Liter
Standard Deviation 0.8659
|
-0.897 10^9 cells /Liter
Standard Deviation 0.9192
|
-0.107 10^9 cells /Liter
Standard Deviation 0.9821
|
0.503 10^9 cells /Liter
Standard Deviation 1.1885
|
0.272 10^9 cells /Liter
Standard Deviation 0.8542
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.835 10^9 cells /Liter
Standard Deviation 1.6488
|
-0.142 10^9 cells /Liter
Standard Deviation 1.5163
|
0.327 10^9 cells /Liter
Standard Deviation 0.9991
|
0.348 10^9 cells /Liter
Standard Deviation 1.0652
|
0.502 10^9 cells /Liter
Standard Deviation 1.2216
|
-0.113 10^9 cells /Liter
Standard Deviation 1.8444
|
-0.007 10^9 cells /Liter
Standard Deviation 1.0958
|
0.292 10^9 cells /Liter
Standard Deviation 0.6240
|
-0.111 10^9 cells /Liter
Standard Deviation 0.7964
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, 24 hours, n=6,6,6,6,6,6,5,6,16
|
-0.158 10^9 cells /Liter
Standard Deviation 0.1659
|
-0.124 10^9 cells /Liter
Standard Deviation 0.0727
|
-0.005 10^9 cells /Liter
Standard Deviation 0.2375
|
0.073 10^9 cells /Liter
Standard Deviation 0.3189
|
0.243 10^9 cells /Liter
Standard Deviation 0.1888
|
-0.248 10^9 cells /Liter
Standard Deviation 0.3124
|
-0.140 10^9 cells /Liter
Standard Deviation 0.2305
|
-0.188 10^9 cells /Liter
Standard Deviation 0.3172
|
0.027 10^9 cells /Liter
Standard Deviation 0.2972
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, 48 hours, n=6,6,5,6,6,6,6,6,16
|
-0.110 10^9 cells /Liter
Standard Deviation 0.2873
|
-0.303 10^9 cells /Liter
Standard Deviation 0.4113
|
0.082 10^9 cells /Liter
Standard Deviation 0.2490
|
0.082 10^9 cells /Liter
Standard Deviation 0.3344
|
0.320 10^9 cells /Liter
Standard Deviation 0.2909
|
-0.244 10^9 cells /Liter
Standard Deviation 0.4865
|
-0.238 10^9 cells /Liter
Standard Deviation 0.2739
|
-0.050 10^9 cells /Liter
Standard Deviation 0.2748
|
0.164 10^9 cells /Liter
Standard Deviation 0.3759
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-0.143 10^9 cells /Liter
Standard Deviation 0.1766
|
-0.093 10^9 cells /Liter
Standard Deviation 0.3449
|
0.285 10^9 cells /Liter
Standard Deviation 0.2741
|
0.142 10^9 cells /Liter
Standard Deviation 0.2643
|
0.207 10^9 cells /Liter
Standard Deviation 0.2388
|
-0.215 10^9 cells /Liter
Standard Deviation 0.3661
|
-0.035 10^9 cells /Liter
Standard Deviation 0.1747
|
0.000 10^9 cells /Liter
Standard Deviation 0.3509
|
0.181 10^9 cells /Liter
Standard Deviation 0.4474
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.097 10^9 cells /Liter
Standard Deviation 0.4866
|
-0.232 10^9 cells /Liter
Standard Deviation 0.3513
|
-0.130 10^9 cells /Liter
Standard Deviation 0.3107
|
-0.027 10^9 cells /Liter
Standard Deviation 0.4607
|
0.082 10^9 cells /Liter
Standard Deviation 0.2491
|
-0.165 10^9 cells /Liter
Standard Deviation 0.6984
|
-0.012 10^9 cells /Liter
Standard Deviation 0.4303
|
-0.067 10^9 cells /Liter
Standard Deviation 0.4020
|
0.005 10^9 cells /Liter
Standard Deviation 0.3483
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, 24 hours, n=6,6,6,6,6,6,5,6,16
|
0.068 10^9 cells /Liter
Standard Deviation 0.2099
|
-0.042 10^9 cells /Liter
Standard Deviation 0.1252
|
0.028 10^9 cells /Liter
Standard Deviation 0.0643
|
0.017 10^9 cells /Liter
Standard Deviation 0.0755
|
0.040 10^9 cells /Liter
Standard Deviation 0.0846
|
-0.107 10^9 cells /Liter
Standard Deviation 0.1405
|
-0.045 10^9 cells /Liter
Standard Deviation 0.0505
|
-0.022 10^9 cells /Liter
Standard Deviation 0.1342
|
-0.014 10^9 cells /Liter
Standard Deviation 0.0870
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, 48 hours, 6,6,5,6,6,6,6,6,16
|
0.083 10^9 cells /Liter
Standard Deviation 0.1533
|
0.083 10^9 cells /Liter
Standard Deviation 0.2224
|
0.037 10^9 cells /Liter
Standard Deviation 0.0441
|
0.048 10^9 cells /Liter
Standard Deviation 0.1052
|
0.043 10^9 cells /Liter
Standard Deviation 0.1198
|
-0.104 10^9 cells /Liter
Standard Deviation 0.1146
|
-0.050 10^9 cells /Liter
Standard Deviation 0.0885
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0854
|
0.002 10^9 cells /Liter
Standard Deviation 0.0795
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.078 10^9 cells /Liter
Standard Deviation 0.1242
|
0.020 10^9 cells /Liter
Standard Deviation 0.1655
|
0.033 10^9 cells /Liter
Standard Deviation 0.0572
|
0.015 10^9 cells /Liter
Standard Deviation 0.1266
|
0.082 10^9 cells /Liter
Standard Deviation 0.1219
|
-0.090 10^9 cells /Liter
Standard Deviation 0.1307
|
-0.047 10^9 cells /Liter
Standard Deviation 0.0579
|
-0.018 10^9 cells /Liter
Standard Deviation 0.1184
|
0.020 10^9 cells /Liter
Standard Deviation 0.0890
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes,FU (Day 15), n= 6,6,6,6,6,6,6,6,16
|
0.115 10^9 cells /Liter
Standard Deviation 0.0789
|
0.008 10^9 cells /Liter
Standard Deviation 0.1439
|
-0.003 10^9 cells /Liter
Standard Deviation 0.0855
|
-0.003 10^9 cells /Liter
Standard Deviation 0.0771
|
0.048 10^9 cells /Liter
Standard Deviation 0.0826
|
-0.022 10^9 cells /Liter
Standard Deviation 0.1309
|
0.020 10^9 cells /Liter
Standard Deviation 0.1619
|
0.045 10^9 cells /Liter
Standard Deviation 0.0896
|
-0.002 10^9 cells /Liter
Standard Deviation 0.0878
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, 24 hours, n=6,6,6,6,6,6,5,6,16
|
-0.500 10^9 cells /Liter
Standard Deviation 2.0326
|
0.110 10^9 cells /Liter
Standard Deviation 0.2985
|
0.035 10^9 cells /Liter
Standard Deviation 0.6405
|
0.528 10^9 cells /Liter
Standard Deviation 0.5383
|
0.583 10^9 cells /Liter
Standard Deviation 0.6552
|
-0.562 10^9 cells /Liter
Standard Deviation 0.7714
|
0.230 10^9 cells /Liter
Standard Deviation 0.8517
|
0.342 10^9 cells /Liter
Standard Deviation 0.4796
|
0.059 10^9 cells /Liter
Standard Deviation 0.7913
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, 48 hours, n=6,6,5,6,6,6,6,6,16
|
-0.455 10^9 cells /Liter
Standard Deviation 1.6850
|
1.425 10^9 cells /Liter
Standard Deviation 2.7042
|
0.153 10^9 cells /Liter
Standard Deviation 0.5704
|
0.507 10^9 cells /Liter
Standard Deviation 0.8878
|
-0.003 10^9 cells /Liter
Standard Deviation 0.5852
|
-0.546 10^9 cells /Liter
Standard Deviation 0.6919
|
-0.007 10^9 cells /Liter
Standard Deviation 0.9485
|
0.342 10^9 cells /Liter
Standard Deviation 0.9186
|
-0.085 10^9 cells /Liter
Standard Deviation 0.7056
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-0.218 10^9 cells /Liter
Standard Deviation 2.3225
|
0.440 10^9 cells /Liter
Standard Deviation 1.1395
|
0.218 10^9 cells /Liter
Standard Deviation 0.4922
|
0.587 10^9 cells /Liter
Standard Deviation 0.7991
|
0.628 10^9 cells /Liter
Standard Deviation 0.6082
|
-0.575 10^9 cells /Liter
Standard Deviation 0.6277
|
-0.027 10^9 cells /Liter
Standard Deviation 0.9432
|
0.513 10^9 cells /Liter
Standard Deviation 0.9082
|
0.055 10^9 cells /Liter
Standard Deviation 0.6401
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, FU (Day 15), n= 6,6,6,6,6,6,6,6,16
|
-0.643 10^9 cells /Liter
Standard Deviation 1.4316
|
0.120 10^9 cells /Liter
Standard Deviation 1.1397
|
0.475 10^9 cells /Liter
Standard Deviation 0.7676
|
0.398 10^9 cells /Liter
Standard Deviation 0.6349
|
0.345 10^9 cells /Liter
Standard Deviation 0.9399
|
0.077 10^9 cells /Liter
Standard Deviation 1.0609
|
-0.037 10^9 cells /Liter
Standard Deviation 0.9710
|
0.302 10^9 cells /Liter
Standard Deviation 0.6797
|
-0.107 10^9 cells /Liter
Standard Deviation 0.7009
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, 24 hours, n=6,6,6,6,6,6,5,6,16
|
7.2 10^9 cells /Liter
Standard Deviation 9.54
|
-9.0 10^9 cells /Liter
Standard Deviation 37.33
|
-1.7 10^9 cells /Liter
Standard Deviation 31.17
|
-0.3 10^9 cells /Liter
Standard Deviation 11.40
|
9.7 10^9 cells /Liter
Standard Deviation 30.29
|
-8.5 10^9 cells /Liter
Standard Deviation 16.11
|
-17.5 10^9 cells /Liter
Standard Deviation 27.90
|
-2.8 10^9 cells /Liter
Standard Deviation 14.48
|
-3.3 10^9 cells /Liter
Standard Deviation 34.99
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, 48 hours, n=6,6,5,6,6,6,6,6,16
|
9.5 10^9 cells /Liter
Standard Deviation 11.64
|
-14.7 10^9 cells /Liter
Standard Deviation 36.62
|
-2.8 10^9 cells /Liter
Standard Deviation 18.97
|
-1.5 10^9 cells /Liter
Standard Deviation 15.95
|
-3.2 10^9 cells /Liter
Standard Deviation 17.33
|
-11.0 10^9 cells /Liter
Standard Deviation 21.13
|
-1.7 10^9 cells /Liter
Standard Deviation 13.08
|
0.7 10^9 cells /Liter
Standard Deviation 14.98
|
0.8 10^9 cells /Liter
Standard Deviation 22.54
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, 96 hours, n=6,6,6,6,6,6,6,6,15
|
6.7 10^9 cells /Liter
Standard Deviation 15.02
|
-13.2 10^9 cells /Liter
Standard Deviation 44.37
|
0.3 10^9 cells /Liter
Standard Deviation 24.34
|
-8.2 10^9 cells /Liter
Standard Deviation 15.75
|
7.3 10^9 cells /Liter
Standard Deviation 14.65
|
-6.8 10^9 cells /Liter
Standard Deviation 14.99
|
1.3 10^9 cells /Liter
Standard Deviation 17.29
|
2.3 10^9 cells /Liter
Standard Deviation 24.57
|
-1.7 10^9 cells /Liter
Standard Deviation 22.98
|
|
Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
13.0 10^9 cells /Liter
Standard Deviation 29.48
|
-13.0 10^9 cells /Liter
Standard Deviation 48.17
|
-4.0 10^9 cells /Liter
Standard Deviation 18.64
|
-10.4 10^9 cells /Liter
Standard Deviation 21.59
|
19.2 10^9 cells /Liter
Standard Deviation 14.66
|
-16.7 10^9 cells /Liter
Standard Deviation 36.59
|
13.0 10^9 cells /Liter
Standard Deviation 15.85
|
6.5 10^9 cells /Liter
Standard Deviation 22.64
|
-1.6 10^9 cells /Liter
Standard Deviation 32.94
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters: erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.
24 hours, n=6,6,6,6,6,6,5,6,16
|
0.198 10^12 cells/Liter
Standard Deviation 0.0933
|
0.084 10^12 cells/Liter
Standard Deviation 0.1928
|
0.302 10^12 cells/Liter
Standard Deviation 0.1447
|
0.118 10^12 cells/Liter
Standard Deviation 0.2576
|
0.338 10^12 cells/Liter
Standard Deviation 0.1150
|
-0.005 10^12 cells/Liter
Standard Deviation 0.1747
|
0.147 10^12 cells/Liter
Standard Deviation 0.2925
|
0.212 10^12 cells/Liter
Standard Deviation 0.2335
|
0.197 10^12 cells/Liter
Standard Deviation 0.2148
|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.
48 hours, n=6,6,5,6,6,6,6,6,16
|
0.288 10^12 cells/Liter
Standard Deviation 0.1082
|
0.087 10^12 cells/Liter
Standard Deviation 0.2295
|
0.180 10^12 cells/Liter
Standard Deviation 0.2440
|
0.162 10^12 cells/Liter
Standard Deviation 0.2899
|
0.142 10^12 cells/Liter
Standard Deviation 0.1607
|
-0.024 10^12 cells/Liter
Standard Deviation 0.2501
|
0.108 10^12 cells/Liter
Standard Deviation 0.3252
|
0.152 10^12 cells/Liter
Standard Deviation 0.1528
|
0.171 10^12 cells/Liter
Standard Deviation 0.2112
|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.
96 hours, n=6,6,6,6,6,6,6,6,15
|
0.112 10^12 cells/Liter
Standard Deviation 0.0674
|
0.062 10^12 cells/Liter
Standard Deviation 0.2528
|
0.237 10^12 cells/Liter
Standard Deviation 0.2530
|
0.155 10^12 cells/Liter
Standard Deviation 0.2290
|
0.202 10^12 cells/Liter
Standard Deviation 0.1683
|
0.083 10^12 cells/Liter
Standard Deviation 0.2499
|
0.178 10^12 cells/Liter
Standard Deviation 0.2320
|
-0.035 10^12 cells/Liter
Standard Deviation 0.2672
|
0.189 10^12 cells/Liter
Standard Deviation 0.1834
|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.
Follow Up (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.053 10^12 cells/Liter
Standard Deviation 0.1549
|
-0.295 10^12 cells/Liter
Standard Deviation 0.2001
|
0.007 10^12 cells/Liter
Standard Deviation 0.2067
|
0.027 10^12 cells/Liter
Standard Deviation 0.1876
|
0.145 10^12 cells/Liter
Standard Deviation 0.2041
|
-0.060 10^12 cells/Liter
Standard Deviation 0.3138
|
0.023 10^12 cells/Liter
Standard Deviation 0.3370
|
-0.205 10^12 cells/Liter
Standard Deviation 0.1639
|
0.032 10^12 cells/Liter
Standard Deviation 0.2691
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters: erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).
24 hour, n=6,6,6,6,6,6,5,6,16
|
-0.28 Femtoliter
Standard Deviation 1.192
|
-0.64 Femtoliter
Standard Deviation 0.754
|
-0.25 Femtoliter
Standard Deviation 0.853
|
-0.50 Femtoliter
Standard Deviation 1.390
|
-0.03 Femtoliter
Standard Deviation 0.497
|
0.17 Femtoliter
Standard Deviation 0.689
|
0.70 Femtoliter
Standard Deviation 0.494
|
-1.07 Femtoliter
Standard Deviation 0.575
|
0.05 Femtoliter
Standard Deviation 0.797
|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).
48 hour, n=6,6,5,6,6,6,6,6,16
|
0.10 Femtoliter
Standard Deviation 1.135
|
-1.18 Femtoliter
Standard Deviation 0.703
|
-0.18 Femtoliter
Standard Deviation 0.725
|
-0.42 Femtoliter
Standard Deviation 0.966
|
0.35 Femtoliter
Standard Deviation 1.231
|
0.06 Femtoliter
Standard Deviation 0.673
|
0.13 Femtoliter
Standard Deviation 0.659
|
-0.57 Femtoliter
Standard Deviation 0.843
|
0.24 Femtoliter
Standard Deviation 0.932
|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).
96 hour,n=6,6,6,6,6,6,6,6,15
|
0.28 Femtoliter
Standard Deviation 1.177
|
-0.15 Femtoliter
Standard Deviation 0.616
|
-0.13 Femtoliter
Standard Deviation 0.388
|
1.75 Femtoliter
Standard Deviation 0.619
|
0.43 Femtoliter
Standard Deviation 0.950
|
0.02 Femtoliter
Standard Deviation 0.979
|
-0.22 Femtoliter
Standard Deviation 1.030
|
-0.85 Femtoliter
Standard Deviation 1.214
|
0.20 Femtoliter
Standard Deviation 1.196
|
|
Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).
Follow up (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.42 Femtoliter
Standard Deviation 1.339
|
-0.10 Femtoliter
Standard Deviation 1.567
|
-0.28 Femtoliter
Standard Deviation 0.840
|
0.15 Femtoliter
Standard Deviation 1.263
|
1.83 Femtoliter
Standard Deviation 0.505
|
0.53 Femtoliter
Standard Deviation 0.850
|
-0.20 Femtoliter
Standard Deviation 1.241
|
-0.15 Femtoliter
Standard Deviation 1.253
|
0.14 Femtoliter
Standard Deviation 1.153
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: Erythrocyte MCH. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
24 hours, n=6,6,6,6,6,6,5,6,16
|
0.15 Picograms
Standard Deviation 0.339
|
0.08 Picograms
Standard Deviation 0.963
|
-0.07 Picograms
Standard Deviation 0.700
|
0.12 Picograms
Standard Deviation 0.337
|
0.18 Picograms
Standard Deviation 0.147
|
0.00 Picograms
Standard Deviation 0.438
|
-0.15 Picograms
Standard Deviation 0.596
|
0.25 Picograms
Standard Deviation 0.485
|
0.01 Picograms
Standard Deviation 0.635
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
48 hours, n=6,6,5,6,6,6,6,6,16
|
-0.18 Picograms
Standard Deviation 0.397
|
-0.03 Picograms
Standard Deviation 0.821
|
0.13 Picograms
Standard Deviation 0.446
|
0.15 Picograms
Standard Deviation 0.464
|
0.08 Picograms
Standard Deviation 0.271
|
0.14 Picograms
Standard Deviation 0.321
|
0.37 Picograms
Standard Deviation 0.779
|
0.73 Picograms
Standard Deviation 0.450
|
0.18 Picograms
Standard Deviation 0.583
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
96 hours,n=6,6,6,6,6,6,6,6,15
|
-0.02 Picograms
Standard Deviation 0.319
|
-0.13 Picograms
Standard Deviation 0.459
|
-0.13 Picograms
Standard Deviation 0.497
|
0.47 Picograms
Standard Deviation 0.339
|
0.02 Picograms
Standard Deviation 0.194
|
-0.33 Picograms
Standard Deviation 0.301
|
0.17 Picograms
Standard Deviation 1.111
|
0.63 Picograms
Standard Deviation 0.589
|
0.17 Picograms
Standard Deviation 0.442
|
|
Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Follow up, Day 15,n=6,6,6,6,6,6,6,6,16
|
-0.40 Picograms
Standard Deviation 0.514
|
-0.03 Picograms
Standard Deviation 0.207
|
0.02 Picograms
Standard Deviation 0.319
|
-0.07 Picograms
Standard Deviation 0.266
|
-0.27 Picograms
Standard Deviation 0.459
|
0.35 Picograms
Standard Deviation 0.660
|
0.03 Picograms
Standard Deviation 0.665
|
0.92 Picograms
Standard Deviation 0.741
|
0.03 Picograms
Standard Deviation 0.639
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
24 hours, n=6,6,6,6,6,6,5,6,16
|
0.0155 Percentage of red blood cells in blood
Standard Deviation 0.01058
|
0.0038 Percentage of red blood cells in blood
Standard Deviation 0.01333
|
0.0250 Percentage of red blood cells in blood
Standard Deviation 0.01416
|
0.0080 Percentage of red blood cells in blood
Standard Deviation 0.02666
|
0.0288 Percentage of red blood cells in blood
Standard Deviation 0.01150
|
0.0003 Percentage of red blood cells in blood
Standard Deviation 0.01791
|
0.0163 Percentage of red blood cells in blood
Standard Deviation 0.02526
|
0.0128 Percentage of red blood cells in blood
Standard Deviation 0.02031
|
0.0174 Percentage of red blood cells in blood
Standard Deviation 0.0174
|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
48 hours, n=6,6,5,6,6,6,6,6,16
|
0.0252 Percentage of red blood cells in blood
Standard Deviation 0.00970
|
0.0013 Percentage of red blood cells in blood
Standard Deviation 0.01739
|
0.0148 Percentage of red blood cells in blood
Standard Deviation 0.02179
|
0.0123 Percentage of red blood cells in blood
Standard Deviation 0.02767
|
0.0143 Percentage of red blood cells in blood
Standard Deviation 0.01521
|
-0.0018 Percentage of red blood cells in blood
Standard Deviation 0.02255
|
0.0102 Percentage of red blood cells in blood
Standard Deviation 0.02851
|
0.0103 Percentage of red blood cells in blood
Standard Deviation 0.01256
|
0.0163 Percentage of red blood cells in blood
Standard Deviation 0.0163
|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
96 hours,n=6,6,6,6,6,6,6,6,15
|
0.0108 Percentage of red blood cells in blood
Standard Deviation 0.00947
|
0.0045 Percentage of red blood cells in blood
Standard Deviation 0.02345
|
0.0200 Percentage of red blood cells in blood
Standard Deviation 0.02265
|
0.0223 Percentage of red blood cells in blood
Standard Deviation 0.01896
|
0.0198 Percentage of red blood cells in blood
Standard Deviation 0.01771
|
0.0078 Percentage of red blood cells in blood
Standard Deviation 0.02337
|
0.0145 Percentage of red blood cells in blood
Standard Deviation 0.02346
|
-0.0072 Percentage of red blood cells in blood
Standard Deviation 0.02753
|
0.0177 Percentage of red blood cells in blood
Standard Deviation 0.0177
|
|
Part 1: Change From Baseline in Hematology Parameter: Hematocrit
Follow up (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.0070 Percentage of red blood cells in blood
Standard Deviation 0.01534
|
-0.0265 Percentage of red blood cells in blood
Standard Deviation 0.01852
|
-0.0007 Percentage of red blood cells in blood
Standard Deviation 0.01945
|
0.0032 Percentage of red blood cells in blood
Standard Deviation 0.02247
|
0.0222 Percentage of red blood cells in blood
Standard Deviation 0.01879
|
-0.0025 Percentage of red blood cells in blood
Standard Deviation 0.02848
|
0.0012 Percentage of red blood cells in blood
Standard Deviation 0.03201
|
-0.0185 Percentage of red blood cells in blood
Standard Deviation 0.01816
|
0.0035 Percentage of red blood cells in blood
Standard Deviation 0.02603
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
24 hours, n=6,6,6,6,6,6,5,6,16
|
-0.00015 10^12 cells per liter
Standard Deviation 0.001276
|
0.00156 10^12 cells per liter
Standard Deviation 0.002490
|
0.00057 10^12 cells per liter
Standard Deviation 0.000579
|
0.00050 10^12 cells per liter
Standard Deviation 0.001390
|
0.00055 10^12 cells per liter
Standard Deviation 0.001608
|
0.00118 10^12 cells per liter
Standard Deviation 0.001955
|
-0.00023 10^12 cells per liter
Standard Deviation 0.002223
|
0.00022 10^12 cells per liter
Standard Deviation 0.001694
|
0.00071 10^12 cells per liter
Standard Deviation 0.001808
|
|
Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
48 hours, n=6,6,5,6,6,6,6,6,16
|
0.00075 10^12 cells per liter
Standard Deviation 0.001838
|
0.00260 10^12 cells per liter
Standard Deviation 0.002924
|
0.00117 10^12 cells per liter
Standard Deviation 0.001859
|
0.00082 10^12 cells per liter
Standard Deviation 0.001496
|
0.00123 10^12 cells per liter
Standard Deviation 0.001334
|
0.00154 10^12 cells per liter
Standard Deviation 0.001790
|
-0.00017 10^12 cells per liter
Standard Deviation 0.002028
|
0.00070 10^12 cells per liter
Standard Deviation 0.001451
|
0.00118 10^12 cells per liter
Standard Deviation 0.002221
|
|
Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
96 hours,n=6,6,6,6,6,6,6,6,15
|
0.00060 10^12 cells per liter
Standard Deviation 0.001663
|
0.00265 10^12 cells per liter
Standard Deviation 0.002867
|
0.00175 10^12 cells per liter
Standard Deviation 0.002019
|
-0.00005 10^12 cells per liter
Standard Deviation 0.002040
|
0.00160 10^12 cells per liter
Standard Deviation 0.001615
|
0.00095 10^12 cells per liter
Standard Deviation 0.002517
|
0.00023 10^12 cells per liter
Standard Deviation 0.001965
|
0.00138 10^12 cells per liter
Standard Deviation 0.001841
|
0.00162 10^12 cells per liter
Standard Deviation 0.002889
|
|
Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Follow up (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.00015 10^12 cells per liter
Standard Deviation 0.001640
|
-0.00002 10^12 cells per liter
Standard Deviation 0.001841
|
0.00055 10^12 cells per liter
Standard Deviation 0.002230
|
-0.00018 10^12 cells per liter
Standard Deviation 0.001273
|
0.00435 10^12 cells per liter
Standard Deviation 0.001628
|
-0.00077 10^12 cells per liter
Standard Deviation 0.002293
|
-0.00042 10^12 cells per liter
Standard Deviation 0.002832
|
0.00092 10^12 cells per liter
Standard Deviation 0.002495
|
0.00061 10^12 cells per liter
Standard Deviation 0.003329
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
48 hours, n=6,6,5,6,6,6,6,6,16
|
7.7 Grams per liter
Standard Deviation 3.72
|
2.5 Grams per liter
Standard Deviation 6.35
|
6.2 Grams per liter
Standard Deviation 7.88
|
5.7 Grams per liter
Standard Deviation 10.65
|
4.7 Grams per liter
Standard Deviation 5.89
|
0.0 Grams per liter
Standard Deviation 6.60
|
5.2 Grams per liter
Standard Deviation 6.88
|
8.3 Grams per liter
Standard Deviation 3.20
|
6.0 Grams per liter
Standard Deviation 7.85
|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
24 hours, n=6,6,6,6,6,6,5,6,16
|
6.8 Grams per liter
Standard Deviation 1.72
|
3.0 Grams per liter
Standard Deviation 6.04
|
8.8 Grams per liter
Standard Deviation 7.91
|
4.2 Grams per liter
Standard Deviation 8.93
|
10.8 Grams per liter
Standard Deviation 3.43
|
0.0 Grams per liter
Standard Deviation 5.51
|
3.5 Grams per liter
Standard Deviation 7.34
|
7.7 Grams per liter
Standard Deviation 5.82
|
5.9 Grams per liter
Standard Deviation 7.29
|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
96 hours, n=6,6,6,6,6,6,6,6,15
|
3.2 Grams per liter
Standard Deviation 2.71
|
1.2 Grams per liter
Standard Deviation 9.13
|
6.5 Grams per liter
Standard Deviation 9.67
|
6.8 Grams per liter
Standard Deviation 6.27
|
6.0 Grams per liter
Standard Deviation 5.33
|
0.8 Grams per liter
Standard Deviation 6.49
|
6.3 Grams per liter
Standard Deviation 7.00
|
2.3 Grams per liter
Standard Deviation 7.97
|
6.6 Grams per liter
Standard Deviation 5.51
|
|
Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)
Follow up (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.5 Grams per liter
Standard Deviation 3.39
|
-9.2 Grams per liter
Standard Deviation 6.82
|
0.2 Grams per liter
Standard Deviation 6.37
|
0.5 Grams per liter
Standard Deviation 5.75
|
3.0 Grams per liter
Standard Deviation 7.24
|
0.0 Grams per liter
Standard Deviation 11.05
|
1.0 Grams per liter
Standard Deviation 7.97
|
-1.5 Grams per liter
Standard Deviation 7.06
|
1.0 Grams per liter
Standard Deviation 8.25
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameter: ALT, AST, and ALP. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALT, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-3.8 International units per liter
Standard Deviation 3.49
|
0.0 International units per liter
Standard Deviation 5.44
|
-0.3 International units per liter
Standard Deviation 5.05
|
-1.7 International units per liter
Standard Deviation 4.55
|
0.3 International units per liter
Standard Deviation 3.39
|
0.8 International units per liter
Standard Deviation 3.60
|
-3.8 International units per liter
Standard Deviation 2.04
|
-0.5 International units per liter
Standard Deviation 4.93
|
-0.8 International units per liter
Standard Deviation 4.68
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALT, 48 hours, n=6,6,6,6,6,6,6,5,16
|
-2.7 International units per liter
Standard Deviation 6.25
|
-2.7 International units per liter
Standard Deviation 4.89
|
5.0 International units per liter
Standard Deviation 10.17
|
-1.5 International units per liter
Standard Deviation 5.75
|
-0.2 International units per liter
Standard Deviation 4.49
|
0.3 International units per liter
Standard Deviation 4.37
|
1.2 International units per liter
Standard Deviation 2.23
|
0.5 International units per liter
Standard Deviation 4.04
|
-0.1 International units per liter
Standard Deviation 4.94
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALT, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-3.5 International units per liter
Standard Deviation 8.26
|
0.5 International units per liter
Standard Deviation 4.85
|
3.8 International units per liter
Standard Deviation 10.76
|
-0.5 International units per liter
Standard Deviation 5.01
|
4.0 International units per liter
Standard Deviation 3.90
|
1.3 International units per liter
Standard Deviation 4.68
|
2.2 International units per liter
Standard Deviation 3.19
|
2.5 International units per liter
Standard Deviation 5.47
|
2.5 International units per liter
Standard Deviation 8.08
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALT, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.3 International units per liter
Standard Deviation 14.35
|
1.0 International units per liter
Standard Deviation 4.34
|
5.3 International units per liter
Standard Deviation 6.06
|
-0.3 International units per liter
Standard Deviation 10.01
|
2.3 International units per liter
Standard Deviation 4.32
|
2.3 International units per liter
Standard Deviation 3.56
|
9.5 International units per liter
Standard Deviation 14.46
|
5.2 International units per liter
Standard Deviation 9.95
|
5.1 International units per liter
Standard Deviation 15.95
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
AST, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-4.7 International units per liter
Standard Deviation 6.74
|
-0.7 International units per liter
Standard Deviation 3.72
|
-1.3 International units per liter
Standard Deviation 2.94
|
-5.7 International units per liter
Standard Deviation 7.63
|
-0.4 International units per liter
Standard Deviation 3.13
|
-2.5 International units per liter
Standard Deviation 2.88
|
-4.2 International units per liter
Standard Deviation 1.94
|
-3.5 International units per liter
Standard Deviation 4.72
|
-3.0 International units per liter
Standard Deviation 3.60
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
AST, 48 hours, n=6,6,6,6,6,6,6,5,16
|
-2.5 International units per liter
Standard Deviation 3.33
|
-2.0 International units per liter
Standard Deviation 3.85
|
1.4 International units per liter
Standard Deviation 5.86
|
-4.3 International units per liter
Standard Deviation 7.50
|
-2.3 International units per liter
Standard Deviation 3.83
|
-3.0 International units per liter
Standard Deviation 2.10
|
-2.2 International units per liter
Standard Deviation 1.72
|
-0.7 International units per liter
Standard Deviation 4.80
|
-2.6 International units per liter
Standard Deviation 4.11
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
AST, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-4.5 International units per liter
Standard Deviation 4.85
|
-1.8 International units per liter
Standard Deviation 4.31
|
-1.5 International units per liter
Standard Deviation 4.89
|
-4.2 International units per liter
Standard Deviation 8.57
|
-1.7 International units per liter
Standard Deviation 3.20
|
-4.2 International units per liter
Standard Deviation 3.97
|
-1.3 International units per liter
Standard Deviation 2.73
|
-3.3 International units per liter
Standard Deviation 4.89
|
-1.4 International units per liter
Standard Deviation 3.48
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
AST, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-1.7 International units per liter
Standard Deviation 2.80
|
2.2 International units per liter
Standard Deviation 8.26
|
0.9 International units per liter
Standard Deviation 5.87
|
-1.5 International units per liter
Standard Deviation 8.53
|
4.5 International units per liter
Standard Deviation 9.57
|
1.0 International units per liter
Standard Deviation 5.18
|
-0.5 International units per liter
Standard Deviation 2.88
|
4.5 International units per liter
Standard Deviation 5.36
|
0.9 International units per liter
Standard Deviation 5.87
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALP, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-1.2 International units per liter
Standard Deviation 8.42
|
-0.2 International units per liter
Standard Deviation 4.67
|
0.7 International units per liter
Standard Deviation 3.78
|
2.8 International units per liter
Standard Deviation 4.54
|
6.0 International units per liter
Standard Deviation 3.74
|
1.2 International units per liter
Standard Deviation 8.28
|
-1.0 International units per liter
Standard Deviation 6.66
|
-2.8 International units per liter
Standard Deviation 6.15
|
-2.9 International units per liter
Standard Deviation 4.10
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALP, 48 hours, n=6,6,6,6,6,6,6,5,16
|
-1.5 International units per liter
Standard Deviation 8.29
|
-0.8 International units per liter
Standard Deviation 5.31
|
0.6 International units per liter
Standard Deviation 2.97
|
3.3 International units per liter
Standard Deviation 4.93
|
1.7 International units per liter
Standard Deviation 5.13
|
2.2 International units per liter
Standard Deviation 6.24
|
-0.8 International units per liter
Standard Deviation 5.31
|
-1.7 International units per liter
Standard Deviation 6.65
|
-2.4 International units per liter
Standard Deviation 4.84
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALP, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-4.8 International units per liter
Standard Deviation 9.11
|
1.5 International units per liter
Standard Deviation 6.19
|
1.2 International units per liter
Standard Deviation 3.49
|
3.3 International units per liter
Standard Deviation 4.18
|
5.2 International units per liter
Standard Deviation 2.93
|
3.5 International units per liter
Standard Deviation 10.09
|
0.0 International units per liter
Standard Deviation 5.18
|
0.5 International units per liter
Standard Deviation 4.85
|
-1.1 International units per liter
Standard Deviation 4.16
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)
ALP, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-1.8 International units per liter
Standard Deviation 6.01
|
-0.8 International units per liter
Standard Deviation 5.98
|
-0.3 International units per liter
Standard Deviation 1.97
|
0.3 International units per liter
Standard Deviation 1.37
|
1.5 International units per liter
Standard Deviation 3.27
|
-0.5 International units per liter
Standard Deviation 4.81
|
2.2 International units per liter
Standard Deviation 6.62
|
-1.2 International units per liter
Standard Deviation 6.97
|
-0.4 International units per liter
Standard Deviation 6.37
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0.5 Millimoles per liter
Standard Deviation 1.76
|
-2.2 Millimoles per liter
Standard Deviation 1.47
|
0.0 Millimoles per liter
Standard Deviation 1.67
|
0.7 Millimoles per liter
Standard Deviation 1.86
|
3.0 Millimoles per liter
Standard Deviation 3.03
|
-3.2 Millimoles per liter
Standard Deviation 3.06
|
2.2 Millimoles per liter
Standard Deviation 2.04
|
-0.2 Millimoles per liter
Standard Deviation 2.14
|
0.8 Millimoles per liter
Standard Deviation 2.59
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, 48 hours, n=6,6,6,6,6,6,6,5,16
|
5.8 Millimoles per liter
Standard Deviation 3.71
|
-0.5 Millimoles per liter
Standard Deviation 1.38
|
-1.8 Millimoles per liter
Standard Deviation 1.64
|
0.3 Millimoles per liter
Standard Deviation 1.86
|
3.5 Millimoles per liter
Standard Deviation 2.66
|
-1.3 Millimoles per liter
Standard Deviation 2.42
|
2.7 Millimoles per liter
Standard Deviation 1.86
|
2.2 Millimoles per liter
Standard Deviation 1.94
|
2.1 Millimoles per liter
Standard Deviation 3.57
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.8 Millimoles per liter
Standard Deviation 1.94
|
-2.2 Millimoles per liter
Standard Deviation 2.04
|
-2.2 Millimoles per liter
Standard Deviation 2.32
|
-1.2 Millimoles per liter
Standard Deviation 1.72
|
2.0 Millimoles per liter
Standard Deviation 3.41
|
-2.0 Millimoles per liter
Standard Deviation 2.76
|
1.3 Millimoles per liter
Standard Deviation 2.50
|
-1.2 Millimoles per liter
Standard Deviation 4.31
|
1.1 Millimoles per liter
Standard Deviation 2.47
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate,FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
1.2 Millimoles per liter
Standard Deviation 2.93
|
-0.3 Millimoles per liter
Standard Deviation 2.88
|
-0.8 Millimoles per liter
Standard Deviation 1.47
|
0.2 Millimoles per liter
Standard Deviation 1.47
|
1.5 Millimoles per liter
Standard Deviation 1.05
|
-1.8 Millimoles per liter
Standard Deviation 2.64
|
1.7 Millimoles per liter
Standard Deviation 1.75
|
1.2 Millimoles per liter
Standard Deviation 1.94
|
1.1 Millimoles per liter
Standard Deviation 1.65
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0.060 Millimoles per liter
Standard Deviation 0.0562
|
0.035 Millimoles per liter
Standard Deviation 0.0731
|
0.002 Millimoles per liter
Standard Deviation 0.0454
|
-0.045 Millimoles per liter
Standard Deviation 0.0931
|
0.038 Millimoles per liter
Standard Deviation 0.0627
|
-0.037 Millimoles per liter
Standard Deviation 0.0866
|
-0.033 Millimoles per liter
Standard Deviation 0.0987
|
-0.012 Millimoles per liter
Standard Deviation 0.0492
|
0.005 Millimoles per liter
Standard Deviation 0.0647
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, 48 hours, n=6,6,6,6,6,6,6,5,16
|
0.145 Millimoles per liter
Standard Deviation 0.0568
|
-0.017 Millimoles per liter
Standard Deviation 0.0476
|
-0.018 Millimoles per liter
Standard Deviation 0.0349
|
0.047 Millimoles per liter
Standard Deviation 0.0997
|
0.042 Millimoles per liter
Standard Deviation 0.0581
|
-0.032 Millimoles per liter
Standard Deviation 0.0731
|
-0.008 Millimoles per liter
Standard Deviation 0.0808
|
0.008 Millimoles per liter
Standard Deviation 0.0736
|
0.031 Millimoles per liter
Standard Deviation 0.0762
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.097 Millimoles per liter
Standard Deviation 0.0625
|
0.025 Millimoles per liter
Standard Deviation 0.0497
|
-0.045 Millimoles per liter
Standard Deviation 0.0836
|
-0.005 Millimoles per liter
Standard Deviation 0.0909
|
0.070 Millimoles per liter
Standard Deviation 0.0687
|
-0.012 Millimoles per liter
Standard Deviation 0.0838
|
0.027 Millimoles per liter
Standard Deviation 0.0747
|
-0.015 Millimoles per liter
Standard Deviation 0.0680
|
0.034 Millimoles per liter
Standard Deviation 0.0687
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.043 Millimoles per liter
Standard Deviation 0.0753
|
-0.017 Millimoles per liter
Standard Deviation 0.1134
|
-0.027 Millimoles per liter
Standard Deviation 0.0455
|
0.003 Millimoles per liter
Standard Deviation 0.0686
|
0.060 Millimoles per liter
Standard Deviation 0.0620
|
0.008 Millimoles per liter
Standard Deviation 0.1194
|
0.003 Millimoles per liter
Standard Deviation 0.0709
|
-0.047 Millimoles per liter
Standard Deviation 0.0528
|
0.033 Millimoles per liter
Standard Deviation 0.0694
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0.5 Millimoles per liter
Standard Deviation 2.66
|
-0.7 Millimoles per liter
Standard Deviation 2.16
|
0.3 Millimoles per liter
Standard Deviation 2.73
|
1.8 Millimoles per liter
Standard Deviation 1.47
|
-2.2 Millimoles per liter
Standard Deviation 2.04
|
2.7 Millimoles per liter
Standard Deviation 2.07
|
-0.5 Millimoles per liter
Standard Deviation 1.87
|
0.2 Millimoles per liter
Standard Deviation 3.06
|
0.6 Millimoles per liter
Standard Deviation 2.00
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, 48 hours, n=6,6,6,6,6,6,6,5,16
|
0.7 Millimoles per liter
Standard Deviation 3.08
|
-0.7 Millimoles per liter
Standard Deviation 2.73
|
0.6 Millimoles per liter
Standard Deviation 1.95
|
1.8 Millimoles per liter
Standard Deviation 1.47
|
-0.8 Millimoles per liter
Standard Deviation 1.47
|
2.3 Millimoles per liter
Standard Deviation 1.63
|
-2.0 Millimoles per liter
Standard Deviation 1.90
|
-0.2 Millimoles per liter
Standard Deviation 2.32
|
0.5 Millimoles per liter
Standard Deviation 1.75
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.3 Millimoles per liter
Standard Deviation 2.94
|
0.7 Millimoles per liter
Standard Deviation 2.16
|
-1.3 Millimoles per liter
Standard Deviation 1.97
|
1.7 Millimoles per liter
Standard Deviation 1.21
|
-1.2 Millimoles per liter
Standard Deviation 2.99
|
1.0 Millimoles per liter
Standard Deviation 2.00
|
0.0 Millimoles per liter
Standard Deviation 1.79
|
-0.5 Millimoles per liter
Standard Deviation 2.88
|
0.1 Millimoles per liter
Standard Deviation 2.76
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.8 Millimoles per liter
Standard Deviation 2.48
|
0.8 Millimoles per liter
Standard Deviation 2.48
|
-0.7 Millimoles per liter
Standard Deviation 3.27
|
0.7 Millimoles per liter
Standard Deviation 1.37
|
-0.3 Millimoles per liter
Standard Deviation 2.25
|
0.5 Millimoles per liter
Standard Deviation 1.64
|
-0.3 Millimoles per liter
Standard Deviation 2.07
|
1.3 Millimoles per liter
Standard Deviation 3.39
|
-0.6 Millimoles per liter
Standard Deviation 1.75
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0.033 Millimoles per liter
Standard Deviation 0.0398
|
0.003 Millimoles per liter
Standard Deviation 0.0339
|
0.012 Millimoles per liter
Standard Deviation 0.0560
|
-0.018 Millimoles per liter
Standard Deviation 0.0483
|
-0.017 Millimoles per liter
Standard Deviation 0.0350
|
0.023 Millimoles per liter
Standard Deviation 0.0393
|
0.023 Millimoles per liter
Standard Deviation 0.0398
|
0.003 Millimoles per liter
Standard Deviation 0.0393
|
0.014 Millimoles per liter
Standard Deviation 0.0495
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, 48 hours, n=6,6,6,6,6,6,6,5,16
|
0.060 Millimoles per liter
Standard Deviation 0.0369
|
0.025 Millimoles per liter
Standard Deviation 0.0459
|
0.034 Millimoles per liter
Standard Deviation 0.0513
|
0.043 Millimoles per liter
Standard Deviation 0.0983
|
0.005 Millimoles per liter
Standard Deviation 0.0513
|
0.035 Millimoles per liter
Standard Deviation 0.0468
|
0.012 Millimoles per liter
Standard Deviation 0.0349
|
0.017 Millimoles per liter
Standard Deviation 0.0476
|
0.034 Millimoles per liter
Standard Deviation 0.0626
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.048 Millimoles per liter
Standard Deviation 0.0204
|
0.033 Millimoles per liter
Standard Deviation 0.0308
|
0.007 Millimoles per liter
Standard Deviation 0.0476
|
0.010 Millimoles per liter
Standard Deviation 0.0525
|
0.022 Millimoles per liter
Standard Deviation 0.0488
|
0.037 Millimoles per liter
Standard Deviation 0.0535
|
0.015 Millimoles per liter
Standard Deviation 0.0568
|
0.002 Millimoles per liter
Standard Deviation 0.0264
|
0.042 Millimoles per liter
Standard Deviation 0.0507
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.017 Millimoles per liter
Standard Deviation 0.0367
|
0.013 Millimoles per liter
Standard Deviation 0.0550
|
-0.015 Millimoles per liter
Standard Deviation 0.0468
|
0.008 Millimoles per liter
Standard Deviation 0.0643
|
-0.035 Millimoles per liter
Standard Deviation 0.0367
|
-0.020 Millimoles per liter
Standard Deviation 0.0583
|
0.010 Millimoles per liter
Standard Deviation 0.0502
|
-0.017 Millimoles per liter
Standard Deviation 0.0361
|
0.002 Millimoles per liter
Standard Deviation 0.0489
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-0.010 Millimoles per liter
Standard Deviation 0.1803
|
0.032 Millimoles per liter
Standard Deviation 0.1647
|
-0.018 Millimoles per liter
Standard Deviation 0.0968
|
0.088 Millimoles per liter
Standard Deviation 0.1074
|
0.117 Millimoles per liter
Standard Deviation 0.1777
|
0.098 Millimoles per liter
Standard Deviation 0.1843
|
-0.080 Millimoles per liter
Standard Deviation 0.1370
|
-0.003 Millimoles per liter
Standard Deviation 0.1279
|
0.020 Millimoles per liter
Standard Deviation 0.1363
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, 48 hours, n=6,6,6,6,6,6,6,5,16
|
-0.058 Millimoles per liter
Standard Deviation 0.1816
|
0.025 Millimoles per liter
Standard Deviation 0.1801
|
-0.076 Millimoles per liter
Standard Deviation 0.0963
|
0.148 Millimoles per liter
Standard Deviation 0.0679
|
-0.022 Millimoles per liter
Standard Deviation 0.1713
|
0.107 Millimoles per liter
Standard Deviation 0.1540
|
-0.063 Millimoles per liter
Standard Deviation 0.1528
|
-0.043 Millimoles per liter
Standard Deviation 0.1499
|
0.022 Millimoles per liter
Standard Deviation 0.1561
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-0.027 Millimoles per liter
Standard Deviation 0.1645
|
0.092 Millimoles per liter
Standard Deviation 0.1240
|
0.042 Millimoles per liter
Standard Deviation 0.1144
|
0.077 Millimoles per liter
Standard Deviation 0.1084
|
0.122 Millimoles per liter
Standard Deviation 0.1854
|
0.098 Millimoles per liter
Standard Deviation 0.1485
|
-0.055 Millimoles per liter
Standard Deviation 0.1934
|
-0.028 Millimoles per liter
Standard Deviation 0.0995
|
0.029 Millimoles per liter
Standard Deviation 0.1391
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.055 Millimoles per liter
Standard Deviation 0.1407
|
0.063 Millimoles per liter
Standard Deviation 0.1138
|
0.002 Millimoles per liter
Standard Deviation 0.1341
|
0.107 Millimoles per liter
Standard Deviation 0.1224
|
-0.018 Millimoles per liter
Standard Deviation 0.1230
|
0.1230 Millimoles per liter
Standard Deviation 0.1378
|
-0.090 Millimoles per liter
Standard Deviation 0.1485
|
0.042 Millimoles per liter
Standard Deviation 0.1865
|
-0.022 Millimoles per liter
Standard Deviation 0.1285
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0.22 Millimoles per liter
Standard Deviation 0.313
|
0.10 Millimoles per liter
Standard Deviation 0.245
|
-0.05 Millimoles per liter
Standard Deviation 0.423
|
0.03 Millimoles per liter
Standard Deviation 0.647
|
0.42 Millimoles per liter
Standard Deviation 0.313
|
0.33 Millimoles per liter
Standard Deviation 0.327
|
0.20 Millimoles per liter
Standard Deviation 0.290
|
0.20 Millimoles per liter
Standard Deviation 0.276
|
0.25 Millimoles per liter
Standard Deviation 0.316
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, 48 hours, n=6,6,6,6,6,6,6,5,16
|
0.30 Millimoles per liter
Standard Deviation 0.228
|
0.07 Millimoles per liter
Standard Deviation 0.163
|
0.06 Millimoles per liter
Standard Deviation 0.251
|
0.28 Millimoles per liter
Standard Deviation 0.417
|
0.30 Millimoles per liter
Standard Deviation 0.310
|
0.25 Millimoles per liter
Standard Deviation 0.217
|
0.07 Millimoles per liter
Standard Deviation 0.258
|
0.20 Millimoles per liter
Standard Deviation 0.253
|
0.16 Millimoles per liter
Standard Deviation 0.278
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.20 Millimoles per liter
Standard Deviation 0.316
|
0.08 Millimoles per liter
Standard Deviation 0.232
|
-0.12 Millimoles per liter
Standard Deviation 0.204
|
0.00 Millimoles per liter
Standard Deviation 0.525
|
0.30 Millimoles per liter
Standard Deviation 0.335
|
0.38 Millimoles per liter
Standard Deviation 0.306
|
0.12 Millimoles per liter
Standard Deviation 0.232
|
0.20 Millimoles per liter
Standard Deviation 0.352
|
0.30 Millimoles per liter
Standard Deviation 0.314
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.18 Millimoles per liter
Standard Deviation 0.183
|
0.05 Millimoles per liter
Standard Deviation 0.339
|
-0.27 Millimoles per liter
Standard Deviation 0.314
|
0.12 Millimoles per liter
Standard Deviation 0.436
|
0.43 Millimoles per liter
Standard Deviation 0.413
|
-0.05 Millimoles per liter
Standard Deviation 0.207
|
-0.03 Millimoles per liter
Standard Deviation 0.356
|
0.07 Millimoles per liter
Standard Deviation 0.250
|
0.10 Millimoles per liter
Standard Deviation 0.379
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-0.3 Millimoles per liter
Standard Deviation 2.42
|
-1.3 Millimoles per liter
Standard Deviation 1.21
|
0.5 Millimoles per liter
Standard Deviation 2.26
|
0.0 Millimoles per liter
Standard Deviation 1.26
|
0.0 Millimoles per liter
Standard Deviation 1.90
|
0.3 Millimoles per liter
Standard Deviation 2.16
|
-0.7 Millimoles per liter
Standard Deviation 1.63
|
-1.5 Millimoles per liter
Standard Deviation 0.55
|
0.3 Millimoles per liter
Standard Deviation 1.95
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, 48 hours, n=6,6,6,6,6,6,6,5,16
|
1.2 Millimoles per liter
Standard Deviation 2.23
|
-1.3 Millimoles per liter
Standard Deviation 2.25
|
0.8 Millimoles per liter
Standard Deviation 1.92
|
1.0 Millimoles per liter
Standard Deviation 1.10
|
-0.2 Millimoles per liter
Standard Deviation 2.14
|
1.0 Millimoles per liter
Standard Deviation 1.67
|
-0.7 Millimoles per liter
Standard Deviation 1.37
|
-1.8 Millimoles per liter
Standard Deviation 1.60
|
0.8 Millimoles per liter
Standard Deviation 1.80
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.0 Millimoles per liter
Standard Deviation 0.20
|
0.8 Millimoles per liter
Standard Deviation 1.83
|
1.3 Millimoles per liter
Standard Deviation 1.03
|
0.8 Millimoles per liter
Standard Deviation 1.47
|
0.5 Millimoles per liter
Standard Deviation 1.64
|
0.7 Millimoles per liter
Standard Deviation 1.21
|
1.3 Millimoles per liter
Standard Deviation 3.01
|
-1.7 Millimoles per liter
Standard Deviation 1.86
|
0.5 Millimoles per liter
Standard Deviation 2.42
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.7 Millimoles per liter
Standard Deviation 2.07
|
0.5 Millimoles per liter
Standard Deviation 2.17
|
0.0 Millimoles per liter
Standard Deviation 2.19
|
0.8 Millimoles per liter
Standard Deviation 2.14
|
0.3 Millimoles per liter
Standard Deviation 2.07
|
-0.2 Millimoles per liter
Standard Deviation 1.47
|
-0.2 Millimoles per liter
Standard Deviation 1.47
|
0.8 Millimoles per liter
Standard Deviation 1.72
|
0.4 Millimoles per liter
Standard Deviation 1.82
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-0.599760 Millimoles per liter
Standard Deviation 0.7717016
|
0.133280 Millimoles per liter
Standard Deviation 0.3880028
|
-0.849660 Millimoles per liter
Standard Deviation 1.3570283
|
0.033320 Millimoles per liter
Standard Deviation 0.3443425
|
0.283220 Millimoles per liter
Standard Deviation 1.0396160
|
0.299880 Millimoles per liter
Standard Deviation 0.6630596
|
-0.649740 Millimoles per liter
Standard Deviation 1.0517198
|
-0.166600 Millimoles per liter
Standard Deviation 0.8450414
|
-0.187425 Millimoles per liter
Standard Deviation 0.9102217
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, 48 hours, n=6,6,6,6,6,6,6,5,16
|
-0.316540 Millimoles per liter
Standard Deviation 0.6366649
|
0.083300 Millimoles per liter
Standard Deviation 0.7108180
|
-1.099560 Millimoles per liter
Standard Deviation 0.8242913
|
-0.316540 Millimoles per liter
Standard Deviation 0.8081731
|
0.416500 Millimoles per liter
Standard Deviation 0.8769556
|
0.116620 Millimoles per liter
Standard Deviation 0.7701895
|
-0.683060 Millimoles per liter
Standard Deviation 1.0103710
|
-0.233240 Millimoles per liter
Standard Deviation 0.9601712
|
-0.187425 Millimoles per liter
Standard Deviation 1.0590572
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, 96 hours, n=6,6,6,6,6,6,6,6,15
|
0.049980 Millimoles per liter
Standard Deviation 0.5955804
|
0.166600 Millimoles per liter
Standard Deviation 0.9241120
|
-0.916300 Millimoles per liter
Standard Deviation 1.5178348
|
-0.116620 Millimoles per liter
Standard Deviation 0.7274909
|
0.233240 Millimoles per liter
Standard Deviation 0.9476011
|
0.316540 Millimoles per liter
Standard Deviation 1.0510863
|
-0.733040 Millimoles per liter
Standard Deviation 1.1736967
|
-0.433160 Millimoles per liter
Standard Deviation 0.5986483
|
0.046648 Millimoles per liter
Standard Deviation 1.2598057
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea,FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.649740 Millimoles per liter
Standard Deviation 0.7173480
|
-0.033320 Millimoles per liter
Standard Deviation 1.0907403
|
-1.332800 Millimoles per liter
Standard Deviation 1.4230410
|
-0.483140 Millimoles per liter
Standard Deviation 0.9491815
|
0.466480 Millimoles per liter
Standard Deviation 0.9929136
|
0.466480 Millimoles per liter
Standard Deviation 0.3828177
|
-0.499800 Millimoles per liter
Standard Deviation 0.5930586
|
-0.233240 Millimoles per liter
Standard Deviation 2.0187631
|
-0.099960 Millimoles per liter
Standard Deviation 0.6590288
|
PRIMARY outcome
Timeframe: Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameter: cholesterol, glucose, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
Triglycerides,Day1,96 hours,n=5,6,6,6,5,6,6,6,14
|
0.60 Millimoles per liter
Standard Deviation 0.883
|
0.03 Millimoles per liter
Standard Deviation 0.468
|
0.70 Millimoles per liter
Standard Deviation 0.834
|
0.28 Millimoles per liter
Standard Deviation 0.531
|
0.60 Millimoles per liter
Standard Deviation 1.079
|
0.45 Millimoles per liter
Standard Deviation 0.468
|
0.62 Millimoles per liter
Standard Deviation 1.026
|
0.52 Millimoles per liter
Standard Deviation 0.931
|
0.49 Millimoles per liter
Standard Deviation 0.360
|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
Cholesterol,Day1,96 hours,n=5,6,6,6,5,6,6,6,14
|
0.13 Millimoles per liter
Standard Deviation 0.516
|
0.45 Millimoles per liter
Standard Deviation 0.373
|
0.43 Millimoles per liter
Standard Deviation 0.641
|
0.40 Millimoles per liter
Standard Deviation 0.324
|
0.32 Millimoles per liter
Standard Deviation 0.271
|
-0.05 Millimoles per liter
Standard Deviation 0.628
|
0.02 Millimoles per liter
Standard Deviation 0.422
|
-0.06 Millimoles per liter
Standard Deviation 0.699
|
0.30 Millimoles per liter
Standard Deviation 0.445
|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
Cholesterol, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.40 Millimoles per liter
Standard Deviation 0.562
|
0.08 Millimoles per liter
Standard Deviation 0.445
|
0.22 Millimoles per liter
Standard Deviation 0.496
|
0.25 Millimoles per liter
Standard Deviation 0.404
|
0.23 Millimoles per liter
Standard Deviation 0.327
|
0.07 Millimoles per liter
Standard Deviation 0.579
|
0.23 Millimoles per liter
Standard Deviation 0.493
|
-0.16 Millimoles per liter
Standard Deviation 0.590
|
0.16 Millimoles per liter
Standard Deviation 0.566
|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
HDL cholesterol,Day1,96 hours,n=6,6,6,6,5,6,6,6,15
|
-0.12 Millimoles per liter
Standard Deviation 0.098
|
-0.02 Millimoles per liter
Standard Deviation 0.133
|
-0.13 Millimoles per liter
Standard Deviation 0.103
|
-0.02 Millimoles per liter
Standard Deviation 0.041
|
-0.05 Millimoles per liter
Standard Deviation 0.105
|
-0.15 Millimoles per liter
Standard Deviation 0.152
|
-0.12 Millimoles per liter
Standard Deviation 0.147
|
-0.22 Millimoles per liter
Standard Deviation 0.084
|
-0.08 Millimoles per liter
Standard Deviation 0.174
|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
HDL cholesterol, FU (Day 15), n=6,6,6,6,5,6,6,6,16
|
-0.05 Millimoles per liter
Standard Deviation 0.105
|
-0.02 Millimoles per liter
Standard Deviation 0.264
|
-0.03 Millimoles per liter
Standard Deviation 0.103
|
0.07 Millimoles per liter
Standard Deviation 0.137
|
-0.05 Millimoles per liter
Standard Deviation 0.122
|
-0.02 Millimoles per liter
Standard Deviation 0.160
|
0.00 Millimoles per liter
Standard Deviation 0.179
|
-0.18 Millimoles per liter
Standard Deviation 0.148
|
0.00 Millimoles per liter
Standard Deviation 0.219
|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
LDL cholesterol,Day1, 96hours,n=5,6,6,6,5,6,6,6,14
|
-0.03 Millimoles per liter
Standard Deviation 0.361
|
0.43 Millimoles per liter
Standard Deviation 0.441
|
0.25 Millimoles per liter
Standard Deviation 0.281
|
0.30 Millimoles per liter
Standard Deviation 0.122
|
0.10 Millimoles per liter
Standard Deviation 0.562
|
-0.12 Millimoles per liter
Standard Deviation 0.519
|
-0.13 Millimoles per liter
Standard Deviation 0.408
|
-0.04 Millimoles per liter
Standard Deviation 0.428
|
0.16 Millimoles per liter
Standard Deviation 0.386
|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
LDL cholesterol, FU(Day 15), n=6,6,6,6,5,6,6,6,16
|
-0.35 Millimoles per liter
Standard Deviation 0.451
|
0.37 Millimoles per liter
Standard Deviation 0.308
|
0.07 Millimoles per liter
Standard Deviation 0.327
|
0.30 Millimoles per liter
Standard Deviation 0.210
|
0.15 Millimoles per liter
Standard Deviation 0.295
|
0.22 Millimoles per liter
Standard Deviation 0.564
|
0.07 Millimoles per liter
Standard Deviation 0.314
|
-0.14 Millimoles per liter
Standard Deviation 0.472
|
0.13 Millimoles per liter
Standard Deviation 0.491
|
|
Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides
Triglycerides, FU (Day 15),n=6,6,6,6,5,6,6,6,16
|
0.02 Millimoles per liter
Standard Deviation 0.279
|
-0.55 Millimoles per liter
Standard Deviation 0.501
|
0.40 Millimoles per liter
Standard Deviation 0.410
|
-0.20 Millimoles per liter
Standard Deviation 0.297
|
0.32 Millimoles per liter
Standard Deviation 0.838
|
-0.30 Millimoles per liter
Standard Deviation 0.303
|
0.40 Millimoles per liter
Standard Deviation 0.940
|
0.40 Millimoles per liter
Standard Deviation 0.831
|
0.05 Millimoles per liter
Standard Deviation 0.588
|
PRIMARY outcome
Timeframe: Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Chemistry Parameter: Glucose
Day 1 (96 hours), n=5,6,6,6,6,6,6,6,14
|
-0.08 Millimoles per liter
Standard Deviation 0.349
|
-0.07 Millimoles per liter
Standard Deviation 0.432
|
-0.33 Millimoles per liter
Standard Deviation 0.175
|
-0.16 Millimoles per liter
Standard Deviation 0.288
|
-0.30 Millimoles per liter
Standard Deviation 0.110
|
-0.25 Millimoles per liter
Standard Deviation 0.414
|
-0.28 Millimoles per liter
Standard Deviation 0.527
|
-0.17 Millimoles per liter
Standard Deviation 0.446
|
-0.21 Millimoles per liter
Standard Deviation 0.279
|
|
Part 1: Change From Baseline in Chemistry Parameter: Glucose
FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.27 Millimoles per liter
Standard Deviation 0.367
|
-0.27 Millimoles per liter
Standard Deviation 0.745
|
0.00 Millimoles per liter
Standard Deviation 0.374
|
-0.03 Millimoles per liter
Standard Deviation 0.513
|
-0.05 Millimoles per liter
Standard Deviation 0.345
|
-0.12 Millimoles per liter
Standard Deviation 0.605
|
-0.22 Millimoles per liter
Standard Deviation 0.471
|
0.07 Millimoles per liter
Standard Deviation 0.582
|
-0.04 Millimoles per liter
Standard Deviation 0.379
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-1.7 Grams per liter
Standard Deviation 2.94
|
-2.5 Grams per liter
Standard Deviation 1.97
|
-0.3 Grams per liter
Standard Deviation 1.37
|
-2.5 Grams per liter
Standard Deviation 2.88
|
-0.2 Grams per liter
Standard Deviation 3.37
|
-5.3 Grams per liter
Standard Deviation 3.33
|
-1.5 Grams per liter
Standard Deviation 5.32
|
0.2 Grams per liter
Standard Deviation 3.19
|
-1.2 Grams per liter
Standard Deviation 3.19
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16
|
0.3 Grams per liter
Standard Deviation 1.51
|
-0.5 Grams per liter
Standard Deviation 2.35
|
-1.6 Grams per liter
Standard Deviation 2.07
|
-2.2 Grams per liter
Standard Deviation 3.19
|
-0.8 Grams per liter
Standard Deviation 4.26
|
-4.7 Grams per liter
Standard Deviation 3.20
|
-0.7 Grams per liter
Standard Deviation 4.13
|
0.3 Grams per liter
Standard Deviation 2.50
|
-0.6 Grams per liter
Standard Deviation 2.97
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-0.2 Grams per liter
Standard Deviation 2.23
|
-2.2 Grams per liter
Standard Deviation 2.79
|
-1.05 Grams per liter
Standard Deviation 1.05
|
-3.2 Grams per liter
Standard Deviation 2.32
|
-2.5 Grams per liter
Standard Deviation 4.04
|
-3.8 Grams per liter
Standard Deviation 3.60
|
-1.3 Grams per liter
Standard Deviation 4.80
|
-1.7 Grams per liter
Standard Deviation 3.14
|
-0.6 Grams per liter
Standard Deviation 2.61
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16
|
-1.0 Grams per liter
Standard Deviation 3.10
|
2.2 Grams per liter
Standard Deviation 4.92
|
2.0 Grams per liter
Standard Deviation 2.97
|
-0.8 Grams per liter
Standard Deviation 3.43
|
3.3 Grams per liter
Standard Deviation 4.13
|
-0.8 Grams per liter
Standard Deviation 2.56
|
2.5 Grams per liter
Standard Deviation 2.88
|
1.0 Grams per liter
Standard Deviation 5.10
|
1.2 Grams per liter
Standard Deviation 4.20
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, 24 hours, n=6,6,6,6,6,6,6,6,16
|
6.8 Grams per liter
Standard Deviation 4.62
|
-0.7 Grams per liter
Standard Deviation 6.12
|
-1.5 Grams per liter
Standard Deviation 9.03
|
-7.0 Grams per liter
Standard Deviation 7.13
|
3.2 Grams per liter
Standard Deviation 5.85
|
-0.5 Grams per liter
Standard Deviation 3.62
|
0.2 Grams per liter
Standard Deviation 5.49
|
-1.2 Grams per liter
Standard Deviation 1.83
|
0.6 Grams per liter
Standard Deviation 6.83
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, 48 hours, n=6,6,6,6,6,6,6,5,16
|
6.5 Grams per liter
Standard Deviation 6.25
|
-1.7 Grams per liter
Standard Deviation 7.39
|
-2.8 Grams per liter
Standard Deviation 8.76
|
-6.7 Grams per liter
Standard Deviation 7.15
|
7.2 Grams per liter
Standard Deviation 4.96
|
-1.2 Grams per liter
Standard Deviation 2.14
|
-3.8 Grams per liter
Standard Deviation 5.34
|
0.8 Grams per liter
Standard Deviation 4.92
|
0.8 Grams per liter
Standard Deviation 6.69
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, 96 hours, n=6,6,6,6,6,6,6,6,15
|
7.2 Grams per liter
Standard Deviation 4.36
|
-5.3 Grams per liter
Standard Deviation 6.44
|
-0.7 Grams per liter
Standard Deviation 5.47
|
-2.5 Grams per liter
Standard Deviation 7.34
|
8.7 Grams per liter
Standard Deviation 4.89
|
3.2 Grams per liter
Standard Deviation 4.71
|
0.0 Grams per liter
Standard Deviation 5.33
|
0.0 Grams per liter
Standard Deviation 8.72
|
4.6 Grams per liter
Standard Deviation 7.56
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
3.0 Grams per liter
Standard Deviation 3.95
|
-0.8 Grams per liter
Standard Deviation 7.05
|
-11.2 Grams per liter
Standard Deviation 9.02
|
-2.5 Grams per liter
Standard Deviation 6.38
|
9.3 Grams per liter
Standard Deviation 7.76
|
-1.3 Grams per liter
Standard Deviation 5.09
|
-1.7 Grams per liter
Standard Deviation 7.20
|
2.5 Grams per liter
Standard Deviation 4.97
|
1.9 Grams per liter
Standard Deviation 6.69
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin, 24 hours, n=6,6,6,6,6,6,6,6,16
|
-1.0 Grams per liter
Standard Deviation 0.71
|
-1.0 Grams per liter
Standard Deviation 0.63
|
-0.3 Grams per liter
Standard Deviation 0.82
|
-1.0 Grams per liter
Standard Deviation 1.26
|
-0.5 Grams per liter
Standard Deviation 1.29
|
-1.2 Grams per liter
Standard Deviation 1.30
|
0.2 Grams per liter
Standard Deviation 1.48
|
-0.2 Grams per liter
Standard Deviation 1.10
|
-0.3 Grams per liter
Standard Deviation 1.23
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin, 48 hours, n=6,6,6,6,6,6,6,5,16
|
-0.2 Grams per liter
Standard Deviation 0.45
|
-0.5 Grams per liter
Standard Deviation 0.55
|
-0.8 Grams per liter
Standard Deviation 0.96
|
-1.0 Grams per liter
Standard Deviation 1.55
|
-0.8 Grams per liter
Standard Deviation 1.26
|
-1.2 Grams per liter
Standard Deviation 0.75
|
-0.3 Grams per liter
Standard Deviation 1.03
|
0.0 Grams per liter
Standard Deviation 0.71
|
-0.5 Grams per liter
Standard Deviation 1.10
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin, 96 hours, n=6,6,6,6,6,6,6,6,15
|
-0.2 Grams per liter
Standard Deviation 0.84
|
-0.8 Grams per liter
Standard Deviation 0.45
|
-0.8 Grams per liter
Standard Deviation 0.50
|
-0.8 Grams per liter
Standard Deviation 1.48
|
-1.0 Grams per liter
Standard Deviation 1.15
|
-0.6 Grams per liter
Standard Deviation 1.14
|
-0.3 Grams per liter
Standard Deviation 1.37
|
-0.3 Grams per liter
Standard Deviation 0.50
|
-0.3 Grams per liter
Standard Deviation 0.90
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin, FU (Day 15),n=6,6,6,6,6,6,6,6,16
|
0.0 Grams per liter
Standard Deviation 1.41
|
0.5 Grams per liter
Standard Deviation 1.52
|
0.7 Grams per liter
Standard Deviation 1.37
|
-0.7 Grams per liter
Standard Deviation 1.21
|
1.0 Grams per liter
Standard Deviation 1.22
|
0.2 Grams per liter
Standard Deviation 0.75
|
1.0 Grams per liter
Standard Deviation 0.89
|
0.8 Grams per liter
Standard Deviation 0.96
|
0.4 Grams per liter
Standard Deviation 1.36
|
PRIMARY outcome
Timeframe: Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein
FU (Day 15),n=6,6,6,6,6,6,6,6,16
|
1.7 Grams per liter
Standard Deviation 2.42
|
-1.7 Grams per liter
Standard Deviation 3.98
|
1.7 Grams per liter
Standard Deviation 1.86
|
-0.5 Grams per liter
Standard Deviation 3.62
|
0.7 Grams per liter
Standard Deviation 2.25
|
-1.3 Grams per liter
Standard Deviation 6.31
|
0.2 Grams per liter
Standard Deviation 3.66
|
-2.7 Grams per liter
Standard Deviation 3.20
|
1.5 Grams per liter
Standard Deviation 3.85
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein
24 hours, n=6,6,6,6,6,6,6,6,16
|
0.7 Grams per liter
Standard Deviation 1.21
|
0.3 Grams per liter
Standard Deviation 2.73
|
2.3 Grams per liter
Standard Deviation 2.25
|
-0.3 Grams per liter
Standard Deviation 3.39
|
2.5 Grams per liter
Standard Deviation 0.84
|
-5.2 Grams per liter
Standard Deviation 3.76
|
-1.0 Grams per liter
Standard Deviation 3.16
|
-1.2 Grams per liter
Standard Deviation 1.72
|
-0.8 Grams per liter
Standard Deviation 2.37
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein
48 hours, n=6,6,6,6,6,6,6,5,16
|
2.2 Grams per liter
Standard Deviation 1.33
|
-0.3 Grams per liter
Standard Deviation 3.88
|
1.8 Grams per liter
Standard Deviation 2.28
|
0.7 Grams per liter
Standard Deviation 5.16
|
0.0 Grams per liter
Standard Deviation 1.26
|
-4.0 Grams per liter
Standard Deviation 4.05
|
-2.3 Grams per liter
Standard Deviation 2.42
|
0.3 Grams per liter
Standard Deviation 1.51
|
0.2 Grams per liter
Standard Deviation 3.31
|
|
Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein
96 hours, n=6,6,6,6,6,6,6,6,15
|
0.8 Grams per liter
Standard Deviation 1.94
|
-0.3 Grams per liter
Standard Deviation 2.94
|
0.8 Grams per liter
Standard Deviation 3.60
|
1.2 Grams per liter
Standard Deviation 3.60
|
1.5 Grams per liter
Standard Deviation 3.39
|
-2.0 Grams per liter
Standard Deviation 4.73
|
1.0 Grams per liter
Standard Deviation 4.10
|
-1.7 Grams per liter
Standard Deviation 5.20
|
1.3 Grams per liter
Standard Deviation 3.75
|
PRIMARY outcome
Timeframe: Up to Day 15Population: Safety Population.
Urine samples were collected at given time points to analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP,72 hours, n=6,6,6,6,6,6,6,6,16
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 2.73
|
2.3 Millimeters of mercury (mmHg)
Standard Deviation 8.71
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 6.56
|
-3.2 Millimeters of mercury (mmHg)
Standard Deviation 6.08
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 6.00
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 7.17
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 6.84
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 5.09
|
4.3 Millimeters of mercury (mmHg)
Standard Deviation 8.02
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 2 hours, n=6,6,6,6,6,6,6,6,16
|
-3.3 Millimeters of mercury (mmHg)
Standard Deviation 3.93
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 10.45
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 2.35
|
-7.5 Millimeters of mercury (mmHg)
Standard Deviation 8.96
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 3.27
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 4.24
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 6.83
|
-2.7 Millimeters of mercury (mmHg)
Standard Deviation 3.08
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 8.42
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 5.56
|
6.2 Millimeters of mercury (mmHg)
Standard Deviation 8.04
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 4.63
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 3.01
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 3.78
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 5.35
|
2.8 Millimeters of mercury (mmHg)
Standard Deviation 7.44
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 4.00
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 9.16
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 96 hours, n=6,6,6,6,6,6,6,6,15
|
2.3 Millimeters of mercury (mmHg)
Standard Deviation 6.06
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 12.63
|
-0.2 Millimeters of mercury (mmHg)
Standard Deviation 5.42
|
-2.1 Millimeters of mercury (mmHg)
Standard Deviation 6.59
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 3.10
|
5.0 Millimeters of mercury (mmHg)
Standard Deviation 6.69
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 8.02
|
2.7 Millimeters of mercury (mmHg)
Standard Deviation 3.78
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation 7.39
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 5.20
|
7.3 Millimeters of mercury (mmHg)
Standard Deviation 3.83
|
7.3 Millimeters of mercury (mmHg)
Standard Deviation 5.35
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 12.56
|
-4.5 Millimeters of mercury (mmHg)
Standard Deviation 5.50
|
6.8 Millimeters of mercury (mmHg)
Standard Deviation 4.88
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 7.37
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 6.19
|
7.1 Millimeters of mercury (mmHg)
Standard Deviation 9.92
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 1 hour n=6,6,6,6,6,6,6,6,16
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 11.07
|
5.8 Millimeters of mercury (mmHg)
Standard Deviation 10.57
|
3.5 Millimeters of mercury (mmHg)
Standard Deviation 4.93
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 11.67
|
3.2 Millimeters of mercury (mmHg)
Standard Deviation 4.45
|
6.3 Millimeters of mercury (mmHg)
Standard Deviation 6.22
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 6.77
|
6.2 Millimeters of mercury (mmHg)
Standard Deviation 7.63
|
8.1 Millimeters of mercury (mmHg)
Standard Deviation 7.25
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 2 hours n=6,6,6,6,6,6,6,6,16
|
5.5 Millimeters of mercury (mmHg)
Standard Deviation 8.46
|
5.7 Millimeters of mercury (mmHg)
Standard Deviation 14.02
|
6.2 Millimeters of mercury (mmHg)
Standard Deviation 6.11
|
-0.7 Millimeters of mercury (mmHg)
Standard Deviation 7.84
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 4.17
|
8.8 Millimeters of mercury (mmHg)
Standard Deviation 3.06
|
10.7 Millimeters of mercury (mmHg)
Standard Deviation 6.62
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 7.50
|
4.4 Millimeters of mercury (mmHg)
Standard Deviation 8.05
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16
|
10.8 Millimeters of mercury (mmHg)
Standard Deviation 9.81
|
8.7 Millimeters of mercury (mmHg)
Standard Deviation 11.04
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation 6.84
|
1.8 Millimeters of mercury (mmHg)
Standard Deviation 7.22
|
5.3 Millimeters of mercury (mmHg)
Standard Deviation 5.20
|
8.8 Millimeters of mercury (mmHg)
Standard Deviation 5.60
|
5.3 Millimeters of mercury (mmHg)
Standard Deviation 6.12
|
6.7 Millimeters of mercury (mmHg)
Standard Deviation 7.42
|
7.4 Millimeters of mercury (mmHg)
Standard Deviation 11.04
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 6 hours n=6,6,6,6,6,6,6,6,16
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation 10.47
|
5.8 Millimeters of mercury (mmHg)
Standard Deviation 12.81
|
6.5 Millimeters of mercury (mmHg)
Standard Deviation 6.09
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 5.75
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 6.41
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 4.63
|
9.5 Millimeters of mercury (mmHg)
Standard Deviation 7.06
|
2.8 Millimeters of mercury (mmHg)
Standard Deviation 7.73
|
8.3 Millimeters of mercury (mmHg)
Standard Deviation 10.97
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 12 hours n=6,6,6,6,6,6,6,6,16
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 7.23
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 17.62
|
6.3 Millimeters of mercury (mmHg)
Standard Deviation 3.39
|
3.8 Millimeters of mercury (mmHg)
Standard Deviation 6.24
|
8.7 Millimeters of mercury (mmHg)
Standard Deviation 6.77
|
10.2 Millimeters of mercury (mmHg)
Standard Deviation 5.04
|
8.2 Millimeters of mercury (mmHg)
Standard Deviation 6.62
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 8.29
|
7.6 Millimeters of mercury (mmHg)
Standard Deviation 7.90
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 24 hours n=6,6,6,6,6,6,6,6,16
|
2.7 Millimeters of mercury (mmHg)
Standard Deviation 5.72
|
5.8 Millimeters of mercury (mmHg)
Standard Deviation 8.30
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 7.57
|
-1.5 Millimeters of mercury (mmHg)
Standard Deviation 5.54
|
3.2 Millimeters of mercury (mmHg)
Standard Deviation 2.79
|
9.0 Millimeters of mercury (mmHg)
Standard Deviation 6.32
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 7.58
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 4.46
|
5.1 Millimeters of mercury (mmHg)
Standard Deviation 10.68
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 48 hours n=6,6,6,6,6,6,6,6,16
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 7.50
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 6.98
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 9.24
|
-4.3 Millimeters of mercury (mmHg)
Standard Deviation 6.59
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 5.35
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 8.22
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 9.79
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 11.45
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 8.68
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 4.5 hours, n=6,6,6,6,6,6,6,6,16
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 4.55
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 6.31
|
6.3 Millimeters of mercury (mmHg)
Standard Deviation 8.16
|
-4.8 Millimeters of mercury (mmHg)
Standard Deviation 6.91
|
2.3 Millimeters of mercury (mmHg)
Standard Deviation 6.44
|
6.7 Millimeters of mercury (mmHg)
Standard Deviation 6.77
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 6.83
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 3.06
|
6.8 Millimeters of mercury (mmHg)
Standard Deviation 10.10
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP,72 hours n=6,6,6,6,6,6,6,6,16
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 6.00
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 11.93
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 12.02
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 5.66
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 7.24
|
-0.8 Millimeters of mercury (mmHg)
Standard Deviation 5.49
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 8.52
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation 6.57
|
2.4 Millimeters of mercury (mmHg)
Standard Deviation 6.13
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, 96 hours n=6,6,6,6,6,6,6,6,15
|
6.3 Millimeters of mercury (mmHg)
Standard Deviation 7.53
|
2.5 Millimeters of mercury (mmHg)
Standard Deviation 14.34
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 6.19
|
1.8 Millimeters of mercury (mmHg)
Standard Deviation 5.42
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 5.35
|
6.0 Millimeters of mercury (mmHg)
Standard Deviation 11.40
|
5.3 Millimeters of mercury (mmHg)
Standard Deviation 12.71
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 5.80
|
4.5 Millimeters of mercury (mmHg)
Standard Deviation 9.02
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, FU(Day 15), n=6,6,6,6,6,6,6,6,16
|
4.5 Millimeters of mercury (mmHg)
Standard Deviation 6.02
|
11.5 Millimeters of mercury (mmHg)
Standard Deviation 3.33
|
7.8 Millimeters of mercury (mmHg)
Standard Deviation 4.22
|
6.7 Millimeters of mercury (mmHg)
Standard Deviation 9.18
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 7.69
|
11.5 Millimeters of mercury (mmHg)
Standard Deviation 7.92
|
6.8 Millimeters of mercury (mmHg)
Standard Deviation 7.22
|
4.5 Millimeters of mercury (mmHg)
Standard Deviation 10.21
|
7.3 Millimeters of mercury (mmHg)
Standard Deviation 10.20
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 1 hour n=6,6,6,6,6,6,6,6,16
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 4.56
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 9.87
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 2.88
|
-3.2 Millimeters of mercury (mmHg)
Standard Deviation 8.84
|
-3.7 Millimeters of mercury (mmHg)
Standard Deviation 2.07
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 6.18
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 5.53
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 4.32
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 8.62
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 6 hours, n=6,6,6,6,6,6,6,6,16
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 6.48
|
1.8 Millimeters of mercury (mmHg)
Standard Deviation 9.15
|
3.2 Millimeters of mercury (mmHg)
Standard Deviation 7.78
|
-3.5 Millimeters of mercury (mmHg)
Standard Deviation 4.42
|
-3.7 Millimeters of mercury (mmHg)
Standard Deviation 4.93
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 5.71
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 3.74
|
-2.2 Millimeters of mercury (mmHg)
Standard Deviation 5.15
|
2.4 Millimeters of mercury (mmHg)
Standard Deviation 9.76
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 12 hours, n=6,6,6,6,6,6,6,6,16
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 6.10
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 12.61
|
5.3 Millimeters of mercury (mmHg)
Standard Deviation 3.83
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 8.23
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 2.58
|
4.2 Millimeters of mercury (mmHg)
Standard Deviation 3.76
|
4.3 Millimeters of mercury (mmHg)
Standard Deviation 9.09
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 5.10
|
4.8 Millimeters of mercury (mmHg)
Standard Deviation 7.64
|
|
Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, 48 hours, n=6,6,6,6,6,6,6,6,16
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 5.43
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 8.71
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 4.73
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation 6.29
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 6.56
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 5.29
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 7.56
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 5.65
|
4.3 Millimeters of mercury (mmHg)
Standard Deviation 8.90
|
PRIMARY outcome
Timeframe: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
1 hour n=6,6,6,6,6,6,6,6,16
|
7.5 Beats per minute
Standard Deviation 3.67
|
9.0 Beats per minute
Standard Deviation 3.85
|
7.0 Beats per minute
Standard Deviation 2.97
|
13.3 Beats per minute
Standard Deviation 6.71
|
5.2 Beats per minute
Standard Deviation 2.48
|
14.5 Beats per minute
Standard Deviation 4.04
|
13.7 Beats per minute
Standard Deviation 5.05
|
11.3 Beats per minute
Standard Deviation 4.80
|
9.6 Beats per minute
Standard Deviation 6.97
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
2 hours, n=6,6,6,6,6,6,6,6,16
|
6.0 Beats per minute
Standard Deviation 3.22
|
7.0 Beats per minute
Standard Deviation 5.80
|
3.7 Beats per minute
Standard Deviation 9.65
|
7.3 Beats per minute
Standard Deviation 4.89
|
3.2 Beats per minute
Standard Deviation 4.96
|
6.8 Beats per minute
Standard Deviation 4.75
|
10.7 Beats per minute
Standard Deviation 9.09
|
12.8 Beats per minute
Standard Deviation 6.05
|
8.2 Beats per minute
Standard Deviation 3.99
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
4.5 hours, n=6,6,6,6,6,6,6,6,16
|
5.5 Beats per minute
Standard Deviation 3.94
|
4.2 Beats per minute
Standard Deviation 8.08
|
6.2 Beats per minute
Standard Deviation 6.85
|
6.5 Beats per minute
Standard Deviation 6.72
|
2.0 Beats per minute
Standard Deviation 7.56
|
3.7 Beats per minute
Standard Deviation 1.97
|
5.8 Beats per minute
Standard Deviation 4.40
|
8.2 Beats per minute
Standard Deviation 11.97
|
6.4 Beats per minute
Standard Deviation 5.94
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
6 hours,n=6,6,6,6,6,6,6,6,16
|
7.7 Beats per minute
Standard Deviation 3.88
|
8.3 Beats per minute
Standard Deviation 4.72
|
8.0 Beats per minute
Standard Deviation 3.16
|
16.8 Beats per minute
Standard Deviation 7.41
|
7.7 Beats per minute
Standard Deviation 5.85
|
9.7 Beats per minute
Standard Deviation 3.98
|
11.3 Beats per minute
Standard Deviation 6.02
|
11.2 Beats per minute
Standard Deviation 6.65
|
10.4 Beats per minute
Standard Deviation 6.59
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
12 hours, n=6,6,6,6,6,6,6,6,16
|
6.5 Beats per minute
Standard Deviation 8.96
|
8.0 Beats per minute
Standard Deviation 11.26
|
6.0 Beats per minute
Standard Deviation 7.51
|
10.2 Beats per minute
Standard Deviation 4.40
|
5.7 Beats per minute
Standard Deviation 7.55
|
11.8 Beats per minute
Standard Deviation 6.85
|
9.0 Beats per minute
Standard Deviation 5.83
|
11.0 Beats per minute
Standard Deviation 4.90
|
7.3 Beats per minute
Standard Deviation 5.61
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
24 hours, n=6,6,6,6,6,6,6,6,16
|
2.5 Beats per minute
Standard Deviation 5.68
|
5.8 Beats per minute
Standard Deviation 10.38
|
1.0 Beats per minute
Standard Deviation 4.86
|
5.2 Beats per minute
Standard Deviation 4.58
|
3.3 Beats per minute
Standard Deviation 4.37
|
2.3 Beats per minute
Standard Deviation 6.56
|
4.5 Beats per minute
Standard Deviation 9.48
|
6.7 Beats per minute
Standard Deviation 10.15
|
0.2 Beats per minute
Standard Deviation 3.89
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
48 hours, n=6,6,6,6,6,6,6,6,16
|
-2.3 Beats per minute
Standard Deviation 6.83
|
10.8 Beats per minute
Standard Deviation 15.89
|
1.5 Beats per minute
Standard Deviation 6.35
|
0.8 Beats per minute
Standard Deviation 5.67
|
3.5 Beats per minute
Standard Deviation 7.31
|
3.2 Beats per minute
Standard Deviation 4.58
|
4.5 Beats per minute
Standard Deviation 6.89
|
4.8 Beats per minute
Standard Deviation 6.46
|
1.5 Beats per minute
Standard Deviation 3.88
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
72 hours, n=6,6,6,6,6,6,6,6,16
|
-0.3 Beats per minute
Standard Deviation 6.19
|
4.5 Beats per minute
Standard Deviation 6.28
|
-0.2 Beats per minute
Standard Deviation 7.14
|
2.0 Beats per minute
Standard Deviation 8.58
|
3.8 Beats per minute
Standard Deviation 5.00
|
2.8 Beats per minute
Standard Deviation 4.31
|
6.8 Beats per minute
Standard Deviation 4.49
|
2.0 Beats per minute
Standard Deviation 3.29
|
1.4 Beats per minute
Standard Deviation 5.40
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
96 hours, n=6,6,6,6,6,6,6,6,15
|
4.0 Beats per minute
Standard Deviation 2.45
|
2.8 Beats per minute
Standard Deviation 4.54
|
8.0 Beats per minute
Standard Deviation 4.47
|
12.5 Beats per minute
Standard Deviation 12.93
|
4.8 Beats per minute
Standard Deviation 4.83
|
4.8 Beats per minute
Standard Deviation 5.15
|
9.2 Beats per minute
Standard Deviation 6.88
|
5.7 Beats per minute
Standard Deviation 4.37
|
2.5 Beats per minute
Standard Deviation 4.29
|
|
Part 1: Change From Baseline in Vital Signs: Pulse Rate
FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
-0.7 Beats per minute
Standard Deviation 11.93
|
4.8 Beats per minute
Standard Deviation 6.97
|
6.3 Beats per minute
Standard Deviation 8.24
|
6.2 Beats per minute
Standard Deviation 4.71
|
3.3 Beats per minute
Standard Deviation 8.07
|
3.2 Beats per minute
Standard Deviation 6.52
|
6.3 Beats per minute
Standard Deviation 10.07
|
3.5 Beats per minute
Standard Deviation 3.99
|
1.3 Beats per minute
Standard Deviation 5.74
|
PRIMARY outcome
Timeframe: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Vital Signs: Temperature
1 hour, n=6,6,6,6,6,6,6,6,16
|
0.00 Degree Celsius
Standard Deviation 0.245
|
0.28 Degree Celsius
Standard Deviation 0.256
|
0.22 Degree Celsius
Standard Deviation 0.407
|
0.33 Degree Celsius
Standard Deviation 0.186
|
0.15 Degree Celsius
Standard Deviation 0.378
|
0.03 Degree Celsius
Standard Deviation 0.333
|
0.18 Degree Celsius
Standard Deviation 0.376
|
0.10 Degree Celsius
Standard Deviation 0.303
|
0.19 Degree Celsius
Standard Deviation 0.267
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
2 hours, n=6,6,6,6,6,6,6,6,16
|
0.27 Degree Celsius
Standard Deviation 0.250
|
0.17 Degree Celsius
Standard Deviation 0.388
|
0.52 Degree Celsius
Standard Deviation 0.279
|
0.20 Degree Celsius
Standard Deviation 0.237
|
0.00 Degree Celsius
Standard Deviation 0.322
|
0.15 Degree Celsius
Standard Deviation 0.378
|
0.28 Degree Celsius
Standard Deviation 0.256
|
0.02 Degree Celsius
Standard Deviation 0.256
|
0.23 Degree Celsius
Standard Deviation 0.322
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
4.5 hours, n=6,6,6,6,6,6,6,6,16
|
0.45 Degree Celsius
Standard Deviation 0.321
|
0.33 Degree Celsius
Standard Deviation 0.308
|
0.42 Degree Celsius
Standard Deviation 0.426
|
0.35 Degree Celsius
Standard Deviation 0.308
|
0.23 Degree Celsius
Standard Deviation 0.356
|
0.03 Degree Celsius
Standard Deviation 0.350
|
0.07 Degree Celsius
Standard Deviation 0.280
|
0.12 Degree Celsius
Standard Deviation 0.360
|
0.22 Degree Celsius
Standard Deviation 0.299
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
6 hours, n=6,6,6,6,6,6,6,6,16
|
0.45 Degree Celsius
Standard Deviation 0.394
|
0.38 Degree Celsius
Standard Deviation 0.264
|
0.75 Degree Celsius
Standard Deviation 0.217
|
0.45 Degree Celsius
Standard Deviation 0.274
|
0.27 Degree Celsius
Standard Deviation 0.234
|
0.15 Degree Celsius
Standard Deviation 0.339
|
0.42 Degree Celsius
Standard Deviation 0.223
|
0.20 Degree Celsius
Standard Deviation 0.210
|
0.29 Degree Celsius
Standard Deviation 0.390
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
12 hours, n=6,6,6,6,6,6,6,6,16
|
0.18 Degree Celsius
Standard Deviation 0.426
|
0.07 Degree Celsius
Standard Deviation 0.175
|
0.53 Degree Celsius
Standard Deviation 0.398
|
0.30 Degree Celsius
Standard Deviation 0.219
|
0.20 Degree Celsius
Standard Deviation 0.261
|
0.17 Degree Celsius
Standard Deviation 0.350
|
0.20 Degree Celsius
Standard Deviation 0.283
|
0.27 Degree Celsius
Standard Deviation 0.493
|
0.12 Degree Celsius
Standard Deviation 0.259
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
24 hours, n=6,6,6,6,6,6,6,6,16
|
0.10 Degree Celsius
Standard Deviation 0.310
|
0.17 Degree Celsius
Standard Deviation 0.103
|
0.23 Degree Celsius
Standard Deviation 0.427
|
-0.13 Degree Celsius
Standard Deviation 0.266
|
0.10 Degree Celsius
Standard Deviation 0.210
|
0.07 Degree Celsius
Standard Deviation 0.175
|
0.05 Degree Celsius
Standard Deviation 0.105
|
0.05 Degree Celsius
Standard Deviation 0.596
|
0.03 Degree Celsius
Standard Deviation 0.244
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
48 hours, n=6,6,6,6,6,6,6,6,16
|
-0.03 Degree Celsius
Standard Deviation 0.463
|
0.42 Degree Celsius
Standard Deviation 0.694
|
0.27 Degree Celsius
Standard Deviation 0.489
|
-0.03 Degree Celsius
Standard Deviation 0.234
|
0.10 Degree Celsius
Standard Deviation 0.460
|
-0.18 Degree Celsius
Standard Deviation 0.214
|
0.07 Degree Celsius
Standard Deviation 0.356
|
-0.17 Degree Celsius
Standard Deviation 0.250
|
0.04 Degree Celsius
Standard Deviation 0.301
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
72 hours, n=6,6,6,6,6,6,6,6,16
|
0.17 Degree Celsius
Standard Deviation 0.446
|
0.25 Degree Celsius
Standard Deviation 0.217
|
0.15 Degree Celsius
Standard Deviation 0.362
|
0.10 Degree Celsius
Standard Deviation 0.110
|
0.23 Degree Celsius
Standard Deviation 0.427
|
0.00 Degree Celsius
Standard Deviation 0.316
|
0.18 Degree Celsius
Standard Deviation 0.306
|
-0.12 Degree Celsius
Standard Deviation 0.488
|
0.03 Degree Celsius
Standard Deviation 0.317
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
96 hours, n=6,6,6,6,6,6,6,6,15
|
0.22 Degree Celsius
Standard Deviation 0.402
|
0.17 Degree Celsius
Standard Deviation 0.216
|
0.08 Degree Celsius
Standard Deviation 0.240
|
0.02 Degree Celsius
Standard Deviation 0.232
|
0.10 Degree Celsius
Standard Deviation 0.255
|
0.12 Degree Celsius
Standard Deviation 0.160
|
-0.18 Degree Celsius
Standard Deviation 0.214
|
-0.17 Degree Celsius
Standard Deviation 0.628
|
-0.07 Degree Celsius
Standard Deviation 0.313
|
|
Part 1: Change From Baseline in Vital Signs: Temperature
FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0.13 Degree Celsius
Standard Deviation 0.344
|
0.18 Degree Celsius
Standard Deviation 0.293
|
0.47 Degree Celsius
Standard Deviation 0.398
|
0.05 Degree Celsius
Standard Deviation 0.327
|
-0.03 Degree Celsius
Standard Deviation 0.344
|
0.12 Degree Celsius
Standard Deviation 0.331
|
0.00 Degree Celsius
Standard Deviation 0.518
|
0.20 Degree Celsius
Standard Deviation 0.506
|
0.11 Degree Celsius
Standard Deviation 0.344
|
PRIMARY outcome
Timeframe: Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
6 hours, n=6,6,6,6,6,6,6,6,16
|
0.7 Breaths per minute
Standard Deviation 2.73
|
0.5 Breaths per minute
Standard Deviation 1.97
|
1.3 Breaths per minute
Standard Deviation 1.75
|
0.7 Breaths per minute
Standard Deviation 1.97
|
0.3 Breaths per minute
Standard Deviation 2.34
|
-1.7 Breaths per minute
Standard Deviation 1.86
|
2.3 Breaths per minute
Standard Deviation 2.80
|
-0.2 Breaths per minute
Standard Deviation 2.04
|
1.0 Breaths per minute
Standard Deviation 3.35
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
24 hours, n=6,6,6,6,6,6,6,6,16
|
1.0 Breaths per minute
Standard Deviation 2.61
|
-0.2 Breaths per minute
Standard Deviation 0.98
|
1.5 Breaths per minute
Standard Deviation 2.07
|
0.7 Breaths per minute
Standard Deviation 1.51
|
-0.3 Breaths per minute
Standard Deviation 1.03
|
0.7 Breaths per minute
Standard Deviation 2.80
|
0.3 Breaths per minute
Standard Deviation 2.80
|
-2.0 Breaths per minute
Standard Deviation 1.67
|
0.9 Breaths per minute
Standard Deviation 2.66
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
12 hours, n=6,6,6,6,6,6,6,6,16
|
-0.2 Breaths per minute
Standard Deviation 1.33
|
1.3 Breaths per minute
Standard Deviation 2.34
|
1.0 Breaths per minute
Standard Deviation 2.53
|
2.2 Breaths per minute
Standard Deviation 2.14
|
2.8 Breaths per minute
Standard Deviation 4.26
|
2.2 Breaths per minute
Standard Deviation 4.36
|
2.7 Breaths per minute
Standard Deviation 2.34
|
-1.7 Breaths per minute
Standard Deviation 2.88
|
2.2 Breaths per minute
Standard Deviation 2.59
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
48 hours, n=6,6,6,6,6,6,6,6,16
|
1.7 Breaths per minute
Standard Deviation 1.21
|
1.7 Breaths per minute
Standard Deviation 1.37
|
0.3 Breaths per minute
Standard Deviation 2.25
|
0.7 Breaths per minute
Standard Deviation 1.97
|
-0.2 Breaths per minute
Standard Deviation 2.32
|
0.5 Breaths per minute
Standard Deviation 3.08
|
1.2 Breaths per minute
Standard Deviation 2.04
|
0.0 Breaths per minute
Standard Deviation 1.26
|
-0.3 Breaths per minute
Standard Deviation 3.15
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
72 hours, n=6,6,6,6,6,6,6,6,16
|
-0.3 Breaths per minute
Standard Deviation 1.97
|
-1.5 Breaths per minute
Standard Deviation 2.35
|
0.5 Breaths per minute
Standard Deviation 4.14
|
0.2 Breaths per minute
Standard Deviation 1.47
|
0.0 Breaths per minute
Standard Deviation 2.19
|
0.3 Breaths per minute
Standard Deviation 2.58
|
0.7 Breaths per minute
Standard Deviation 3.50
|
-0.5 Breaths per minute
Standard Deviation 2.35
|
-0.3 Breaths per minute
Standard Deviation 2.73
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
96 hours, n=6,6,6,6,6,6,6,6,15
|
0.0 Breaths per minute
Standard Deviation 1.26
|
-1.0 Breaths per minute
Standard Deviation 2.68
|
0.3 Breaths per minute
Standard Deviation 2.58
|
1.3 Breaths per minute
Standard Deviation 1.97
|
0.5 Breaths per minute
Standard Deviation 2.07
|
0.0 Breaths per minute
Standard Deviation 2.00
|
-1.0 Breaths per minute
Standard Deviation 2.37
|
0.2 Breaths per minute
Standard Deviation 4.02
|
0.3 Breaths per minute
Standard Deviation 2.37
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
FU (Day 15), n=6,6,6,6,6,6,6,6,15
|
-1.2 Breaths per minute
Standard Deviation 2.64
|
-0.5 Breaths per minute
Standard Deviation 1.87
|
1.2 Breaths per minute
Standard Deviation 2.86
|
0.2 Breaths per minute
Standard Deviation 2.71
|
-0.8 Breaths per minute
Standard Deviation 2.48
|
0.5 Breaths per minute
Standard Deviation 3.27
|
0.0 Breaths per minute
Standard Deviation 2.90
|
0.5 Breaths per minute
Standard Deviation 2.43
|
0.3 Breaths per minute
Standard Deviation 2.74
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
1 hour, n=6,6,6,6,6,6,6,6,16
|
0.3 Breaths per minute
Standard Deviation 1.51
|
0.5 Breaths per minute
Standard Deviation 1.38
|
0.8 Breaths per minute
Standard Deviation 2.04
|
1.5 Breaths per minute
Standard Deviation 1.52
|
0.8 Breaths per minute
Standard Deviation 2.14
|
-0.3 Breaths per minute
Standard Deviation 1.97
|
1.0 Breaths per minute
Standard Deviation 0.89
|
-1.0 Breaths per minute
Standard Deviation 2.37
|
0.1 Breaths per minute
Standard Deviation 2.69
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
2 hours, n=6,6,6,6,6,6,6,6,16
|
0.8 Breaths per minute
Standard Deviation 2.14
|
-0.5 Breaths per minute
Standard Deviation 3.08
|
1.3 Breaths per minute
Standard Deviation 2.25
|
1.7 Breaths per minute
Standard Deviation 1.51
|
1.3 Breaths per minute
Standard Deviation 3.27
|
1.0 Breaths per minute
Standard Deviation 2.19
|
0.7 Breaths per minute
Standard Deviation 1.37
|
0.5 Breaths per minute
Standard Deviation 1.38
|
0.3 Breaths per minute
Standard Deviation 2.02
|
|
Part 1: Change From Baseline in Vital Sign: Respiratory Rate
4.5 hours, n=6,6,6,6,6,6,6,6,16
|
0.7 Breaths per minute
Standard Deviation 1.63
|
1.0 Breaths per minute
Standard Deviation 1.41
|
0.7 Breaths per minute
Standard Deviation 2.16
|
1.8 Breaths per minute
Standard Deviation 1.72
|
0.8 Breaths per minute
Standard Deviation 3.31
|
1.7 Breaths per minute
Standard Deviation 3.20
|
0.8 Breaths per minute
Standard Deviation 1.33
|
0.3 Breaths per minute
Standard Deviation 1.21
|
1.9 Breaths per minute
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: Baseline (Day 1 predose), 1,2,4,6,12,24,48,72,96 hours post dose and Follow up (Day 15)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 Participants
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS,Day 1, 48 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, Day 1,1 hour n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, Day 1,2 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, Day 1, 4 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, Day 1, 6 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS,Day 1, 12 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, Day 1, 24 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS,Day 1, 48 hours n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, Day 1, 72 hours, n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, Day 1, 96 hour n=6,6,6,6,6,6,6,6,15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS, FU (Day 15), n=6,6,6,6,6,6,6,6,16
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants AEs and SAEs
AE
|
—
|
—
|
—
|
4 Participants
|
5 Participants
|
19 Participants
|
6 Participants
|
10 Participants
|
—
|
|
Part 2: Number of Participants AEs and SAEs
SAE
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14 : 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.170 10^9 cells/Liter
Standard Deviation 0.8864
|
0.123 10^9 cells/Liter
Standard Deviation 0.5792
|
-0.096 10^9 cells/Liter
Standard Deviation 0.9361
|
0.063 10^9 cells/Liter
Standard Deviation 0.9600
|
-0.250 10^9 cells/Liter
Standard Deviation 1.3609
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.017 10^9 cells/Liter
Standard Deviation 0.0602
|
0.013 10^9 cells/Liter
Standard Deviation 0.0468
|
0.019 10^9 cells/Liter
Standard Deviation 0.1192
|
0.048 10^9 cells/Liter
Standard Deviation 0.0794
|
0.011 10^9 cells/Liter
Standard Deviation 0.0589
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.003 10^9 cells/Liter
Standard Deviation 0.0468
|
0.047 10^9 cells/Liter
Standard Deviation 0.0513
|
0.000 10^9 cells/Liter
Standard Deviation 0.1193
|
0.048 10^9 cells/Liter
Standard Deviation 0.0893
|
0.009 10^9 cells/Liter
Standard Deviation 0.0770
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.045 10^9 cells/Liter
Standard Deviation 0.0647
|
0.043 10^9 cells/Liter
Standard Deviation 0.0437
|
0.004 10^9 cells/Liter
Standard Deviation 0.1167
|
0.050 10^9 cells/Liter
Standard Deviation 0.0851
|
0.001 10^9 cells/Liter
Standard Deviation 0.0584
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.055 10^9 cells/Liter
Standard Deviation 0.0373
|
0.017 10^9 cells/Liter
Standard Deviation 0.0659
|
-0.003 10^9 cells/Liter
Standard Deviation 0.1617
|
0.023 10^9 cells/Liter
Standard Deviation 0.0804
|
-0.041 10^9 cells/Liter
Standard Deviation 0.0618
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.203 10^9 cells/Liter
Standard Deviation 0.8721
|
0.275 10^9 cells/Liter
Standard Deviation 0.4329
|
0.355 10^9 cells/Liter
Standard Deviation 1.6576
|
-0.081 10^9 cells/Liter
Standard Deviation 0.4831
|
-0.202 10^9 cells/Liter
Standard Deviation 1.2439
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.158 10^9 cells/Liter
Standard Deviation 1.1274
|
0.052 10^9 cells/Liter
Standard Deviation 0.4839
|
0.100 10^9 cells/Liter
Standard Deviation 1.3054
|
-0.347 10^9 cells/Liter
Standard Deviation 0.6065
|
-0.026 10^9 cells/Liter
Standard Deviation 1.3748
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.043 10^9 cells/Liter
Standard Deviation 0.8500
|
0.178 10^9 cells/Liter
Standard Deviation 0.6011
|
-0.011 10^9 cells/Liter
Standard Deviation 0.9496
|
-0.481 10^9 cells/Liter
Standard Deviation 1.2000
|
-0.144 10^9 cells/Liter
Standard Deviation 1.3225
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.117 10^9 cells/Liter
Standard Deviation 0.8565
|
0.515 10^9 cells/Liter
Standard Deviation 0.4821
|
0.296 10^9 cells/Liter
Standard Deviation 0.8216
|
-0.584 10^9 cells/Liter
Standard Deviation 1.1299
|
0.064 10^9 cells/Liter
Standard Deviation 1.5507
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.538 10^9 cells/Liter
Standard Deviation 1.0626
|
0.810 10^9 cells/Liter
Standard Deviation 0.4692
|
0.165 10^9 cells/Liter
Standard Deviation 0.8511
|
-0.567 10^9 cells/Liter
Standard Deviation 1.2112
|
-0.052 10^9 cells/Liter
Standard Deviation 1.4813
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.200 10^9 cells/Liter
Standard Deviation 0.8402
|
-0.053 10^9 cells/Liter
Standard Deviation 0.4230
|
0.180 10^9 cells/Liter
Standard Deviation 1.0249
|
-0.433 10^9 cells/Liter
Standard Deviation 0.9609
|
0.046 10^9 cells/Liter
Standard Deviation 1.3461
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.028 10^9 cells/Liter
Standard Deviation 0.7348
|
0.187 10^9 cells/Liter
Standard Deviation 0.4774
|
0.097 10^9 cells/Liter
Standard Deviation 1.0672
|
-0.597 10^9 cells/Liter
Standard Deviation 1.2776
|
0.104 10^9 cells/Liter
Standard Deviation 1.2821
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.438 10^9 cells/Liter
Standard Deviation 1.0624
|
0.300 10^9 cells/Liter
Standard Deviation 0.4367
|
0.336 10^9 cells/Liter
Standard Deviation 1.1083
|
-0.248 10^9 cells/Liter
Standard Deviation 1.6414
|
0.347 10^9 cells/Liter
Standard Deviation 1.3089
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Leukocytes, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-1.148 10^9 cells/Liter
Standard Deviation 0.7008
|
0.263 10^9 cells/Liter
Standard Deviation 1.6261
|
-0.209 10^9 cells/Liter
Standard Deviation 0.8990
|
-0.709 10^9 cells/Liter
Standard Deviation 1.2790
|
-0.049 10^9 cells/Liter
Standard Deviation 1.1939
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.003 10^9 cells/Liter
Standard Deviation 0.4892
|
0.092 10^9 cells/Liter
Standard Deviation 0.4111
|
0.013 10^9 cells/Liter
Standard Deviation 0.3249
|
0.163 10^9 cells/Liter
Standard Deviation 0.3174
|
-0.026 10^9 cells/Liter
Standard Deviation 0.4478
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.008 10^9 cells/Liter
Standard Deviation 0.6814
|
-0.067 10^9 cells/Liter
Standard Deviation 0.5230
|
0.000 10^9 cells/Liter
Standard Deviation 0.3242
|
0.194 10^9 cells/Liter
Standard Deviation 0.4500
|
-0.003 10^9 cells/Liter
Standard Deviation 0.4739
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.053 10^9 cells/Liter
Standard Deviation 0.7320
|
0.185 10^9 cells/Liter
Standard Deviation 0.5404
|
0.232 10^9 cells/Liter
Standard Deviation 0.3580
|
0.190 10^9 cells/Liter
Standard Deviation 0.5199
|
0.085 10^9 cells/Liter
Standard Deviation 0.4055
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.177 10^9 cells/Liter
Standard Deviation 0.7096
|
0.332 10^9 cells/Liter
Standard Deviation 0.3874
|
0.180 10^9 cells/Liter
Standard Deviation 0.4106
|
0.231 10^9 cells/Liter
Standard Deviation 0.5225
|
0.054 10^9 cells/Liter
Standard Deviation 0.5013
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.035 10^9 cells/Liter
Standard Deviation 0.7416
|
-0.017 10^9 cells/Liter
Standard Deviation 0.5384
|
0.147 10^9 cells/Liter
Standard Deviation 0.3174
|
0.210 10^9 cells/Liter
Standard Deviation 0.5157
|
0.112 10^9 cells/Liter
Standard Deviation 0.3739
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.035 10^9 cells/Liter
Standard Deviation 0.6427
|
0.100 10^9 cells/Liter
Standard Deviation 0.5655
|
0.140 10^9 cells/Liter
Standard Deviation 0.2862
|
0.229 10^9 cells/Liter
Standard Deviation 0.4557
|
0.013 10^9 cells/Liter
Standard Deviation 0.4660
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-0.078 10^9 cells/Liter
Standard Deviation 0.5286
|
-0.055 10^9 cells/Liter
Standard Deviation 0.4773
|
0.186 10^9 cells/Liter
Standard Deviation 0.2944
|
0.125 10^9 cells/Liter
Standard Deviation 0.4923
|
0.061 10^9 cells/Liter
Standard Deviation 0.4643
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.022 10^9 cells/Liter
Standard Deviation 0.5561
|
0.135 10^9 cells/Liter
Standard Deviation 0.3746
|
0.180 10^9 cells/Liter
Standard Deviation 0.3403
|
0.072 10^9 cells/Liter
Standard Deviation 0.4776
|
0.044 10^9 cells/Liter
Standard Deviation 0.4554
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.060 10^9 cells/Liter
Standard Deviation 0.5114
|
0.255 10^9 cells/Liter
Standard Deviation 0.4602
|
0.247 10^9 cells/Liter
Standard Deviation 0.3308
|
0.193 10^9 cells/Liter
Standard Deviation 0.7185
|
0.059 10^9 cells/Liter
Standard Deviation 0.4478
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Lymphocytes, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.512 10^9 cells/Liter
Standard Deviation 0.5189
|
-0.280 10^9 cells/Liter
Standard Deviation 0.5637
|
-0.144 10^9 cells/Liter
Standard Deviation 0.4368
|
-0.237 10^9 cells/Liter
Standard Deviation 0.3583
|
-0.184 10^9 cells/Liter
Standard Deviation 0.2858
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.003 10^9 cells/Liter
Standard Deviation 0.1046
|
-0.038 10^9 cells/Liter
Standard Deviation 0.0791
|
0.011 10^9 cells/Liter
Standard Deviation 0.1690
|
-0.026 10^9 cells/Liter
Standard Deviation 0.0948
|
-0.042 10^9 cells/Liter
Standard Deviation 0.0982
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.023 10^9 cells/Liter
Standard Deviation 0.0804
|
-0.037 10^9 cells/Liter
Standard Deviation 0.0905
|
-0.001 10^9 cells/Liter
Standard Deviation 0.1085
|
-0.023 10^9 cells/Liter
Standard Deviation 0.1052
|
-0.029 10^9 cells/Liter
Standard Deviation 0.1018
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.030 10^9 cells/Liter
Standard Deviation 0.1489
|
-0.075 10^9 cells/Liter
Standard Deviation 0.0817
|
-0.019 10^9 cells/Liter
Standard Deviation 0.1169
|
-0.067 10^9 cells/Liter
Standard Deviation 0.0808
|
-0.021 10^9 cells/Liter
Standard Deviation 0.1045
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.012 10^9 cells/Liter
Standard Deviation 0.1068
|
-0.057 10^9 cells/Liter
Standard Deviation 0.1063
|
-0.018 10^9 cells/Liter
Standard Deviation 0.1006
|
-0.001 10^9 cells/Liter
Standard Deviation 0.1192
|
-0.005 10^9 cells/Liter
Standard Deviation 0.1005
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.023 10^9 cells/Liter
Standard Deviation 0.0942
|
0.022 10^9 cells/Liter
Standard Deviation 0.1269
|
-0.002 10^9 cells/Liter
Standard Deviation 0.0926
|
-0.011 10^9 cells/Liter
Standard Deviation 0.1530
|
-0.009 10^9 cells/Liter
Standard Deviation 0.1244
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.003 10^9 cells/Liter
Standard Deviation 0.1204
|
0.020 10^9 cells/Liter
Standard Deviation 0.1115
|
0.016 10^9 cells/Liter
Standard Deviation 0.0881
|
-0.021 10^9 cells/Liter
Standard Deviation 0.1122
|
-0.001 10^9 cells/Liter
Standard Deviation 0.1356
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.037 10^9 cells/Liter
Standard Deviation 0.1084
|
-0.008 10^9 cells/Liter
Standard Deviation 0.0773
|
-0.023 10^9 cells/Liter
Standard Deviation 0.1044
|
-0.027 10^9 cells/Liter
Standard Deviation 0.1226
|
0.003 10^9 cells/Liter
Standard Deviation 0.1007
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.005 10^9 cells/Liter
Standard Deviation 0.1093
|
-0.040 10^9 cells/Liter
Standard Deviation 0.0947
|
-0.019 10^9 cells/Liter
Standard Deviation 0.1158
|
-0.050 10^9 cells/Liter
Standard Deviation 0.1352
|
0.004 10^9 cells/Liter
Standard Deviation 0.0756
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.035 10^9 cells/Liter
Standard Deviation 0.0961
|
-0.030 10^9 cells/Liter
Standard Deviation 0.1077
|
0.006 10^9 cells/Liter
Standard Deviation 0.1323
|
-0.002 10^9 cells/Liter
Standard Deviation 0.1450
|
0.038 10^9 cells/Liter
Standard Deviation 0.1207
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Monocytes, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.083 10^9 cells/Liter
Standard Deviation 0.1037
|
-0.030 10^9 cells/Liter
Standard Deviation 0.1188
|
-0.036 10^9 cells/Liter
Standard Deviation 0.0937
|
0.013 10^9 cells/Liter
Standard Deviation 0.1883
|
-0.051 10^9 cells/Liter
Standard Deviation 0.0778
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.178 10^9 cells/Liter
Standard Deviation 0.5500
|
0.190 10^9 cells/Liter
Standard Deviation 0.5981
|
0.328 10^9 cells/Liter
Standard Deviation 1.5779
|
-0.273 10^9 cells/Liter
Standard Deviation 0.6049
|
-0.128 10^9 cells/Liter
Standard Deviation 1.0189
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.188 10^9 cells/Liter
Standard Deviation 0.3853
|
0.207 10^9 cells/Liter
Standard Deviation 0.3747
|
-0.107 10^9 cells/Liter
Standard Deviation 0.8863
|
-0.153 10^9 cells/Liter
Standard Deviation 1.0017
|
-0.209 10^9 cells/Liter
Standard Deviation 1.0416
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.177 10^9 cells/Liter
Standard Deviation 0.4173
|
0.135 10^9 cells/Liter
Standard Deviation 0.3031
|
-0.030 10^9 cells/Liter
Standard Deviation 1.1214
|
-0.533 10^9 cells/Liter
Standard Deviation 0.6285
|
-0.114 10^9 cells/Liter
Standard Deviation 1.1418
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.038 10^9 cells/Liter
Standard Deviation 0.2525
|
0.097 10^9 cells/Liter
Standard Deviation 0.3894
|
-0.132 10^9 cells/Liter
Standard Deviation 0.8619
|
-0.746 10^9 cells/Liter
Standard Deviation 1.2632
|
-0.141 10^9 cells/Liter
Standard Deviation 1.0976
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.028 10^9 cells/Liter
Standard Deviation 0.1317
|
0.240 10^9 cells/Liter
Standard Deviation 0.3099
|
0.012 10^9 cells/Liter
Standard Deviation 0.8357
|
-0.791 10^9 cells/Liter
Standard Deviation 1.1634
|
-0.008 10^9 cells/Liter
Standard Deviation 1.3122
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.328 10^9 cells/Liter
Standard Deviation 0.3414
|
0.373 10^9 cells/Liter
Standard Deviation 0.3690
|
-0.042 10^9 cells/Liter
Standard Deviation 0.7593
|
-0.831 10^9 cells/Liter
Standard Deviation 1.1224
|
-0.083 10^9 cells/Liter
Standard Deviation 1.1305
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.222 10^9 cells/Liter
Standard Deviation 0.4540
|
-0.007 10^9 cells/Liter
Standard Deviation 0.4620
|
-0.011 10^9 cells/Liter
Standard Deviation 0.9244
|
-0.598 10^9 cells/Liter
Standard Deviation 0.9450
|
-0.026 10^9 cells/Liter
Standard Deviation 1.1249
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.048 10^9 cells/Liter
Standard Deviation 0.3746
|
0.035 10^9 cells/Liter
Standard Deviation 0.7028
|
-0.072 10^9 cells/Liter
Standard Deviation 0.9007
|
-0.673 10^9 cells/Liter
Standard Deviation 1.2453
|
0.049 10^9 cells/Liter
Standard Deviation 1.1598
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.292 10^9 cells/Liter
Standard Deviation 0.5710
|
0.017 10^9 cells/Liter
Standard Deviation 0.5775
|
0.075 10^9 cells/Liter
Standard Deviation 0.9796
|
-0.497 10^9 cells/Liter
Standard Deviation 1.0625
|
0.255 10^9 cells/Liter
Standard Deviation 1.1764
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Neutrophils, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.490 10^9 cells/Liter
Standard Deviation 0.3072
|
0.555 10^9 cells/Liter
Standard Deviation 1.9413
|
-0.024 10^9 cells/Liter
Standard Deviation 0.7404
|
-0.509 10^9 cells/Liter
Standard Deviation 1.3465
|
0.235 10^9 cells/Liter
Standard Deviation 1.3115
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 2, predose, n=6,5,25,7,14
|
—
|
—
|
—
|
-0.7 10^9 cells/Liter
Standard Deviation 18.78
|
9.8 10^9 cells/Liter
Standard Deviation 6.94
|
5.4 10^9 cells/Liter
Standard Deviation 13.46
|
17.9 10^9 cells/Liter
Standard Deviation 18.89
|
1.3 10^9 cells/Liter
Standard Deviation 20.45
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 4, predose, n=6,5,25,7,14
|
—
|
—
|
—
|
2.5 10^9 cells/Liter
Standard Deviation 12.76
|
-11.2 10^9 cells/Liter
Standard Deviation 8.23
|
2.5 10^9 cells/Liter
Standard Deviation 16.28
|
17.6 10^9 cells/Liter
Standard Deviation 31.86
|
-3.6 10^9 cells/Liter
Standard Deviation 21.81
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
11.2 10^9 cells/Liter
Standard Deviation 20.61
|
10.3 10^9 cells/Liter
Standard Deviation 14.73
|
3.4 10^9 cells/Liter
Standard Deviation 18.67
|
17.1 10^9 cells/Liter
Standard Deviation 13.28
|
3.3 10^9 cells/Liter
Standard Deviation 25.28
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 8 predose, n=6,5,25,7,14
|
—
|
—
|
—
|
0.8 10^9 cells/Liter
Standard Deviation 8.82
|
4.4 10^9 cells/Liter
Standard Deviation 13.87
|
8.6 10^9 cells/Liter
Standard Deviation 19.14
|
16.7 10^9 cells/Liter
Standard Deviation 21.66
|
0.4 10^9 cells/Liter
Standard Deviation 31.14
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.7 10^9 cells/Liter
Standard Deviation 16.38
|
14.7 10^9 cells/Liter
Standard Deviation 11.34
|
8.0 10^9 cells/Liter
Standard Deviation 30.98
|
14.3 10^9 cells/Liter
Standard Deviation 12.38
|
4.8 10^9 cells/Liter
Standard Deviation 31.48
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
4.5 10^9 cells/Liter
Standard Deviation 27.40
|
9.8 10^9 cells/Liter
Standard Deviation 19.02
|
3.6 10^9 cells/Liter
Standard Deviation 34.68
|
6.1 10^9 cells/Liter
Standard Deviation 15.00
|
2.9 10^9 cells/Liter
Standard Deviation 28.62
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
5.3 10^9 cells/Liter
Standard Deviation 23.52
|
-6.2 10^9 cells/Liter
Standard Deviation 19.30
|
8.3 10^9 cells/Liter
Standard Deviation 25.49
|
7.8 10^9 cells/Liter
Standard Deviation 19.74
|
-2.9 10^9 cells/Liter
Standard Deviation 31.90
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-3.0 10^9 cells/Liter
Standard Deviation 13.73
|
-2.8 10^9 cells/Liter
Standard Deviation 13.70
|
1.3 10^9 cells/Liter
Standard Deviation 21.79
|
-2.2 10^9 cells/Liter
Standard Deviation 17.99
|
-1.1 10^9 cells/Liter
Standard Deviation 34.32
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-4.3 10^9 cells/Liter
Standard Deviation 9.93
|
-3.3 10^9 cells/Liter
Standard Deviation 20.74
|
1.0 10^9 cells/Liter
Standard Deviation 23.54
|
-17.3 10^9 cells/Liter
Standard Deviation 33.99
|
-5.4 10^9 cells/Liter
Standard Deviation 25.19
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Platelets, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-8.7 10^9 cells/Liter
Standard Deviation 10.75
|
-11.8 10^9 cells/Liter
Standard Deviation 20.02
|
-3.9 10^9 cells/Liter
Standard Deviation 21.61
|
-4.0 10^9 cells/Liter
Standard Deviation 28.3
|
-5.3 10^9 cells/Liter
Standard Deviation 39.09
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.003 10^9 cells/Liter
Standard Deviation 0.0103
|
0.000 10^9 cells/Liter
Standard Deviation 0.0110
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0111
|
0.001 10^9 cells/Liter
Standard Deviation 0.0069
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0108
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.002 10^9 cells/Liter
Standard Deviation 0.0117
|
0.005 10^9 cells/Liter
Standard Deviation 0.0217
|
-0.001 10^9 cells/Liter
Standard Deviation 0.0108
|
0.001 10^9 cells/Liter
Standard Deviation 0.0107
|
-0.002 10^9 cells/Liter
Standard Deviation 0.0119
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.002 10^9 cells/Liter
Standard Deviation 0.0075
|
0.003 10^9 cells/Liter
Standard Deviation 0.0151
|
0.001 10^9 cells/Liter
Standard Deviation 0.0124
|
0.009 10^9 cells/Liter
Standard Deviation 0.0135
|
-0.002 10^9 cells/Liter
Standard Deviation 0.0105
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.005 10^9 cells/Liter
Standard Deviation 0.0138
|
0.012 10^9 cells/Liter
Standard Deviation 0.0214
|
0.004 10^9 cells/Liter
Standard Deviation 0.0147
|
0.014 10^9 cells/Liter
Standard Deviation 0.0098
|
-0.002 10^9 cells/Liter
Standard Deviation 0.0105
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.005 10^9 cells/Liter
Standard Deviation 0.0055
|
0.013 10^9 cells/Liter
Standard Deviation 0.0163
|
0.010 10^9 cells/Liter
Standard Deviation 0.0108
|
0.011 10^9 cells/Liter
Standard Deviation 0.0121
|
0.001 10^9 cells/Liter
Standard Deviation 0.0123
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.002 10^9 cells/Liter
Standard Deviation 0.0075
|
0.017 10^9 cells/Liter
Standard Deviation 0.0163
|
0.008 10^9 cells/Liter
Standard Deviation 0.0121
|
0.010 10^9 cells/Liter
Standard Deviation 0.0082
|
-0.001 10^9 cells/Liter
Standard Deviation 0.0100
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.003 10^9 cells/Liter
Standard Deviation 0.0052
|
0.002 10^9 cells/Liter
Standard Deviation 0.0214
|
0.007 10^9 cells/Liter
Standard Deviation 0.0140
|
0.017 10^9 cells/Liter
Standard Deviation 0.0082
|
-0.003 10^9 cells/Liter
Standard Deviation 0.0114
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.002 10^9 cells/Liter
Standard Deviation 0.0075
|
0.010 10^9 cells/Liter
Standard Deviation 0.0190
|
0.007 10^9 cells/Liter
Standard Deviation 0.0137
|
0.005 10^9 cells/Liter
Standard Deviation 0.0138
|
-0.001 10^9 cells/Liter
Standard Deviation 0.0103
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.002 10^9 cells/Liter
Standard Deviation 0.0075
|
0.010 10^9 cells/Liter
Standard Deviation 0.0228
|
0.004 10^9 cells/Liter
Standard Deviation 0.0110
|
0.007 10^9 cells/Liter
Standard Deviation 0.0121
|
-0.004 10^9 cells/Liter
Standard Deviation 0.0165
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Basophils, FU(Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.007 10^9 cells/Liter
Standard Deviation 0.0103
|
0.003 10^9 cells/Liter
Standard Deviation 0.0137
|
-0.003 10^9 cells/Liter
Standard Deviation 0.0124
|
-0.001 10^9 cells/Liter
Standard Deviation 0.0069
|
-0.006 10^9 cells/Liter
Standard Deviation 0.0150
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.015 10^9 cells/Liter
Standard Deviation 0.0176
|
0.032 10^9 cells/Liter
Standard Deviation 0.0147
|
0.006 10^9 cells/Liter
Standard Deviation 0.0728
|
0.050 10^9 cells/Liter
Standard Deviation 0.0663
|
-0.001 10^9 cells/Liter
Standard Deviation 0.0438
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.015 10^9 cells/Liter
Standard Deviation 0.0536
|
0.013 10^9 cells/Liter
Standard Deviation 0.0455
|
0.012 10^9 cells/Liter
Standard Deviation 0.0867
|
0.043 10^9 cells/Liter
Standard Deviation 0.0605
|
-0.006 10^9 cells/Liter
Standard Deviation 0.0520
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.043 10^9 cells/Liter
Standard Deviation 0.0665
|
0.007 10^9 cells/Liter
Standard Deviation 0.0528
|
0.000 10^9 cells/Liter
Standard Deviation 0.0876
|
0.034 10^9 cells/Liter
Standard Deviation 0.0832
|
0.000 10^9 cells/Liter
Standard Deviation 0.0411
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.027 10^9 cells/Liter
Standard Deviation 0.0516
|
0.030 10^9 cells/Liter
Standard Deviation 0.0529
|
-0.005 10^9 cells/Liter
Standard Deviation 0.0838
|
0.024 10^9 cells/Liter
Standard Deviation 0.0683
|
-0.007 10^9 cells/Liter
Standard Deviation 0.0395
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.028 10^9 cells/Liter
Standard Deviation 0.0426
|
0.053 10^9 cells/Liter
Standard Deviation 0.0539
|
0.025 10^9 cells/Liter
Standard Deviation 0.1057
|
0.026 10^9 cells/Liter
Standard Deviation 0.0824
|
-0.012 10^9 cells/Liter
Standard Deviation 0.0437
|
—
|
|
Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.
Eosinophils, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.008 10^9 cells/Liter
Standard Deviation 0.0768
|
0.067 10^9 cells/Liter
Standard Deviation 0.0472
|
0.021 10^9 cells/Liter
Standard Deviation 0.1075
|
0.033 10^9 cells/Liter
Standard Deviation 0.0862
|
-0.012 10^9 cells/Liter
Standard Deviation 0.0519
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.197 10^12 cells/Liter
Standard Deviation 0.3267
|
0.230 10^12 cells/Liter
Standard Deviation 0.0994
|
0.088 10^12 cells/Liter
Standard Deviation 0.2160
|
0.323 10^12 cells/Liter
Standard Deviation 0.1614
|
0.146 10^12 cells/Liter
Standard Deviation 0.1480
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.035 10^12 cells/Liter
Standard Deviation 0.3056
|
0.272 10^12 cells/Liter
Standard Deviation 0.1685
|
0.088 10^12 cells/Liter
Standard Deviation 0.2352
|
0.327 10^12 cells/Liter
Standard Deviation 0.1940
|
0.115 10^12 cells/Liter
Standard Deviation 0.1816
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.082 10^12 cells/Liter
Standard Deviation 0.3415
|
0.293 10^12 cells/Liter
Standard Deviation 0.2238
|
0.179 10^12 cells/Liter
Standard Deviation 0.1861
|
0.306 10^12 cells/Liter
Standard Deviation 0.1334
|
0.206 10^12 cells/Liter
Standard Deviation 0.1637
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.078 10^12 cells/Liter
Standard Deviation 0.2423
|
0.387 10^12 cells/Liter
Standard Deviation 0.1643
|
0.139 10^12 cells/Liter
Standard Deviation 0.2004
|
0.296 10^12 cells/Liter
Standard Deviation 0.1049
|
0.179 10^12 cells/Liter
Standard Deviation 0.1372
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.135 10^12 cells/Liter
Standard Deviation 0.2601
|
0.200 10^12 cells/Liter
Standard Deviation 0.1411
|
0.128 10^12 cells/Liter
Standard Deviation 0.2539
|
0.440 10^12 cells/Liter
Standard Deviation 0.1458
|
0.131 10^12 cells/Liter
Standard Deviation 0.2100
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.193 10^12 cells/Liter
Standard Deviation 0.2322
|
0.112 10^12 cells/Liter
Standard Deviation 0.1057
|
0.086 10^12 cells/Liter
Standard Deviation 0.2099
|
0.544 10^12 cells/Liter
Standard Deviation 0.1318
|
0.091 10^12 cells/Liter
Standard Deviation 0.1589
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.017 10^12 cells/Liter
Standard Deviation 0.2243
|
0.037 10^12 cells/Liter
Standard Deviation 0.1394
|
0.031 10^12 cells/Liter
Standard Deviation 0.2429
|
0.385 10^12 cells/Liter
Standard Deviation 0.2288
|
0.005 10^12 cells/Liter
Standard Deviation 0.1931
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.002 10^12 cells/Liter
Standard Deviation 0.2416
|
0.177 10^12 cells/Liter
Standard Deviation 0.2253
|
0.109 10^12 cells/Liter
Standard Deviation 0.2116
|
0.323 10^12 cells/Liter
Standard Deviation 0.2219
|
0.182 10^12 cells/Liter
Standard Deviation 0.2198
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.042 10^12 cells/Liter
Standard Deviation 0.1597
|
0.215 10^12 cells/Liter
Standard Deviation 0.2095
|
0.068 10^12 cells/Liter
Standard Deviation 0.2039
|
0.327 10^12 cells/Liter
Standard Deviation 0.1159
|
0.156 10^12 cells/Liter
Standard Deviation 0.1938
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes
FU (Day 28),n=6,6,25,7,14
|
—
|
—
|
—
|
-0.187 10^12 cells/Liter
Standard Deviation 0.1632
|
-0.123 10^12 cells/Liter
Standard Deviation 0.1835
|
-0.093 10^12 cells/Liter
Standard Deviation 0.2015
|
0.050 10^12 cells/Liter
Standard Deviation 0.2484
|
-0.081 10^12 cells/Liter
Standard Deviation 0.2517
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.20 Femtoliter
Standard Deviation 0.559
|
-0.63 Femtoliter
Standard Deviation 0.989
|
-0.27 Femtoliter
Standard Deviation 1.223
|
-1.13 Femtoliter
Standard Deviation 1.280
|
-0.16 Femtoliter
Standard Deviation 1.126
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.50 Femtoliter
Standard Deviation 0.777
|
-1.05 Femtoliter
Standard Deviation 1.009
|
-0.18 Femtoliter
Standard Deviation 1.321
|
-0.19 Femtoliter
Standard Deviation 1.227
|
0.17 Femtoliter
Standard Deviation 0.675
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.25 Femtoliter
Standard Deviation 0.683
|
0.10 Femtoliter
Standard Deviation 1.368
|
-0.02 Femtoliter
Standard Deviation 1.422
|
-1.30 Femtoliter
Standard Deviation 1.390
|
0.62 Femtoliter
Standard Deviation 1.188
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.03 Femtoliter
Standard Deviation 0.308
|
-0.60 Femtoliter
Standard Deviation 1.226
|
-0.53 Femtoliter
Standard Deviation 1.390
|
-0.67 Femtoliter
Standard Deviation 1.566
|
0.79 Femtoliter
Standard Deviation 1.299
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.02 Femtoliter
Standard Deviation 0.534
|
-0.73 Femtoliter
Standard Deviation 1.025
|
-0.70 Femtoliter
Standard Deviation 1.635
|
-0.90 Femtoliter
Standard Deviation 0.933
|
0.21 Femtoliter
Standard Deviation 1.278
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.33 Femtoliter
Standard Deviation 0.838
|
-0.55 Femtoliter
Standard Deviation 1.017
|
-0.34 Femtoliter
Standard Deviation 0.908
|
-0.99 Femtoliter
Standard Deviation 0.747
|
0.16 Femtoliter
Standard Deviation 1.161
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-0.73 Femtoliter
Standard Deviation 0.864
|
0.72 Femtoliter
Standard Deviation 0.995
|
-0.86 Femtoliter
Standard Deviation 1.693
|
-1.92 Femtoliter
Standard Deviation 1.059
|
0.26 Femtoliter
Standard Deviation 1.585
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.52 Femtoliter
Standard Deviation 0.560
|
-0.40 Femtoliter
Standard Deviation 1.322
|
-0.67 Femtoliter
Standard Deviation 1.209
|
-1.30 Femtoliter
Standard Deviation 0.629
|
0.01 Femtoliter
Standard Deviation 1.210
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.55 Femtoliter
Standard Deviation 0.409
|
-0.25 Femtoliter
Standard Deviation 1.122
|
-0.53 Femtoliter
Standard Deviation 1.361
|
-0.50 Femtoliter
Standard Deviation 0.738
|
0.14 Femtoliter
Standard Deviation 1.329
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV
FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.00 Femtoliter
Standard Deviation 0.678
|
0.63 Femtoliter
Standard Deviation 0.459
|
-0.65 Femtoliter
Standard Deviation 1.447
|
-1.19 Femtoliter
Standard Deviation 0.832
|
0.61 Femtoliter
Standard Deviation 1.215
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocyte MCH. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.10 Picograms
Standard Deviation 0.443
|
-0.35 Picograms
Standard Deviation 0.217
|
-0.08 Picograms
Standard Deviation 0.578
|
-0.46 Picograms
Standard Deviation 0.670
|
-0.14 Picograms
Standard Deviation 0.759
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.32 Picograms
Standard Deviation 0.306
|
-0.03 Picograms
Standard Deviation 0.367
|
0.06 Picograms
Standard Deviation 0.607
|
-0.40 Picograms
Standard Deviation 0.408
|
0.09 Picograms
Standard Deviation 0.684
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.43 Picograms
Standard Deviation 0.413
|
-0.78 Picograms
Standard Deviation 0.172
|
0.06 Picograms
Standard Deviation 0.788
|
-0.30 Picograms
Standard Deviation 0.606
|
-0.06 Picograms
Standard Deviation 0.677
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.23 Picograms
Standard Deviation 0.602
|
-0.55 Picograms
Standard Deviation 0.226
|
0.08 Picograms
Standard Deviation 0.785
|
-0.43 Picograms
Standard Deviation 0.577
|
0.21 Picograms
Standard Deviation 0.673
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.22 Picograms
Standard Deviation 0.571
|
-0.67 Picograms
Standard Deviation 0.339
|
-0.08 Picograms
Standard Deviation 0.573
|
-0.26 Picograms
Standard Deviation 0.544
|
0.01 Picograms
Standard Deviation 0.617
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.00 Picograms
Standard Deviation 0.522
|
-0.68 Picograms
Standard Deviation 0.248
|
0.00 Picograms
Standard Deviation 0.450
|
-0.10 Picograms
Standard Deviation 0.742
|
-0.06 Picograms
Standard Deviation 0.557
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.00 Picograms
Standard Deviation 0.310
|
-0.72 Picograms
Standard Deviation 0.264
|
-0.02 Picograms
Standard Deviation 0.724
|
-0.57 Picograms
Standard Deviation 0.728
|
-0.04 Picograms
Standard Deviation 0.637
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.08 Picograms
Standard Deviation 0.504
|
-0.68 Picograms
Standard Deviation 0.293
|
-0.12 Picograms
Standard Deviation 0.598
|
-0.17 Picograms
Standard Deviation 0.698
|
-0.15 Picograms
Standard Deviation 0.557
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.25 Picograms
Standard Deviation 0.647
|
-0.87 Picograms
Standard Deviation 0.216
|
-0.20 Picograms
Standard Deviation 0.520
|
-0.65 Picograms
Standard Deviation 0.740
|
0.00 Picograms
Standard Deviation 0.477
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)
FU, (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.03 Picograms
Standard Deviation 0.427
|
-0.60 Picograms
Standard Deviation 0.237
|
-0.04 Picograms
Standard Deviation 0.644
|
-0.36 Picograms
Standard Deviation 0.412
|
0.01 Picograms
Standard Deviation 0.637
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.0102 Percentage of red blood cells in blood
Standard Deviation 0.02300
|
0.0140 Percentage of red blood cells in blood
Standard Deviation 0.01425
|
0.0096 Percentage of red blood cells in blood
Standard Deviation 0.01995
|
0.0314 Percentage of red blood cells in blood
Standard Deviation 0.01122
|
0.0108 Percentage of red blood cells in blood
Standard Deviation 0.01712
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.0133 Percentage of red blood cells in blood
Standard Deviation 0.02270
|
0.0043 Percentage of red blood cells in blood
Standard Deviation 0.01154
|
0.0066 Percentage of red blood cells in blood
Standard Deviation 0.01855
|
0.0453 Percentage of red blood cells in blood
Standard Deviation 0.01067
|
0.0085 Percentage of red blood cells in blood
Standard Deviation 0.01459
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.0148 Percentage of red blood cells in blood
Standard Deviation 0.03205
|
0.0202 Percentage of red blood cells in blood
Standard Deviation 0.01304
|
0.0075 Percentage of red blood cells in blood
Standard Deviation 0.01857
|
0.0206 Percentage of red blood cells in blood
Standard Deviation 0.01397
|
0.0155 Percentage of red blood cells in blood
Standard Deviation 0.01108
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.0025 Percentage of red blood cells in blood
Standard Deviation 0.02788
|
0.0203 Percentage of red blood cells in blood
Standard Deviation 0.01250
|
0.0049 Percentage of red blood cells in blood
Standard Deviation 0.01827
|
0.0241 Percentage of red blood cells in blood
Standard Deviation 0.01378
|
0.0137 Percentage of red blood cells in blood
Standard Deviation 0.01431
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.0063 Percentage of red blood cells in blood
Standard Deviation 0.03144
|
0.0217 Percentage of red blood cells in blood
Standard Deviation 0.01697
|
0.0119 Percentage of red blood cells in blood
Standard Deviation 0.02108
|
0.0216 Percentage of red blood cells in blood
Standard Deviation 0.00872
|
0.0191 Percentage of red blood cells in blood
Standard Deviation 0.01466
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.0047 Percentage of red blood cells in blood
Standard Deviation 0.02439
|
0.0302 Percentage of red blood cells in blood
Standard Deviation 0.01396
|
0.0102 Percentage of red blood cells in blood
Standard Deviation 0.01872
|
0.0203 Percentage of red blood cells in blood
Standard Deviation 0.00739
|
0.0159 Percentage of red blood cells in blood
Standard Deviation 0.01201
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-0.0027 Percentage of red blood cells in blood
Standard Deviation 0.02276
|
0.0070 Percentage of red blood cells in blood
Standard Deviation 0.01053
|
-0.0014 Percentage of red blood cells in blood
Standard Deviation 0.02132
|
0.0227 Percentage of red blood cells in blood
Standard Deviation 0.01825
|
0.0019 Percentage of red blood cells in blood
Standard Deviation 0.01499
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.0003 Percentage of red blood cells in blood
Standard Deviation 0.01419
|
0.0170 Percentage of red blood cells in blood
Standard Deviation 0.01665
|
0.0032 Percentage of red blood cells in blood
Standard Deviation 0.01808
|
0.0255 Percentage of red blood cells in blood
Standard Deviation 0.01086
|
0.0145 Percentage of red blood cells in blood
Standard Deviation 0.01594
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.0018 Percentage of red blood cells in blood
Standard Deviation 0.01969
|
0.0133 Percentage of red blood cells in blood
Standard Deviation 0.01375
|
0.0060 Percentage of red blood cells in blood
Standard Deviation 0.01664
|
0.0212 Percentage of red blood cells in blood
Standard Deviation 0.01734
|
0.0157 Percentage of red blood cells in blood
Standard Deviation 0.01601
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hematocrit
FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.0158 Percentage of red blood cells in blood
Standard Deviation 0.01587
|
-0.0070 Percentage of red blood cells in blood
Standard Deviation 0.01628
|
-0.0110 Percentage of red blood cells in blood
Standard Deviation 0.01675
|
-0.0013 Percentage of red blood cells in blood
Standard Deviation 0.01739
|
-0.0046 Percentage of red blood cells in blood
Standard Deviation 0.02040
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.00093 10^12 cells per liter
Standard Deviation 0.001204
|
-0.00103 10^12 cells per liter
Standard Deviation 0.001214
|
0.00088 10^12 cells per liter
Standard Deviation 0.001818
|
-0.00037 10^12 cells per liter
Standard Deviation 0.001190
|
0.00117 10^12 cells per liter
Standard Deviation 0.001333
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.00215 10^12 cells per liter
Standard Deviation 0.001099
|
-0.00032 10^12 cells per liter
Standard Deviation 0.001440
|
0.00131 10^12 cells per liter
Standard Deviation 0.002263
|
0.00124 10^12 cells per liter
Standard Deviation 0.001996
|
0.00157 10^12 cells per liter
Standard Deviation 0.001778
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.00232 10^12 cells per liter
Standard Deviation 0.000999
|
0.00138 10^12 cells per liter
Standard Deviation 0.001118
|
0.00125 10^12 cells per liter
Standard Deviation 0.002761
|
0.00106 10^12 cells per liter
Standard Deviation 0.002192
|
0.00208 10^12 cells per liter
Standard Deviation 0.001785
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.00173 10^12 cells per liter
Standard Deviation 0.001143
|
0.00213 10^12 cells per liter
Standard Deviation 0.000894
|
0.00154 10^12 cells per liter
Standard Deviation 0.002999
|
0.00031 10^12 cells per liter
Standard Deviation 0.001780
|
0.00243 10^12 cells per liter
Standard Deviation 0.002265
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.00203 10^12 cells per liter
Standard Deviation 0.000804
|
0.00255 10^12 cells per liter
Standard Deviation 0.001450
|
0.00153 10^12 cells per liter
Standard Deviation 0.002881
|
-0.00023 10^12 cells per liter
Standard Deviation 0.001186
|
0.00154 10^12 cells per liter
Standard Deviation 0.002233
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.00220 10^12 cells per liter
Standard Deviation 0.001075
|
0.00313 10^12 cells per liter
Standard Deviation 0.001468
|
0.00205 10^12 cells per liter
Standard Deviation 0.002889
|
0.00007 10^12 cells per liter
Standard Deviation 0.001643
|
0.00161 10^12 cells per liter
Standard Deviation 0.002094
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.00287 10^12 cells per liter
Standard Deviation 0.001810
|
0.00318 10^12 cells per liter
Standard Deviation 0.000842
|
0.00212 10^12 cells per liter
Standard Deviation 0.002924
|
-0.00015 10^12 cells per liter
Standard Deviation 0.001621
|
0.00171 10^12 cells per liter
Standard Deviation 0.002176
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.00270 10^12 cells per liter
Standard Deviation 0.001788
|
0.00295 10^12 cells per liter
Standard Deviation 0.001524
|
0.00205 10^12 cells per liter
Standard Deviation 0.003168
|
0.00063 10^12 cells per liter
Standard Deviation 0.001429
|
0.00184 10^12 cells per liter
Standard Deviation 0.003189
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.00222 10^12 cells per liter
Standard Deviation 0.001766
|
0.00163 10^12 cells per liter
Standard Deviation 0.001780
|
0.00195 10^12 cells per liter
Standard Deviation 0.003251
|
0.00013 10^12 cells per liter
Standard Deviation 0.001680
|
0.00111 10^12 cells per liter
Standard Deviation 0.002838
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes
FU, (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.00177 10^12 cells per liter
Standard Deviation 0.001581
|
0.00212 10^12 cells per liter
Standard Deviation 0.002369
|
0.00095 10^12 cells per liter
Standard Deviation 0.003073
|
-0.00084 10^12 cells per liter
Standard Deviation 0.003085
|
0.00104 10^12 cells per liter
Standard Deviation 0.002853
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.3 Grams per liter
Standard Deviation 6.28
|
4.3 Grams per liter
Standard Deviation 4.13
|
3.4 Grams per liter
Standard Deviation 7.18
|
10.6 Grams per liter
Standard Deviation 3.31
|
3.4 Grams per liter
Standard Deviation 5.73
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.8 Grams per liter
Standard Deviation 5.49
|
3.2 Grams per liter
Standard Deviation 2.48
|
2.8 Grams per liter
Standard Deviation 6.28
|
13.9 Grams per liter
Standard Deviation 3.02
|
3.1 Grams per liter
Standard Deviation 4.71
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.5 Grams per liter
Standard Deviation 8.57
|
2.8 Grams per liter
Standard Deviation 3.19
|
3.0 Grams per liter
Standard Deviation 5.91
|
7.7 Grams per liter
Standard Deviation 3.77
|
3.9 Grams per liter
Standard Deviation 3.87
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.3 Grams per liter
Standard Deviation 6.95
|
5.3 Grams per liter
Standard Deviation 5.89
|
3.1 Grams per liter
Standard Deviation 5.93
|
7.3 Grams per liter
Standard Deviation 4.31
|
4.2 Grams per liter
Standard Deviation 5.91
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1.2 Grams per liter
Standard Deviation 8.45
|
5.5 Grams per liter
Standard Deviation 6.22
|
4.9 Grams per liter
Standard Deviation 6.56
|
7.7 Grams per liter
Standard Deviation 3.50
|
6.3 Grams per liter
Standard Deviation 5.80
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
2.3 Grams per liter
Standard Deviation 6.62
|
8.0 Grams per liter
Standard Deviation 5.83
|
4.1 Grams per liter
Standard Deviation 5.70
|
8.1 Grams per liter
Standard Deviation 3.08
|
4.9 Grams per liter
Standard Deviation 4.10
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.3 Grams per liter
Standard Deviation 5.20
|
-2.5 Grams per liter
Standard Deviation 4.23
|
0.9 Grams per liter
Standard Deviation 7.16
|
8.3 Grams per liter
Standard Deviation 3.33
|
0.2 Grams per liter
Standard Deviation 6.15
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.2 Grams per liter
Standard Deviation 4.92
|
1.8 Grams per liter
Standard Deviation 7.39
|
2.8 Grams per liter
Standard Deviation 6.37
|
8.8 Grams per liter
Standard Deviation 4.58
|
4.5 Grams per liter
Standard Deviation 6.42
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.2 Grams per liter
Standard Deviation 3.13
|
2.2 Grams per liter
Standard Deviation 5.98
|
1.1 Grams per liter
Standard Deviation 6.52
|
6.5 Grams per liter
Standard Deviation 2.88
|
4.7 Grams per liter
Standard Deviation 5.09
|
—
|
|
Part 2: Change From Baseline in Hematology Parameter: Hb
FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-5.3 Grams per liter
Standard Deviation 4.18
|
-6.5 Grams per liter
Standard Deviation 5.82
|
-2.9 Grams per liter
Standard Deviation 5.51
|
-0.3 Grams per liter
Standard Deviation 7.54
|
-2.6 Grams per liter
Standard Deviation 7.42
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameter: ALT, AST,ALP. Day -2was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
2.0 International units per liter
Standard Deviation 6.67
|
2.5 International units per liter
Standard Deviation 5.89
|
2.8 International units per liter
Standard Deviation 5.75
|
0.6 International units per liter
Standard Deviation 6.55
|
0.7 International units per liter
Standard Deviation 4.70
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
1.5 International units per liter
Standard Deviation 5.75
|
-6.2 International units per liter
Standard Deviation 5.91
|
-2.4 International units per liter
Standard Deviation 5.41
|
-2.4 International units per liter
Standard Deviation 8.36
|
-1.9 International units per liter
Standard Deviation 7.29
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 2, predose, n=5,6,24,7,14
|
—
|
—
|
—
|
-1.4 International units per liter
Standard Deviation 3.58
|
-1.2 International units per liter
Standard Deviation 2.79
|
-1.5 International units per liter
Standard Deviation 3.51
|
-1.3 International units per liter
Standard Deviation 4.89
|
-2.5 International units per liter
Standard Deviation 3.01
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 4, predose, n=5,6,25,7,14
|
—
|
—
|
—
|
0.6 International units per liter
Standard Deviation 2.88
|
-3.0 International units per liter
Standard Deviation 3.10
|
-1.4 International units per liter
Standard Deviation 4.22
|
-2.4 International units per liter
Standard Deviation 4.24
|
-1.5 International units per liter
Standard Deviation 4.29
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 6, predose, n=5,6,25,7,14
|
—
|
—
|
—
|
0.0 International units per liter
Standard Deviation 4.18
|
-1.3 International units per liter
Standard Deviation 3.88
|
-1.7 International units per liter
Standard Deviation 3.79
|
-3.6 International units per liter
Standard Deviation 2.94
|
-1.9 International units per liter
Standard Deviation 5.40
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 8 predose, n=5,5,25,7,14
|
—
|
—
|
—
|
0.6 International units per liter
Standard Deviation 4.34
|
-6.4 International units per liter
Standard Deviation 4.04
|
-0.8 International units per liter
Standard Deviation 4.64
|
-3.1 International units per liter
Standard Deviation 4.06
|
-1.1 International units per liter
Standard Deviation 6.28
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 10, predose, n=5,6,25,7,14
|
—
|
—
|
—
|
0.0 International units per liter
Standard Deviation 3.24
|
-2.8 International units per liter
Standard Deviation 3.60
|
-1.6 International units per liter
Standard Deviation 4.24
|
-3.6 International units per liter
Standard Deviation 3.15
|
-1.5 International units per liter
Standard Deviation 7.62
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 12, predose, n=5,6,25,7,14
|
—
|
—
|
—
|
0.2 International units per liter
Standard Deviation 4.32
|
-3.3 International units per liter
Standard Deviation 5.09
|
-2.0 International units per liter
Standard Deviation 4.63
|
-4.1 International units per liter
Standard Deviation 4.38
|
-1.6 International units per liter
Standard Deviation 7.53
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 14, predose, n=4,5,23,5,12
|
—
|
—
|
—
|
2.8 International units per liter
Standard Deviation 3.30
|
-5.6 International units per liter
Standard Deviation 6.02
|
-2.0 International units per liter
Standard Deviation 3.42
|
-1.6 International units per liter
Standard Deviation 5.68
|
-2.8 International units per liter
Standard Deviation 7.38
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 14, 48 hours, n=5,6,24,6,14
|
—
|
—
|
—
|
0.8 International units per liter
Standard Deviation 4.44
|
-3.0 International units per liter
Standard Deviation 4.69
|
-1.8 International units per liter
Standard Deviation 3.95
|
-3.5 International units per liter
Standard Deviation 2.88
|
-2.4 International units per liter
Standard Deviation 7.67
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
AST, Day 14, 96 hours, n=5,6,24,6,14
|
—
|
—
|
—
|
2.4 International units per liter
Standard Deviation 4.22
|
-2.8 International units per liter
Standard Deviation 4.45
|
-2.0 International units per liter
Standard Deviation 3.93
|
-2.2 International units per liter
Standard Deviation 6.43
|
-1.2 International units per liter
Standard Deviation 9.22
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
6.0 International units per liter
Standard Deviation 10.35
|
-0.3 International units per liter
Standard Deviation 13.34
|
3.9 International units per liter
Standard Deviation 6.98
|
1.8 International units per liter
Standard Deviation 6.85
|
1.1 International units per liter
Standard Deviation 15.54
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.2 International units per liter
Standard Deviation 6.55
|
-0.2 International units per liter
Standard Deviation 7.86
|
0.9 International units per liter
Standard Deviation 4.95
|
0.3 International units per liter
Standard Deviation 4.07
|
0.9 International units per liter
Standard Deviation 7.45
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.2 International units per liter
Standard Deviation 5.08
|
1.0 International units per liter
Standard Deviation 4.56
|
0.5 International units per liter
Standard Deviation 3.43
|
1.7 International units per liter
Standard Deviation 2.63
|
-0.4 International units per liter
Standard Deviation 3.71
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.0 International units per liter
Standard Deviation 5.44
|
-1.3 International units per liter
Standard Deviation 6.35
|
1.4 International units per liter
Standard Deviation 4.66
|
3.4 International units per liter
Standard Deviation 5.32
|
0.3 International units per liter
Standard Deviation 4.01
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.0 International units per liter
Standard Deviation 7.62
|
-6.4 International units per liter
Standard Deviation 9.66
|
1.8 International units per liter
Standard Deviation 6.22
|
1.7 International units per liter
Standard Deviation 4.68
|
-0.4 International units per liter
Standard Deviation 7.51
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
2.2 International units per liter
Standard Deviation 8.04
|
0.8 International units per liter
Standard Deviation 11.75
|
3.5 International units per liter
Standard Deviation 6.85
|
0.7 International units per liter
Standard Deviation 4.89
|
0.4 International units per liter
Standard Deviation 11.55
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
4.8 International units per liter
Standard Deviation 10.85
|
1.8 International units per liter
Standard Deviation 13.76
|
1.8 International units per liter
Standard Deviation 6.08
|
0.1 International units per liter
Standard Deviation 4.49
|
-0.4 International units per liter
Standard Deviation 14.70
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 14, predose, n=5,5,25,6,14
|
—
|
—
|
—
|
1.4 International units per liter
Standard Deviation 9.26
|
-2.6 International units per liter
Standard Deviation 12.97
|
2.6 International units per liter
Standard Deviation 6.37
|
-1.0 International units per liter
Standard Deviation 4.10
|
-1.2 International units per liter
Standard Deviation 13.45
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
5.8 International units per liter
Standard Deviation 15.54
|
1.7 International units per liter
Standard Deviation 13.69
|
3.7 International units per liter
Standard Deviation 6.19
|
-0.3 International units per liter
Standard Deviation 3.50
|
1.0 International units per liter
Standard Deviation 13.94
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALT, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
2.5 International units per liter
Standard Deviation 5.09
|
7.0 International units per liter
Standard Deviation 20.39
|
4.6 International units per liter
Standard Deviation 9.22
|
-1.3 International units per liter
Standard Deviation 3.30
|
0.3 International units per liter
Standard Deviation 8.41
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.7 International units per liter
Standard Deviation 1.37
|
-3.7 International units per liter
Standard Deviation 4.97
|
-0.9 International units per liter
Standard Deviation 4.66
|
-0.1 International units per liter
Standard Deviation 3.67
|
-2.3 International units per liter
Standard Deviation 5.74
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.7 International units per liter
Standard Deviation 3.67
|
-7.2 International units per liter
Standard Deviation 5.23
|
0.3 International units per liter
Standard Deviation 5.01
|
1.6 International units per liter
Standard Deviation 6.75
|
-2.1 International units per liter
Standard Deviation 4.31
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.3 International units per liter
Standard Deviation 7.28
|
-5.2 International units per liter
Standard Deviation 4.62
|
0.3 International units per liter
Standard Deviation 5.41
|
0.9 International units per liter
Standard Deviation 5.52
|
-0.6 International units per liter
Standard Deviation 4.88
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 8 predose, n=6,5,25,7,14
|
—
|
—
|
—
|
1.0 International units per liter
Standard Deviation 4.52
|
-4.4 International units per liter
Standard Deviation 4.51
|
-0.1 International units per liter
Standard Deviation 5.33
|
-0.4 International units per liter
Standard Deviation 7.41
|
-1.4 International units per liter
Standard Deviation 5.96
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.8 International units per liter
Standard Deviation 4.92
|
-6.2 International units per liter
Standard Deviation 3.19
|
-0.3 International units per liter
Standard Deviation 5.53
|
-1.0 International units per liter
Standard Deviation 8.85
|
-1.2 International units per liter
Standard Deviation 5.94
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.2 International units per liter
Standard Deviation 3.92
|
-5.7 International units per liter
Standard Deviation 3.39
|
0.2 International units per liter
Standard Deviation 5.80
|
-0.1 International units per liter
Standard Deviation 11.44
|
-1.4 International units per liter
Standard Deviation 6.12
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 14, predose, n=5,5,25,6,14
|
—
|
—
|
—
|
-3.6 International units per liter
Standard Deviation 7.13
|
-8.8 International units per liter
Standard Deviation 6.10
|
-2.2 International units per liter
Standard Deviation 4.87
|
0.8 International units per liter
Standard Deviation 3.19
|
-4.2 International units per liter
Standard Deviation 6.17
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-1.3 International units per liter
Standard Deviation 4.93
|
-6.0 International units per liter
Standard Deviation 4.73
|
-1.6 International units per liter
Standard Deviation 5.06
|
1.2 International units per liter
Standard Deviation 5.53
|
-1.5 International units per liter
Standard Deviation 6.02
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP
ALP, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
2.7 International units per liter
Standard Deviation 5.13
|
-6.8 International units per liter
Standard Deviation 6.01
|
-1.8 International units per liter
Standard Deviation 5.67
|
1.2 International units per liter
Standard Deviation 3.31
|
-1.3 International units per liter
Standard Deviation 6.09
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.7 Millimoles per liter
Standard Deviation 2.80
|
-1.3 Millimoles per liter
Standard Deviation 2.07
|
0.2 Millimoles per liter
Standard Deviation 2.31
|
1.1 Millimoles per liter
Standard Deviation 1.57
|
0.4 Millimoles per liter
Standard Deviation 1.95
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1.8 Millimoles per liter
Standard Deviation 1.72
|
-3.3 Millimoles per liter
Standard Deviation 1.97
|
1.0 Millimoles per liter
Standard Deviation 2.23
|
3.1 Millimoles per liter
Standard Deviation 3.08
|
2.1 Millimoles per liter
Standard Deviation 2.09
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.2 Millimoles per liter
Standard Deviation 2.40
|
-4.5 Millimoles per liter
Standard Deviation 1.22
|
1.0 Millimoles per liter
Standard Deviation 2.17
|
0.4 Millimoles per liter
Standard Deviation 1.81
|
1.8 Millimoles per liter
Standard Deviation 1.72
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.7 Millimoles per liter
Standard Deviation 1.86
|
-1.5 Millimoles per liter
Standard Deviation 1.87
|
1.0 Millimoles per liter
Standard Deviation 1.63
|
1.3 Millimoles per liter
Standard Deviation 1.70
|
1.6 Millimoles per liter
Standard Deviation 1.91
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.5 Millimoles per liter
Standard Deviation 2.81
|
-0.2 Millimoles per liter
Standard Deviation 1.72
|
2.4 Millimoles per liter
Standard Deviation 3.29
|
2.0 Millimoles per liter
Standard Deviation 1.63
|
2.4 Millimoles per liter
Standard Deviation 2.24
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.8 Millimoles per liter
Standard Deviation 1.60
|
-0.5 Millimoles per liter
Standard Deviation 1.64
|
1.3 Millimoles per liter
Standard Deviation 2.17
|
3.4 Millimoles per liter
Standard Deviation 2.82
|
1.6 Millimoles per liter
Standard Deviation 1.65
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 14, predose, n=6,6,25,6,12
|
—
|
—
|
—
|
-1.2 Millimoles per liter
Standard Deviation 0.98
|
-1.2 Millimoles per liter
Standard Deviation 1.72
|
0.1 Millimoles per liter
Standard Deviation 1.93
|
1.5 Millimoles per liter
Standard Deviation 1.05
|
1.0 Millimoles per liter
Standard Deviation 1.62
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.2 Millimoles per liter
Standard Deviation 1.47
|
0.8 Millimoles per liter
Standard Deviation 0.98
|
2.2 Millimoles per liter
Standard Deviation 2.30
|
2.5 Millimoles per liter
Standard Deviation 3.56
|
3.0 Millimoles per liter
Standard Deviation 2.11
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-1.2 Millimoles per liter
Standard Deviation 1.72
|
1.0 Millimoles per liter
Standard Deviation 1.67
|
1.7 Millimoles per liter
Standard Deviation 1.55
|
4.3 Millimoles per liter
Standard Deviation 2.16
|
2.3 Millimoles per liter
Standard Deviation 2.05
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Bicarbonate, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.3 Millimoles per liter
Standard Deviation 2.94
|
-1.0 Millimoles per liter
Standard Deviation 0.63
|
0.3 Millimoles per liter
Standard Deviation 2.50
|
2.3 Millimoles per liter
Standard Deviation 2.56
|
0.8 Millimoles per liter
Standard Deviation 1.72
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.005 Millimoles per liter
Standard Deviation 0.0497
|
0.012 Millimoles per liter
Standard Deviation 0.0354
|
0.003 Millimoles per liter
Standard Deviation 0.0701
|
0.104 Millimoles per liter
Standard Deviation 0.0627
|
0.003 Millimoles per liter
Standard Deviation 0.0722
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.022 Millimoles per liter
Standard Deviation 0.0791
|
0.010 Millimoles per liter
Standard Deviation 0.0385
|
0.013 Millimoles per liter
Standard Deviation 0.0580
|
0.117 Millimoles per liter
Standard Deviation 0.0574
|
0.030 Millimoles per liter
Standard Deviation 0.0479
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.028 Millimoles per liter
Standard Deviation 0.1063
|
0.003 Millimoles per liter
Standard Deviation 0.0505
|
-0.020 Millimoles per liter
Standard Deviation 0.0607
|
0.083 Millimoles per liter
Standard Deviation 0.0512
|
0.011 Millimoles per liter
Standard Deviation 0.0578
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.000 Millimoles per liter
Standard Deviation 0.0890
|
0.017 Millimoles per liter
Standard Deviation 0.0408
|
0.014 Millimoles per liter
Standard Deviation 0.0699
|
0.079 Millimoles per liter
Standard Deviation 0.0763
|
0.024 Millimoles per liter
Standard Deviation 0.0628
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.005 Millimoles per liter
Standard Deviation 0.0528
|
0.003 Millimoles per liter
Standard Deviation 0.0378
|
0.006 Millimoles per liter
Standard Deviation 0.0575
|
0.074 Millimoles per liter
Standard Deviation 0.0387
|
0.028 Millimoles per liter
Standard Deviation 0.0641
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.063 Millimoles per liter
Standard Deviation 0.0619
|
-0.010 Millimoles per liter
Standard Deviation 0.0551
|
0.024 Millimoles per liter
Standard Deviation 0.0667
|
0.066 Millimoles per liter
Standard Deviation 0.0608
|
0.025 Millimoles per liter
Standard Deviation 0.0617
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 14, predose, n=6,6,25,6,12
|
—
|
—
|
—
|
-0.063 Millimoles per liter
Standard Deviation 0.0779
|
-0.034 Millimoles per liter
Standard Deviation 0.0404
|
-0.015 Millimoles per liter
Standard Deviation 0.0843
|
0.028 Millimoles per liter
Standard Deviation 0.0512
|
0.008 Millimoles per liter
Standard Deviation 0.0715
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.949620 Millimoles per liter
Standard Deviation 1.5674926
|
-0.483140 Millimoles per liter
Standard Deviation 0.9278887
|
-0.749700 Millimoles per liter
Standard Deviation 1.1904312
|
-0.499800 Millimoles per liter
Standard Deviation 0.8387115
|
-0.556920 Millimoles per liter
Standard Deviation 1.1341178
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.882980 Millimoles per liter
Standard Deviation 1.2603155
|
-1.166200 Millimoles per liter
Standard Deviation 0.9580876
|
-0.411835 Millimoles per liter
Standard Deviation 1.0341231
|
-0.571200 Millimoles per liter
Standard Deviation 0.6208106
|
-0.778260 Millimoles per liter
Standard Deviation 0.9818953
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 14, predose, n=5,5,24,6,13
|
—
|
—
|
—
|
-0.12 Millimoles per liter
Standard Deviation 0.277
|
-0.20 Millimoles per liter
Standard Deviation 0.300
|
-0.06 Millimoles per liter
Standard Deviation 0.388
|
-0.05 Millimoles per liter
Standard Deviation 0.327
|
0.19 Millimoles per liter
Standard Deviation 0.348
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.017 Millimoles per liter
Standard Deviation 0.0592
|
0.012 Millimoles per liter
Standard Deviation 0.0462
|
0.035 Millimoles per liter
Standard Deviation 0.0566
|
0.072 Millimoles per liter
Standard Deviation 0.0806
|
0.033 Millimoles per liter
Standard Deviation 0.0770
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.005 Millimoles per liter
Standard Deviation 0.0459
|
0.027 Millimoles per liter
Standard Deviation 0.0472
|
0.037 Millimoles per liter
Standard Deviation 0.0526
|
0.078 Millimoles per liter
Standard Deviation 0.1042
|
0.046 Millimoles per liter
Standard Deviation 0.0580
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Calcium, FU(Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.042 Millimoles per liter
Standard Deviation 0.0471
|
0.003 Millimoles per liter
Standard Deviation 0.0550
|
-0.018 Millimoles per liter
Standard Deviation 0.0572
|
0.039 Millimoles per liter
Standard Deviation 0.0891
|
0.019 Millimoles per liter
Standard Deviation 0.0827
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.7 Millimoles per liter
Standard Deviation 1.03
|
2.0 Millimoles per liter
Standard Deviation 2.10
|
0.4 Millimoles per liter
Standard Deviation 1.45
|
-0.1 Millimoles per liter
Standard Deviation 1.57
|
1.1 Millimoles per liter
Standard Deviation 1.98
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.7 Millimoles per liter
Standard Deviation 1.63
|
2.3 Millimoles per liter
Standard Deviation 1.63
|
0.1 Millimoles per liter
Standard Deviation 1.72
|
0.0 Millimoles per liter
Standard Deviation 2.45
|
0.9 Millimoles per liter
Standard Deviation 1.90
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.2 Millimoles per liter
Standard Deviation 1.17
|
0.7 Millimoles per liter
Standard Deviation 1.21
|
0.2 Millimoles per liter
Standard Deviation 2.01
|
0.4 Millimoles per liter
Standard Deviation 1.40
|
0.4 Millimoles per liter
Standard Deviation 2.10
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.5 Millimoles per liter
Standard Deviation 1.38
|
1.8 Millimoles per liter
Standard Deviation 1.33
|
-0.2 Millimoles per liter
Standard Deviation 1.67
|
1.3 Millimoles per liter
Standard Deviation 1.70
|
0.6 Millimoles per liter
Standard Deviation 2.14
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
2.0 Millimoles per liter
Standard Deviation 1.41
|
1.7 Millimoles per liter
Standard Deviation 1.03
|
0.0 Millimoles per liter
Standard Deviation 1.99
|
0.7 Millimoles per liter
Standard Deviation 2.43
|
0.7 Millimoles per liter
Standard Deviation 1.77
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.3 Millimoles per liter
Standard Deviation 1.75
|
2.0 Millimoles per liter
Standard Deviation 1.26
|
0.8 Millimoles per liter
Standard Deviation 1.80
|
0.7 Millimoles per liter
Standard Deviation 2.29
|
1.3 Millimoles per liter
Standard Deviation 2.23
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 14, predose, n=6,6,25,6,12
|
—
|
—
|
—
|
1.8 Millimoles per liter
Standard Deviation 2.14
|
2.2 Millimoles per liter
Standard Deviation 1.17
|
0.9 Millimoles per liter
Standard Deviation 2.12
|
0.2 Millimoles per liter
Standard Deviation 1.47
|
1.0 Millimoles per liter
Standard Deviation 2.11
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
3.2 Millimoles per liter
Standard Deviation 1.72
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
1.0 Millimoles per liter
Standard Deviation 1.76
|
1.0 Millimoles per liter
Standard Deviation 2.53
|
1.1 Millimoles per liter
Standard Deviation 2.37
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
1.0 Millimoles per liter
Standard Deviation 0.00
|
2.8 Millimoles per liter
Standard Deviation 1.33
|
0.6 Millimoles per liter
Standard Deviation 1.71
|
-0.5 Millimoles per liter
Standard Deviation 1.87
|
0.5 Millimoles per liter
Standard Deviation 2.21
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Chloride, FU(Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
1.3 Millimoles per liter
Standard Deviation 1.21
|
0.5 Millimoles per liter
Standard Deviation 1.38
|
0.4 Millimoles per liter
Standard Deviation 1.55
|
0.3 Millimoles per liter
Standard Deviation 2.43
|
0.8 Millimoles per liter
Standard Deviation 1.89
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.055 Millimoles per liter
Standard Deviation 0.0596
|
-0.012 Millimoles per liter
Standard Deviation 0.0436
|
-0.004 Millimoles per liter
Standard Deviation 0.0486
|
0.016 Millimoles per liter
Standard Deviation 0.0624
|
-0.006 Millimoles per liter
Standard Deviation 0.0422
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.063 Millimoles per liter
Standard Deviation 0.0472
|
-0.027 Millimoles per liter
Standard Deviation 0.0520
|
0.005 Millimoles per liter
Standard Deviation 0.0415
|
0.027 Millimoles per liter
Standard Deviation 0.0577
|
0.007 Millimoles per liter
Standard Deviation 0.0347
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.053 Millimoles per liter
Standard Deviation 0.0388
|
-0.027 Millimoles per liter
Standard Deviation 0.0589
|
0.019 Millimoles per liter
Standard Deviation 0.0476
|
0.017 Millimoles per liter
Standard Deviation 0.0399
|
0.008 Millimoles per liter
Standard Deviation 0.0556
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.075 Millimoles per liter
Standard Deviation 0.0532
|
0.000 Millimoles per liter
Standard Deviation 0.0420
|
0.002 Millimoles per liter
Standard Deviation 0.0426
|
0.019 Millimoles per liter
Standard Deviation 0.0438
|
0.004 Millimoles per liter
Standard Deviation 0.0420
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.047 Millimoles per liter
Standard Deviation 0.0543
|
-0.003 Millimoles per liter
Standard Deviation 0.0361
|
0.018 Millimoles per liter
Standard Deviation 0.0472
|
0.017 Millimoles per liter
Standard Deviation 0.0390
|
0.000 Millimoles per liter
Standard Deviation 0.0566
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.038 Millimoles per liter
Standard Deviation 0.0585
|
0.013 Millimoles per liter
Standard Deviation 0.0505
|
0.014 Millimoles per liter
Standard Deviation 0.0401
|
0.007 Millimoles per liter
Standard Deviation 0.0446
|
0.004 Millimoles per liter
Standard Deviation 0.0390
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 14, predose, n=5,6,25,6,14
|
—
|
—
|
—
|
0.030 Millimoles per liter
Standard Deviation 0.0495
|
-0.013 Millimoles per liter
Standard Deviation 0.0653
|
0.019 Millimoles per liter
Standard Deviation 0.0473
|
-0.002 Millimoles per liter
Standard Deviation 0.0343
|
-0.001 Millimoles per liter
Standard Deviation 0.0551
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.040 Millimoles per liter
Standard Deviation 0.0555
|
-0.022 Millimoles per liter
Standard Deviation 0.0445
|
0.011 Millimoles per liter
Standard Deviation 0.0355
|
0.020 Millimoles per liter
Standard Deviation 0.0603
|
-0.001 Millimoles per liter
Standard Deviation 0.0363
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.025 Millimoles per liter
Standard Deviation 0.0485
|
-0.007 Millimoles per liter
Standard Deviation 0.0423
|
0.011 Millimoles per liter
Standard Deviation 0.0360
|
0.022 Millimoles per liter
Standard Deviation 0.0331
|
-0.002 Millimoles per liter
Standard Deviation 0.0662
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Magnesium, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.037 Millimoles per liter
Standard Deviation 0.0509
|
-0.027 Millimoles per liter
Standard Deviation 0.0589
|
0.001 Millimoles per liter
Standard Deviation 0.0387
|
-0.003 Millimoles per liter
Standard Deviation 0.0415
|
-0.009 Millimoles per liter
Standard Deviation 0.0469
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.068 Millimoles per liter
Standard Deviation 0.1636
|
0.062 Millimoles per liter
Standard Deviation 0.0760
|
-0.024 Millimoles per liter
Standard Deviation 0.1248
|
0.086 Millimoles per liter
Standard Deviation 0.1585
|
0.035 Millimoles per liter
Standard Deviation 0.2069
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.057 Millimoles per liter
Standard Deviation 0.1091
|
0.017 Millimoles per liter
Standard Deviation 0.1237
|
-0.003 Millimoles per liter
Standard Deviation 0.1382
|
0.057 Millimoles per liter
Standard Deviation 0.1045
|
0.036 Millimoles per liter
Standard Deviation 0.1835
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.100 Millimoles per liter
Standard Deviation 0.1324
|
0.038 Millimoles per liter
Standard Deviation 0.1080
|
-0.014 Millimoles per liter
Standard Deviation 0.1375
|
0.164 Millimoles per liter
Standard Deviation 0.1018
|
0.060 Millimoles per liter
Standard Deviation 0.2119
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.150 Millimoles per liter
Standard Deviation 0.1145
|
0.075 Millimoles per liter
Standard Deviation 0.1140
|
0.021 Millimoles per liter
Standard Deviation 0.1285
|
0.121 Millimoles per liter
Standard Deviation 0.1644
|
0.074 Millimoles per liter
Standard Deviation 0.2112
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.150 Millimoles per liter
Standard Deviation 0.1848
|
0.118 Millimoles per liter
Standard Deviation 0.0937
|
0.061 Millimoles per liter
Standard Deviation 0.1372
|
0.140 Millimoles per liter
Standard Deviation 0.1344
|
0.129 Millimoles per liter
Standard Deviation 0.1626
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.155 Millimoles per liter
Standard Deviation 0.1428
|
0.090 Millimoles per liter
Standard Deviation 0.0827
|
0.085 Millimoles per liter
Standard Deviation 0.1704
|
0.193 Millimoles per liter
Standard Deviation 0.1329
|
0.139 Millimoles per liter
Standard Deviation 0.2000
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.10 Millimoles per liter
Standard Deviation 0.390
|
-0.10 Millimoles per liter
Standard Deviation 0.190
|
0.12 Millimoles per liter
Standard Deviation 0.340
|
0.41 Millimoles per liter
Standard Deviation 0.662
|
0.14 Millimoles per liter
Standard Deviation 0.203
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 14, predose, n=5,6,25,6,14
|
—
|
—
|
—
|
0.212 Millimoles per liter
Standard Deviation 0.1587
|
0.087 Millimoles per liter
Standard Deviation 0.1388
|
0.043 Millimoles per liter
Standard Deviation 0.1363
|
0.170 Millimoles per liter
Standard Deviation 0.1030
|
0.101 Millimoles per liter
Standard Deviation 0.2161
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.208 Millimoles per liter
Standard Deviation 0.1382
|
0.063 Millimoles per liter
Standard Deviation 0.1516
|
0.093 Millimoles per liter
Standard Deviation 0.1517
|
0.052 Millimoles per liter
Standard Deviation 0.1446
|
0.082 Millimoles per liter
Standard Deviation 0.1873
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.178 Millimoles per liter
Standard Deviation 0.1869
|
0.140 Millimoles per liter
Standard Deviation 0.1255
|
0.089 Millimoles per liter
Standard Deviation 0.1510
|
0.085 Millimoles per liter
Standard Deviation 0.1536
|
0.119 Millimoles per liter
Standard Deviation 0.2051
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Phosphate, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.013 Millimoles per liter
Standard Deviation 0.1363
|
-0.020 Millimoles per liter
Standard Deviation 0.1418
|
-0.047 Millimoles per liter
Standard Deviation 0.1837
|
0.010 Millimoles per liter
Standard Deviation 0.1795
|
0.010 Millimoles per liter
Standard Deviation 0.1741
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.28 Millimoles per liter
Standard Deviation 0.279
|
-0.07 Millimoles per liter
Standard Deviation 0.216
|
0.17 Millimoles per liter
Standard Deviation 0.369
|
0.20 Millimoles per liter
Standard Deviation 0.383
|
0.19 Millimoles per liter
Standard Deviation 0.141
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.30 Millimoles per liter
Standard Deviation 0.529
|
0.12 Millimoles per liter
Standard Deviation 0.264
|
0.11 Millimoles per liter
Standard Deviation 0.396
|
0.21 Millimoles per liter
Standard Deviation 0.285
|
0.06 Millimoles per liter
Standard Deviation 0.234
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 8 predose, n=6,5,25,7,14
|
—
|
—
|
—
|
0.23 Millimoles per liter
Standard Deviation 0.216
|
-0.06 Millimoles per liter
Standard Deviation 0.152
|
0.04 Millimoles per liter
Standard Deviation 0.364
|
0.20 Millimoles per liter
Standard Deviation 0.374
|
0.17 Millimoles per liter
Standard Deviation 0.307
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.32 Millimoles per liter
Standard Deviation 0.519
|
-0.08 Millimoles per liter
Standard Deviation 0.194
|
0.06 Millimoles per liter
Standard Deviation 0.406
|
0.21 Millimoles per liter
Standard Deviation 0.358
|
0.09 Millimoles per liter
Standard Deviation 0.138
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.38 Millimoles per liter
Standard Deviation 0.431
|
-0.13 Millimoles per liter
Standard Deviation 0.280
|
0.08 Millimoles per liter
Standard Deviation 0.384
|
0.17 Millimoles per liter
Standard Deviation 0.399
|
0.22 Millimoles per liter
Standard Deviation 0.176
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.27 Millimoles per liter
Standard Deviation 0.509
|
-0.18 Millimoles per liter
Standard Deviation 0.204
|
0.07 Millimoles per liter
Standard Deviation 0.338
|
-0.08 Millimoles per liter
Standard Deviation 0.331
|
0.04 Millimoles per liter
Standard Deviation 0.214
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.07 Millimoles per liter
Standard Deviation 0.333
|
-0.13 Millimoles per liter
Standard Deviation 0.137
|
0.00 Millimoles per liter
Standard Deviation 0.393
|
0.08 Millimoles per liter
Standard Deviation 0.172
|
0.13 Millimoles per liter
Standard Deviation 0.261
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Potassium, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.05 Millimoles per liter
Standard Deviation 0.383
|
-0.08 Millimoles per liter
Standard Deviation 0.160
|
-0.06 Millimoles per liter
Standard Deviation 0.347
|
-0.13 Millimoles per liter
Standard Deviation 0.335
|
0.21 Millimoles per liter
Standard Deviation 0.530
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.2 Millimoles per liter
Standard Deviation 1.47
|
1.2 Millimoles per liter
Standard Deviation 1.47
|
-0.5 Millimoles per liter
Standard Deviation 1.48
|
-1.1 Millimoles per liter
Standard Deviation 1.86
|
0.1 Millimoles per liter
Standard Deviation 2.11
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1.5 Millimoles per liter
Standard Deviation 1.87
|
1.5 Millimoles per liter
Standard Deviation 1.38
|
-0.3 Millimoles per liter
Standard Deviation 1.17
|
0.9 Millimoles per liter
Standard Deviation 1.77
|
0.8 Millimoles per liter
Standard Deviation 1.93
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.3 Millimoles per liter
Standard Deviation 1.21
|
1.2 Millimoles per liter
Standard Deviation 1.17
|
-0.7 Millimoles per liter
Standard Deviation 1.14
|
-0.1 Millimoles per liter
Standard Deviation 1.07
|
0.5 Millimoles per liter
Standard Deviation 1.70
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.5 Millimoles per liter
Standard Deviation 1.38
|
1.8 Millimoles per liter
Standard Deviation 0.75
|
-1.0 Millimoles per liter
Standard Deviation 1.15
|
0.4 Millimoles per liter
Standard Deviation 1.40
|
0.7 Millimoles per liter
Standard Deviation 2.16
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1.5 Millimoles per liter
Standard Deviation 1.22
|
2.8 Millimoles per liter
Standard Deviation 0.98
|
0.3 Millimoles per liter
Standard Deviation 2.10
|
1.0 Millimoles per liter
Standard Deviation 1.63
|
0.9 Millimoles per liter
Standard Deviation 2.07
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1.2 Millimoles per liter
Standard Deviation 0.98
|
1.7 Millimoles per liter
Standard Deviation 1.03
|
0.2 Millimoles per liter
Standard Deviation 1.53
|
0.9 Millimoles per liter
Standard Deviation 1.57
|
1.2 Millimoles per liter
Standard Deviation 1.89
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.5 Millimoles per liter
Standard Deviation 1.52
|
2.2 Millimoles per liter
Standard Deviation 1.17
|
-1.1 Millimoles per liter
Standard Deviation 1.83
|
-0.5 Millimoles per liter
Standard Deviation 0.55
|
0.1 Millimoles per liter
Standard Deviation 2.34
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
3.3 Millimoles per liter
Standard Deviation 1.75
|
1.0 Millimoles per liter
Standard Deviation 0.89
|
0.4 Millimoles per liter
Standard Deviation 1.35
|
0.5 Millimoles per liter
Standard Deviation 0.84
|
1.3 Millimoles per liter
Standard Deviation 2.27
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
1.5 Millimoles per liter
Standard Deviation 1.52
|
2.3 Millimoles per liter
Standard Deviation 0.82
|
0.6 Millimoles per liter
Standard Deviation 1.59
|
0.3 Millimoles per liter
Standard Deviation 1.03
|
1.1 Millimoles per liter
Standard Deviation 2.59
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Sodium, FU(Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
1.8 Millimoles per liter
Standard Deviation 2.48
|
0.8 Millimoles per liter
Standard Deviation 1.72
|
-0.1 Millimoles per liter
Standard Deviation 1.58
|
0.0 Millimoles per liter
Standard Deviation 1.73
|
0.9 Millimoles per liter
Standard Deviation 2.32
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.583100 Millimoles per liter
Standard Deviation 1.7190989
|
-0.383180 Millimoles per liter
Standard Deviation 0.8994549
|
-0.279888 Millimoles per liter
Standard Deviation 1.3039577
|
0.242760 Millimoles per liter
Standard Deviation 0.8615469
|
-0.221340 Millimoles per liter
Standard Deviation 1.0565530
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.982940 Millimoles per liter
Standard Deviation 2.0645229
|
-0.616420 Millimoles per liter
Standard Deviation 0.8994549
|
-0.415834 Millimoles per liter
Standard Deviation 1.2169831
|
-0.157080 Millimoles per liter
Standard Deviation 0.7761282
|
-0.535500 Millimoles per liter
Standard Deviation 1.2302718
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.533120 Millimoles per liter
Standard Deviation 1.6805969
|
-0.566440 Millimoles per liter
Standard Deviation 1.0685283
|
-0.439824 Millimoles per liter
Standard Deviation 1.3090563
|
-0.414120 Millimoles per liter
Standard Deviation 0.8948673
|
-0.606900 Millimoles per liter
Standard Deviation 1.0361954
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.716380 Millimoles per liter
Standard Deviation 1.4324888
|
-0.982940 Millimoles per liter
Standard Deviation 1.2427511
|
-0.287885 Millimoles per liter
Standard Deviation 1.1923207
|
-0.257040 Millimoles per liter
Standard Deviation 0.7543661
|
-0.249900 Millimoles per liter
Standard Deviation 1.2544880
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.866320 Millimoles per liter
Standard Deviation 1.6805969
|
-0.066640 Millimoles per liter
Standard Deviation 0.8843306
|
-0.491803 Millimoles per liter
Standard Deviation 1.1108310
|
-0.842520 Millimoles per liter
Standard Deviation 0.7064873
|
-0.207060 Millimoles per liter
Standard Deviation 1.4392234
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.032920 Millimoles per liter
Standard Deviation 1.7088970
|
-0.466480 Millimoles per liter
Standard Deviation 1.1821793
|
-0.139944 Millimoles per liter
Standard Deviation 1.1809813
|
-1.013880 Millimoles per liter
Standard Deviation 0.9698843
|
-0.399840 Millimoles per liter
Standard Deviation 1.2423284
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-1.049580 Millimoles per liter
Standard Deviation 1.9204291
|
-1.166200 Millimoles per liter
Standard Deviation 1.6051804
|
-0.399840 Millimoles per liter
Standard Deviation 1.2290067
|
-0.882980 Millimoles per liter
Standard Deviation 0.9192335
|
-0.271320 Millimoles per liter
Standard Deviation 1.2493792
|
—
|
|
Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea
Urea, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.916300 Millimoles per liter
Standard Deviation 1.5165176
|
-0.533120 Millimoles per liter
Standard Deviation 1.2237107
|
-0.703885 Millimoles per liter
Standard Deviation 1.1463627
|
-0.949620 Millimoles per liter
Standard Deviation 1.1991034
|
-0.521220 Millimoles per liter
Standard Deviation 1.4681527
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 8 (pre dose), Day 14 (48 hours) post dose and Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points to analyze the chemistry parameter: cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Cholesterol, Day 8, (predose) n=5,6,25,7,13
|
—
|
—
|
—
|
0.08 Millimoles per liter
Standard Deviation 0.192
|
0.07 Millimoles per liter
Standard Deviation 0.631
|
0.16 Millimoles per liter
Standard Deviation 0.466
|
0.36 Millimoles per liter
Standard Deviation 0.369
|
0.38 Millimoles per liter
Standard Deviation 0.440
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14
|
—
|
—
|
—
|
-0.05 Millimoles per liter
Standard Deviation 0.373
|
0.23 Millimoles per liter
Standard Deviation 0.589
|
0.23 Millimoles per liter
Standard Deviation 0.531
|
0.40 Millimoles per liter
Standard Deviation 0.696
|
0.38 Millimoles per liter
Standard Deviation 0.647
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Cholesterol, FU (Day 28), n= 6,6,25,7,14
|
—
|
—
|
—
|
-0.28 Millimoles per liter
Standard Deviation 0.147
|
0.15 Millimoles per liter
Standard Deviation 0.619
|
-0.04 Millimoles per liter
Standard Deviation 0.461
|
-0.29 Millimoles per liter
Standard Deviation 0.955
|
-0.04 Millimoles per liter
Standard Deviation 0.434
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
HDL Cholesterol, Day 8, (predose) n=5,6,25,7,14
|
—
|
—
|
—
|
-0.03 Millimoles per liter
Standard Deviation 0.121
|
0.00 Millimoles per liter
Standard Deviation 0.167
|
-0.14 Millimoles per liter
Standard Deviation 0.235
|
-0.13 Millimoles per liter
Standard Deviation 0.150
|
-0.14 Millimoles per liter
Standard Deviation 0.203
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
HDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14
|
—
|
—
|
—
|
-0.08 Millimoles per liter
Standard Deviation 0.075
|
-0.10 Millimoles per liter
Standard Deviation 0.179
|
-0.18 Millimoles per liter
Standard Deviation 0.129
|
-0.08 Millimoles per liter
Standard Deviation 0.194
|
-0.20 Millimoles per liter
Standard Deviation 0.260
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
HDL Cholesterol, FU (Day 28), n= 6,6,25,7,14
|
—
|
—
|
—
|
0.02 Millimoles per liter
Standard Deviation 0.041
|
0.00 Millimoles per liter
Standard Deviation 0.179
|
-0.12 Millimoles per liter
Standard Deviation 0.277
|
0.01 Millimoles per liter
Standard Deviation 0.372
|
-0.14 Millimoles per liter
Standard Deviation 0.195
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
LDL Cholesterol, Day 8, (predose) n=5,6,25,7,13
|
—
|
—
|
—
|
0.08 Millimoles per liter
Standard Deviation 0.217
|
0.03 Millimoles per liter
Standard Deviation 0.463
|
0.27 Millimoles per liter
Standard Deviation 0.407
|
0.49 Millimoles per liter
Standard Deviation 0.453
|
0.42 Millimoles per liter
Standard Deviation 0.420
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
LDL Cholesterol, Day 14 (48 hours), n= 6,6,24,6,14
|
—
|
—
|
—
|
-0.03 Millimoles per liter
Standard Deviation 0.234
|
0.27 Millimoles per liter
Standard Deviation 0.388
|
0.33 Millimoles per liter
Standard Deviation 0.442
|
0.33 Millimoles per liter
Standard Deviation 0.615
|
0.47 Millimoles per liter
Standard Deviation 0.517
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
LDL Cholesterol, FU (Day 28),n= 6,6,25,7,14
|
—
|
—
|
—
|
-0.23 Millimoles per liter
Standard Deviation 0.216
|
0.12 Millimoles per liter
Standard Deviation 0.556
|
0.12 Millimoles per liter
Standard Deviation 0.456
|
-0.33 Millimoles per liter
Standard Deviation 0.565
|
0.06 Millimoles per liter
Standard Deviation 0.455
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Triglycerides, Day 8, (predose) n=5,6,25,7,13
|
—
|
—
|
—
|
0.12 Millimoles per liter
Standard Deviation 0.492
|
0.07 Millimoles per liter
Standard Deviation 0.137
|
0.08 Millimoles per liter
Standard Deviation 0.314
|
-0.04 Millimoles per liter
Standard Deviation 0.424
|
0.22 Millimoles per liter
Standard Deviation 0.215
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Triglycerides, Day 14 (48 hours), n= 6,6,24,6,14
|
—
|
—
|
—
|
0.20 Millimoles per liter
Standard Deviation 0.502
|
0.15 Millimoles per liter
Standard Deviation 0.266
|
0.18 Millimoles per liter
Standard Deviation 0.400
|
0.28 Millimoles per liter
Standard Deviation 0.479
|
0.26 Millimoles per liter
Standard Deviation 0.285
|
—
|
|
Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides
Triglycerides, FU (Day 28), n= 6,6,25,7,14
|
—
|
—
|
—
|
-0.12 Millimoles per liter
Standard Deviation 0.471
|
0.07 Millimoles per liter
Standard Deviation 0.356
|
-0.06 Millimoles per liter
Standard Deviation 0.349
|
0.06 Millimoles per liter
Standard Deviation 0.538
|
0.14 Millimoles per liter
Standard Deviation 0.665
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 8 (predose), Day 14 (48 hours) post dose and Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameter: Glucose
Day 8, (predose) n=5,6,25,7,13
|
—
|
—
|
—
|
0.02 Millimoles per liter
Standard Deviation 0.550
|
0.20 Millimoles per liter
Standard Deviation 0.237
|
-0.10 Millimoles per liter
Standard Deviation 0.278
|
-0.09 Millimoles per liter
Standard Deviation 0.398
|
-0.12 Millimoles per liter
Standard Deviation 0.394
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Glucose
Day 14 (48 hours), n= 6,6,24,6,14
|
—
|
—
|
—
|
0.15 Millimoles per liter
Standard Deviation 0.532
|
0.03 Millimoles per liter
Standard Deviation 0.350
|
-0.23 Millimoles per liter
Standard Deviation 0.275
|
0.00 Millimoles per liter
Standard Deviation 0.329
|
-0.21 Millimoles per liter
Standard Deviation 0.405
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Glucose
FU (Day 28), n= 6,6,25,7,14
|
—
|
—
|
—
|
0.05 Millimoles per liter
Standard Deviation 0.824
|
0.15 Millimoles per liter
Standard Deviation 0.389
|
-0.12 Millimoles per liter
Standard Deviation 0.375
|
0.20 Millimoles per liter
Standard Deviation 0.507
|
-0.02 Millimoles per liter
Standard Deviation 0.458
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
4.5 Micromoles per liter
Standard Deviation 7.29
|
6.8 Micromoles per liter
Standard Deviation 5.74
|
2.0 Micromoles per liter
Standard Deviation 8.62
|
3.0 Micromoles per liter
Standard Deviation 3.96
|
3.6 Micromoles per liter
Standard Deviation 7.44
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-2.3 Micromoles per liter
Standard Deviation 3.83
|
1.7 Micromoles per liter
Standard Deviation 3.83
|
1.2 Micromoles per liter
Standard Deviation 6.31
|
4.3 Micromoles per liter
Standard Deviation 5.05
|
3.6 Micromoles per liter
Standard Deviation 8.31
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.4 Micromoles per liter
Standard Deviation 0.89
|
0.2 Micromoles per liter
Standard Deviation 1.10
|
-0.3 Micromoles per liter
Standard Deviation 1.19
|
-0.3 Micromoles per liter
Standard Deviation 1.03
|
-0.3 Micromoles per liter
Standard Deviation 1.37
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
4.2 Micromoles per liter
Standard Deviation 6.88
|
7.8 Micromoles per liter
Standard Deviation 5.46
|
1.5 Micromoles per liter
Standard Deviation 7.08
|
8.5 Micromoles per liter
Standard Deviation 6.83
|
4.0 Micromoles per liter
Standard Deviation 7.92
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
1.2 Micromoles per liter
Standard Deviation 2.04
|
1.8 Micromoles per liter
Standard Deviation 2.40
|
2.3 Micromoles per liter
Standard Deviation 7.28
|
0.6 Micromoles per liter
Standard Deviation 4.35
|
-0.1 Micromoles per liter
Standard Deviation 3.90
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.7 Micromoles per liter
Standard Deviation 2.50
|
8.2 Micromoles per liter
Standard Deviation 3.87
|
-3.0 Micromoles per liter
Standard Deviation 5.30
|
6.1 Micromoles per liter
Standard Deviation 8.30
|
0.4 Micromoles per liter
Standard Deviation 3.23
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
4.7 Micromoles per liter
Standard Deviation 4.72
|
1.8 Micromoles per liter
Standard Deviation 3.43
|
1.9 Micromoles per liter
Standard Deviation 6.05
|
3.1 Micromoles per liter
Standard Deviation 3.24
|
1.4 Micromoles per liter
Standard Deviation 8.90
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.3 Micromoles per liter
Standard Deviation 5.72
|
3.3 Micromoles per liter
Standard Deviation 4.41
|
-2.2 Micromoles per liter
Standard Deviation 6.13
|
5.6 Micromoles per liter
Standard Deviation 7.23
|
0.5 Micromoles per liter
Standard Deviation 7.47
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
2.7 Micromoles per liter
Standard Deviation 7.74
|
13.8 Micromoles per liter
Standard Deviation 4.67
|
2.6 Micromoles per liter
Standard Deviation 6.31
|
6.9 Micromoles per liter
Standard Deviation 6.52
|
3.6 Micromoles per liter
Standard Deviation 9.71
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
5.8 Micromoles per liter
Standard Deviation 8.66
|
7.5 Micromoles per liter
Standard Deviation 5.39
|
0.8 Micromoles per liter
Standard Deviation 6.16
|
6.4 Micromoles per liter
Standard Deviation 3.46
|
4.7 Micromoles per liter
Standard Deviation 5.80
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
6.0 Micromoles per liter
Standard Deviation 5.10
|
15.3 Micromoles per liter
Standard Deviation 6.53
|
5.5 Micromoles per liter
Standard Deviation 8.81
|
10.2 Micromoles per liter
Standard Deviation 5.56
|
8.8 Micromoles per liter
Standard Deviation 6.22
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Creatinine, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.7 Micromoles per liter
Standard Deviation 8.91
|
4.5 Micromoles per liter
Standard Deviation 4.89
|
-0.3 Micromoles per liter
Standard Deviation 7.66
|
3.6 Micromoles per liter
Standard Deviation 3.55
|
1.7 Micromoles per liter
Standard Deviation 5.17
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.6 Micromoles per liter
Standard Deviation 0.55
|
0.0 Micromoles per liter
Standard Deviation 1.00
|
-0.4 Micromoles per liter
Standard Deviation 1.18
|
-1.5 Micromoles per liter
Standard Deviation 1.73
|
-0.5 Micromoles per liter
Standard Deviation 1.31
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.8 Micromoles per liter
Standard Deviation 0.45
|
-0.3 Micromoles per liter
Standard Deviation 0.82
|
-0.4 Micromoles per liter
Standard Deviation 1.03
|
-0.2 Micromoles per liter
Standard Deviation 0.41
|
0.0 Micromoles per liter
Standard Deviation 0.95
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.4 Micromoles per liter
Standard Deviation 0.55
|
-1.0 Micromoles per liter
Standard Deviation 0.82
|
-0.4 Micromoles per liter
Standard Deviation 1.20
|
-0.5 Micromoles per liter
Standard Deviation 1.22
|
-0.3 Micromoles per liter
Standard Deviation 1.36
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.4 Micromoles per liter
Standard Deviation 0.89
|
0.0 Micromoles per liter
Standard Deviation 1.26
|
0.0 Micromoles per liter
Standard Deviation 1.13
|
-0.6 Micromoles per liter
Standard Deviation 1.52
|
-0.3 Micromoles per liter
Standard Deviation 1.14
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.4 Micromoles per liter
Standard Deviation 0.55
|
-0.4 Micromoles per liter
Standard Deviation 1.14
|
-0.5 Micromoles per liter
Standard Deviation 0.99
|
-0.6 Micromoles per liter
Standard Deviation 1.52
|
-0.4 Micromoles per liter
Standard Deviation 1.24
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation 0.82
|
0.0 Micromoles per liter
Standard Deviation 0.82
|
-0.4 Micromoles per liter
Standard Deviation 1.26
|
-2.5 Micromoles per liter
Standard Deviation 0.71
|
-0.4 Micromoles per liter
Standard Deviation 1.43
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.8 Micromoles per liter
Standard Deviation 0.45
|
-0.2 Micromoles per liter
Standard Deviation 0.98
|
-0.2 Micromoles per liter
Standard Deviation 1.14
|
-0.2 Micromoles per liter
Standard Deviation 1.30
|
-0.3 Micromoles per liter
Standard Deviation 1.30
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct Bilirubin, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-0.4 Micromoles per liter
Standard Deviation 0.55
|
-0.2 Micromoles per liter
Standard Deviation 0.84
|
-0.2 Micromoles per liter
Standard Deviation 1.40
|
-0.6 Micromoles per liter
Standard Deviation 0.89
|
-0.3 Micromoles per liter
Standard Deviation 1.48
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.8 Micromoles per liter
Standard Deviation 0.84
|
0.3 Micromoles per liter
Standard Deviation 1.21
|
0.7 Micromoles per liter
Standard Deviation 2.17
|
0.4 Micromoles per liter
Standard Deviation 1.52
|
0.2 Micromoles per liter
Standard Deviation 1.54
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.3 Micromoles per liter
Standard Deviation 1.97
|
-0.8 Micromoles per liter
Standard Deviation 2.14
|
-0.7 Micromoles per liter
Standard Deviation 4.03
|
-2.6 Micromoles per liter
Standard Deviation 2.94
|
-0.9 Micromoles per liter
Standard Deviation 4.01
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.5 Micromoles per liter
Standard Deviation 2.59
|
0.2 Micromoles per liter
Standard Deviation 0.98
|
-0.7 Micromoles per liter
Standard Deviation 3.53
|
0.3 Micromoles per liter
Standard Deviation 1.50
|
0.3 Micromoles per liter
Standard Deviation 3.50
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.8 Micromoles per liter
Standard Deviation 1.72
|
-2.2 Micromoles per liter
Standard Deviation 1.72
|
-1.0 Micromoles per liter
Standard Deviation 3.67
|
-1.1 Micromoles per liter
Standard Deviation 3.63
|
-0.7 Micromoles per liter
Standard Deviation 3.58
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.7 Micromoles per liter
Standard Deviation 2.07
|
-0.5 Micromoles per liter
Standard Deviation 1.38
|
-0.9 Micromoles per liter
Standard Deviation 3.73
|
-1.3 Micromoles per liter
Standard Deviation 3.64
|
-0.1 Micromoles per liter
Standard Deviation 3.65
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.8 Micromoles per liter
Standard Deviation 2.64
|
-0.2 Micromoles per liter
Standard Deviation 2.04
|
0.0 Micromoles per liter
Standard Deviation 3.52
|
-0.6 Micromoles per liter
Standard Deviation 4.20
|
-0.1 Micromoles per liter
Standard Deviation 3.41
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.8 Micromoles per liter
Standard Deviation 1.83
|
0.2 Micromoles per liter
Standard Deviation 2.48
|
-1.3 Micromoles per liter
Standard Deviation 3.31
|
-1.4 Micromoles per liter
Standard Deviation 3.69
|
-1.1 Micromoles per liter
Standard Deviation 3.17
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-0.3 Micromoles per liter
Standard Deviation 1.37
|
-0.3 Micromoles per liter
Standard Deviation 1.86
|
-1.0 Micromoles per liter
Standard Deviation 3.65
|
-1.8 Micromoles per liter
Standard Deviation 3.54
|
-0.4 Micromoles per liter
Standard Deviation 3.75
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-1.7 Micromoles per liter
Standard Deviation 2.07
|
1.2 Micromoles per liter
Standard Deviation 2.64
|
0.1 Micromoles per liter
Standard Deviation 3.71
|
-0.8 Micromoles per liter
Standard Deviation 3.60
|
0.0 Micromoles per liter
Standard Deviation 3.35
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin
Bilirubin, Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-1.2 Micromoles per liter
Standard Deviation 1.17
|
1.0 Micromoles per liter
Standard Deviation 1.79
|
-0.4 Micromoles per liter
Standard Deviation 4.71
|
-1.0 Micromoles per liter
Standard Deviation 3.74
|
0.2 Micromoles per liter
Standard Deviation 4.02
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-1.0 Grams per liter
Standard Deviation 2.28
|
-1.2 Grams per liter
Standard Deviation 1.94
|
-0.5 Grams per liter
Standard Deviation 3.43
|
0.4 Grams per liter
Standard Deviation 3.26
|
0.4 Grams per liter
Standard Deviation 4.05
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.7 Grams per liter
Standard Deviation 3.08
|
-1.0 Grams per liter
Standard Deviation 2.45
|
-0.3 Grams per liter
Standard Deviation 2.72
|
2.9 Grams per liter
Standard Deviation 2.12
|
-0.3 Grams per liter
Standard Deviation 3.36
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-2.5 Grams per liter
Standard Deviation 4.32
|
-3.5 Grams per liter
Standard Deviation 1.87
|
-2.0 Grams per liter
Standard Deviation 4.14
|
0.2 Grams per liter
Standard Deviation 1.94
|
-1.8 Grams per liter
Standard Deviation 3.85
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.5 Grams per liter
Standard Deviation 2.35
|
-1.0 Grams per liter
Standard Deviation 2.19
|
0.2 Grams per liter
Standard Deviation 3.34
|
1.7 Grams per liter
Standard Deviation 2.14
|
-0.9 Grams per liter
Standard Deviation 3.32
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1.5 Grams per liter
Standard Deviation 3.02
|
0.0 Grams per liter
Standard Deviation 2.37
|
-0.3 Grams per liter
Standard Deviation 2.78
|
5.9 Grams per liter
Standard Deviation 3.53
|
-0.6 Grams per liter
Standard Deviation 2.82
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.7 Grams per liter
Standard Deviation 5.61
|
-1.3 Grams per liter
Standard Deviation 1.75
|
-0.1 Grams per liter
Standard Deviation 2.53
|
2.1 Grams per liter
Standard Deviation 2.48
|
0.0 Grams per liter
Standard Deviation 2.86
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 8 predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.0 Grams per liter
Standard Deviation 3.03
|
-0.8 Grams per liter
Standard Deviation 2.48
|
-0.5 Grams per liter
Standard Deviation 2.69
|
1.4 Grams per liter
Standard Deviation 2.15
|
0.1 Grams per liter
Standard Deviation 2.56
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.5 Grams per liter
Standard Deviation 4.04
|
0.7 Grams per liter
Standard Deviation 1.97
|
-0.6 Grams per liter
Standard Deviation 3.12
|
1.7 Grams per liter
Standard Deviation 1.98
|
0.0 Grams per liter
Standard Deviation 4.08
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
-2.2 Grams per liter
Standard Deviation 3.31
|
-1.7 Grams per liter
Standard Deviation 2.50
|
-1.8 Grams per liter
Standard Deviation 3.57
|
2.0 Grams per liter
Standard Deviation 2.00
|
-0.2 Grams per liter
Standard Deviation 3.79
|
—
|
|
Part 2: Change From Baseline in Chemistry Parameter: Protein
Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0.0 Grams per liter
Standard Deviation 2.53
|
-0.8 Grams per liter
Standard Deviation 2.64
|
-1.1 Grams per liter
Standard Deviation 3.90
|
2.7 Grams per liter
Standard Deviation 2.42
|
0.6 Grams per liter
Standard Deviation 3.90
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: Safety Population
Urine samples were collected analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Urinalysis
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12,and 14 (pre dose and 72 hours) and Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 1, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 4.76
|
1.2 Millimeters of mercury (mmHg)
Standard Deviation 9.87
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 4.68
|
2.9 Millimeters of mercury (mmHg)
Standard Deviation 5.76
|
-1.1 Millimeters of mercury (mmHg)
Standard Deviation 8.48
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 2.88
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 10.30
|
0.6 Millimeters of mercury (mmHg)
Standard Deviation 6.47
|
2.6 Millimeters of mercury (mmHg)
Standard Deviation 3.40
|
-2.6 Millimeters of mercury (mmHg)
Standard Deviation 7.84
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 5.79
|
-0.5 Millimeters of mercury (mmHg)
Standard Deviation 9.20
|
-2.2 Millimeters of mercury (mmHg)
Standard Deviation 6.33
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 5.42
|
-3.3 Millimeters of mercury (mmHg)
Standard Deviation 12.67
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.7 Millimeters of mercury (mmHg)
Standard Deviation 5.09
|
1.2 Millimeters of mercury (mmHg)
Standard Deviation 9.87
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 5.72
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 7.48
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 12.94
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 8, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 3.73
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 9.85
|
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 6.19
|
4.3 Millimeters of mercury (mmHg)
Standard Deviation 5.65
|
-1.4 Millimeters of mercury (mmHg)
Standard Deviation 11.80
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 3.06
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 9.37
|
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 6.66
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 4.11
|
-5.2 Millimeters of mercury (mmHg)
Standard Deviation 12.77
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 2.64
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 10.15
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 5.70
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 5.71
|
-4.6 Millimeters of mercury (mmHg)
Standard Deviation 11.88
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 14, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.8 Millimeters of mercury (mmHg)
Standard Deviation 3.97
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 14.00
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 7.31
|
3.8 Millimeters of mercury (mmHg)
Standard Deviation 5.56
|
-4.1 Millimeters of mercury (mmHg)
Standard Deviation 12.33
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, Day 14, 72 hours, n=6,6,25,7,14
|
—
|
—
|
—
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 3.33
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 10.98
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 6.21
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 6.85
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 11.07
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
SBP, follow up, n=6,6,25,7,14
|
—
|
—
|
—
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation 8.56
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 1.75
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 6.43
|
4.1 Millimeters of mercury (mmHg)
Standard Deviation 7.60
|
1.2 Millimeters of mercury (mmHg)
Standard Deviation 7.03
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 1, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.7 Millimeters of mercury (mmHg)
Standard Deviation 5.65
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 2.76
|
-0.9 Millimeters of mercury (mmHg)
Standard Deviation 5.78
|
2.3 Millimeters of mercury (mmHg)
Standard Deviation 5.41
|
-0.8 Millimeters of mercury (mmHg)
Standard Deviation 5.73
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 3.03
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 5.20
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 6.93
|
2.2 Millimeters of mercury (mmHg)
Standard Deviation 4.28
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 4.76
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.7 Millimeters of mercury (mmHg)
Standard Deviation 5.85
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 5.68
|
-1.6 Millimeters of mercury (mmHg)
Standard Deviation 7.18
|
3.1 Millimeters of mercury (mmHg)
Standard Deviation 3.80
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 4.94
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-4.7 Millimeters of mercury (mmHg)
Standard Deviation 7.17
|
2.0 Millimeters of mercury (mmHg)
Standard Deviation 2.19
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 5.21
|
1.9 Millimeters of mercury (mmHg)
Standard Deviation 4.06
|
-1.6 Millimeters of mercury (mmHg)
Standard Deviation 4.62
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 8, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-2.5 Millimeters of mercury (mmHg)
Standard Deviation 7.89
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 3.73
|
-1.3 Millimeters of mercury (mmHg)
Standard Deviation 6.52
|
0.1 Millimeters of mercury (mmHg)
Standard Deviation 4.63
|
0.3 Millimeters of mercury (mmHg)
Standard Deviation 4.70
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-3.2 Millimeters of mercury (mmHg)
Standard Deviation 6.27
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 4.71
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 5.79
|
3.3 Millimeters of mercury (mmHg)
Standard Deviation 4.96
|
-2.1 Millimeters of mercury (mmHg)
Standard Deviation 7.13
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 12, n=6,6,25,7,14
|
—
|
—
|
—
|
0.7 Millimeters of mercury (mmHg)
Standard Deviation 1.86
|
0.5 Millimeters of mercury (mmHg)
Standard Deviation 4.85
|
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 6.16
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 5.01
|
-2.3 Millimeters of mercury (mmHg)
Standard Deviation 7.45
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 14, predose, n=6,6,24,6,14
|
—
|
—
|
—
|
0.2 Millimeters of mercury (mmHg)
Standard Deviation 3.13
|
-0.8 Millimeters of mercury (mmHg)
Standard Deviation 2.56
|
-1.0 Millimeters of mercury (mmHg)
Standard Deviation 6.93
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 3.76
|
-1.9 Millimeters of mercury (mmHg)
Standard Deviation 7.07
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, Day 14, 72 hours n=6,6,24,6,14
|
—
|
—
|
—
|
-0.3 Millimeters of mercury (mmHg)
Standard Deviation 2.88
|
-1.7 Millimeters of mercury (mmHg)
Standard Deviation 2.42
|
-2.0 Millimeters of mercury (mmHg)
Standard Deviation 6.03
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 4.67
|
-1.6 Millimeters of mercury (mmHg)
Standard Deviation 4.50
|
—
|
|
Part 2: Change From Baseline in Vital Signs: SBP and DBP
DBP, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-3.0 Millimeters of mercury (mmHg)
Standard Deviation 8.56
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 1.75
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 6.43
|
7 Millimeters of mercury (mmHg)
Standard Deviation 4.1
|
1.2 Millimeters of mercury (mmHg)
Standard Deviation 7.03
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 1, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.3 Beats per minute
Standard Deviation 4.27
|
0.6 Beats per minute
Standard Deviation 1.86
|
1.6 Beats per minute
Standard Deviation 4.98
|
-3.4 Beats per minute
Standard Deviation 3.31
|
5.3 Beats per minute
Standard Deviation 5.61
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.3 Beats per minute
Standard Deviation 4.18
|
0.5 Beats per minute
Standard Deviation 4.93
|
2.5 Beats per minute
Standard Deviation 7.22
|
2.1 Beats per minute
Standard Deviation 5.79
|
3.1 Beats per minute
Standard Deviation 5.66
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1.5 Beats per minute
Standard Deviation 3.27
|
1.5 Beats per minute
Standard Deviation 5.96
|
0.2 Beats per minute
Standard Deviation 6.17
|
2.7 Beats per minute
Standard Deviation 7.63
|
4.1 Beats per minute
Standard Deviation 6.34
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.8 Beats per minute
Standard Deviation 3.60
|
2.5 Beats per minute
Standard Deviation 5.47
|
0.8 Beats per minute
Standard Deviation 6.55
|
3.4 Beats per minute
Standard Deviation 4.43
|
3.2 Beats per minute
Standard Deviation 7.16
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 8, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.5 Beats per minute
Standard Deviation 3.94
|
1.3 Beats per minute
Standard Deviation 4.89
|
1.4 Beats per minute
Standard Deviation 8.02
|
2.7 Beats per minute
Standard Deviation 6.70
|
2.1 Beats per minute
Standard Deviation 5.34
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.5 Beats per minute
Standard Deviation 3.94
|
3.3 Beats per minute
Standard Deviation 5.79
|
1.0 Beats per minute
Standard Deviation 7.21
|
0.4 Beats per minute
Standard Deviation 5.62
|
1.8 Beats per minute
Standard Deviation 6.93
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
3.5 Beats per minute
Standard Deviation 4.51
|
2.5 Beats per minute
Standard Deviation 7.87
|
-0.1 Beats per minute
Standard Deviation 8.02
|
3.1 Beats per minute
Standard Deviation 10.64
|
2.5 Beats per minute
Standard Deviation 8.12
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
3.5 Beats per minute
Standard Deviation 3.62
|
-0.2 Beats per minute
Standard Deviation 5.12
|
-0.2 Beats per minute
Standard Deviation 7.40
|
1.5 Beats per minute
Standard Deviation 3.83
|
0.3 Beats per minute
Standard Deviation 4.61
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
Day 14, 72 hours, n=6,6,25,6,14
|
—
|
—
|
—
|
7.0 Beats per minute
Standard Deviation 7.62
|
1.8 Beats per minute
Standard Deviation 4.40
|
2.9 Beats per minute
Standard Deviation 6.91
|
4.2 Beats per minute
Standard Deviation 4.31
|
5.0 Beats per minute
Standard Deviation 6.82
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Pulse Rate
FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
6.3 Beats per minute
Standard Deviation 6.62
|
-1.3 Beats per minute
Standard Deviation 10.63
|
0.8 Beats per minute
Standard Deviation 9.36
|
9.6 Beats per minute
Standard Deviation 7.96
|
6.3 Beats per minute
Standard Deviation 7.33
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.44 Degree Celsius
Standard Deviation 0.512
|
0.28 Degree Celsius
Standard Deviation 0.271
|
0.04 Degree Celsius
Standard Deviation 0.425
|
0.11 Degree Celsius
Standard Deviation 0.204
|
0.14 Degree Celsius
Standard Deviation 0.374
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 8, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.05 Degree Celsius
Standard Deviation 0.373
|
0.20 Degree Celsius
Standard Deviation 0.322
|
0.05 Degree Celsius
Standard Deviation 0.255
|
-0.09 Degree Celsius
Standard Deviation 0.372
|
-0.02 Degree Celsius
Standard Deviation 0.379
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.25 Degree Celsius
Standard Deviation 0.281
|
0.18 Degree Celsius
Standard Deviation 0.331
|
-0.04 Degree Celsius
Standard Deviation 0.507
|
-0.11 Degree Celsius
Standard Deviation 0.279
|
0.14 Degree Celsius
Standard Deviation 0.367
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.33 Degree Celsius
Standard Deviation 0.489
|
0.25 Degree Celsius
Standard Deviation 0.226
|
-0.04 Degree Celsius
Standard Deviation 0.342
|
-0.11 Degree Celsius
Standard Deviation 0.491
|
0.14 Degree Celsius
Standard Deviation 0.405
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.30 Degree Celsius
Standard Deviation 0.498
|
0.10 Degree Celsius
Standard Deviation 0.593
|
-0.01 Degree Celsius
Standard Deviation 0.355
|
-0.10 Degree Celsius
Standard Deviation 0.289
|
0.09 Degree Celsius
Standard Deviation 0.455
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.23 Degree Celsius
Standard Deviation 0.489
|
0.23 Degree Celsius
Standard Deviation 0.314
|
-0.02 Degree Celsius
Standard Deviation 0.415
|
0.03 Degree Celsius
Standard Deviation 0.320
|
0.06 Degree Celsius
Standard Deviation 0.393
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
0.30 Degree Celsius
Standard Deviation 0.290
|
0.13 Degree Celsius
Standard Deviation 0.258
|
0.05 Degree Celsius
Standard Deviation 0.309
|
0.05 Degree Celsius
Standard Deviation 0.266
|
-0.02 Degree Celsius
Standard Deviation 0.395
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 14, 72 hours, n=6,6,25,6,14
|
—
|
—
|
—
|
0.30 Degree Celsius
Standard Deviation 0.310
|
0.15 Degree Celsius
Standard Deviation 0.302
|
0.06 Degree Celsius
Standard Deviation 0.330
|
0.22 Degree Celsius
Standard Deviation 0.256
|
0.06 Degree Celsius
Standard Deviation 0.363
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0.42 Degree Celsius
Standard Deviation 0.264
|
0.37 Degree Celsius
Standard Deviation 0.441
|
0.04 Degree Celsius
Standard Deviation 0.586
|
0.23 Degree Celsius
Standard Deviation 0.364
|
0.21 Degree Celsius
Standard Deviation 0.317
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Temperature
Day 1, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.38 Degree Celsius
Standard Deviation 0.313
|
0.08 Degree Celsius
Standard Deviation 0.222
|
0.11 Degree Celsius
Standard Deviation 0.414
|
0.11 Degree Celsius
Standard Deviation 0.308
|
0.09 Degree Celsius
Standard Deviation 0.276
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12 and 14 (pre dose and 72 hours) and Follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 1, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.0 Breaths per minute
Standard Deviation 2.37
|
2.2 Breaths per minute
Standard Deviation 3.49
|
0.2 Breaths per minute
Standard Deviation 2.15
|
0.1 Breaths per minute
Standard Deviation 2.27
|
0.8 Breaths per minute
Standard Deviation 2.22
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 2, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.5 Breaths per minute
Standard Deviation 2.88
|
2.3 Breaths per minute
Standard Deviation 1.21
|
0.4 Breaths per minute
Standard Deviation 2.00
|
1.6 Breaths per minute
Standard Deviation 1.72
|
0.5 Breaths per minute
Standard Deviation 1.95
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 4, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.5 Breaths per minute
Standard Deviation 2.17
|
2.2 Breaths per minute
Standard Deviation 1.94
|
-0.2 Breaths per minute
Standard Deviation 1.50
|
0.6 Breaths per minute
Standard Deviation 2.44
|
0.2 Breaths per minute
Standard Deviation 1.53
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 6, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0.7 Breaths per minute
Standard Deviation 2.25
|
0.2 Breaths per minute
Standard Deviation 1.47
|
0.1 Breaths per minute
Standard Deviation 1.73
|
0.0 Breaths per minute
Standard Deviation 1.91
|
-0.4 Breaths per minute
Standard Deviation 1.65
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 8, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-1.2 Breaths per minute
Standard Deviation 3.06
|
1.7 Breaths per minute
Standard Deviation 1.03
|
0.0 Breaths per minute
Standard Deviation 2.37
|
0.6 Breaths per minute
Standard Deviation 1.90
|
0.5 Breaths per minute
Standard Deviation 1.91
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 10, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.3 Breaths per minute
Standard Deviation 3.20
|
1.5 Breaths per minute
Standard Deviation 2.35
|
0.9 Breaths per minute
Standard Deviation 1.69
|
0.6 Breaths per minute
Standard Deviation 0.98
|
0.5 Breaths per minute
Standard Deviation 1.74
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 12, predose, n=6,6,25,7,14
|
—
|
—
|
—
|
-0.7 Breaths per minute
Standard Deviation 2.25
|
2.3 Breaths per minute
Standard Deviation 2.80
|
0.4 Breaths per minute
Standard Deviation 1.96
|
-0.1 Breaths per minute
Standard Deviation 1.35
|
0.4 Breaths per minute
Standard Deviation 2.62
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 14, predose, n=6,6,25,6,14
|
—
|
—
|
—
|
-0.8 Breaths per minute
Standard Deviation 2.14
|
2.7 Breaths per minute
Standard Deviation 1.51
|
0.6 Breaths per minute
Standard Deviation 1.98
|
-0.2 Breaths per minute
Standard Deviation 2.23
|
0.4 Breaths per minute
Standard Deviation 2.24
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
Day 14, 72 hours, n=6,6,25,6,14
|
—
|
—
|
—
|
-1.0 Breaths per minute
Standard Deviation 1.41
|
2.7 Breaths per minute
Standard Deviation 1.63
|
0.5 Breaths per minute
Standard Deviation 1.56
|
-0.5 Breaths per minute
Standard Deviation 1.97
|
-0.4 Breaths per minute
Standard Deviation 1.98
|
—
|
|
Part 2: Change From Baseline in Vital Sign: Respiratory Rate
FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
-0.5 Breaths per minute
Standard Deviation 2.95
|
0.8 Breaths per minute
Standard Deviation 1.72
|
1.1 Breaths per minute
Standard Deviation 2.38
|
0.1 Breaths per minute
Standard Deviation 0.69
|
0.6 Breaths per minute
Standard Deviation 2.10
|
—
|
PRIMARY outcome
Timeframe: Day 1 (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5, 5.5, 6, 8, 12, 24 hours); Pre-dose on Days 3, 4, 6, 8, 10, 12; Day 14: Pre-dose, 1, 2, 4.5, 5, 6, 12, 24, 48, 72 and 96 hours post-dose and follow up (Day 28)Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
12-lead ECG were obtained at given time points. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=14 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1, 0.5 hours, n=4,0,0,0,2
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1,1 hour, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1, 1.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 1, 2hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 1, 2.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1, 3 hours n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 1, 3.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1, 4.5 hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1, 5hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1,5.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 1, 6hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 1, 8 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1, 12 hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 1, 24 hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 3, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 4, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 6, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 8, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 10, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 12, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, Predose, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, Day 14, 1hour, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 2 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 4.5hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 5hours, n=0,0,0,0,1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 6 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS Day 1, 3 hours n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 12 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 24 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 72 hours, n=6,6,24, 6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS,Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
CS, FU (Day 28), n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 1,0.5 hours, n=4,0,0,0,2
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 1,1 hour, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 1, 1.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 1, 2hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 1, 2.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 1, 3.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 1, 4.5 hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 1, 5hours n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 1,5.5 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 1, 6hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 1, 8 hours, n=4,0,0,0,1
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 1, 12 hours, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 3, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 4, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 6, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 8, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 10, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 12, Predose, n=6,6,25,7,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, Predose, n=6,6,24,6,14
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 14, 1hour, n=6,6,24,6,14
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 2 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 4.5 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 5hours, n=0,0,0,0,1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, Day 14, 6 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 12 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 24hours, n=6,6,24,6,14
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 48 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 72 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS,Day 14, 96 hours, n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal ECG Findings
NCS, FU (Day 28), n=6,6,24,6,14
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24 hours post-dosePopulation: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=4 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254
|
7.334 Hour*microgram per milliliter
Interval 5.415 to 9.933
|
21.666 Hour*microgram per milliliter
Interval 12.599 to 37.259
|
20.743 Hour*microgram per milliliter
Interval 13.296 to 32.362
|
0.056 Hour*microgram per milliliter
Interval 0.03 to 0.103
|
0.171 Hour*microgram per milliliter
Interval 0.126 to 0.231
|
0.576 Hour*microgram per milliliter
Interval 0.454 to 0.73
|
1.546 Hour*microgram per milliliter
Interval 1.178 to 2.028
|
4.177 Hour*microgram per milliliter
Interval 2.161 to 8.074
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dosePopulation: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254
|
14.068 Hour*microgram per milliliter
Interval 9.545 to 20.735
|
40.238 Hour*microgram per milliliter
Interval 24.234 to 66.812
|
37.626 Hour*microgram per milliliter
Interval 23.29 to 60.786
|
0.020 Hour*microgram per milliliter
Interval 0.005 to 0.08
|
0.184 Hour*microgram per milliliter
Interval 0.12 to 0.282
|
1.082 Hour*microgram per milliliter
Interval 0.875 to 1.338
|
2.816 Hour*microgram per milliliter
Interval 2.148 to 3.692
|
8.060 Hour*microgram per milliliter
Interval 4.228 to 15.367
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dosePopulation: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=3 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254
|
14.952 Hour*microgram per milliliter
Interval 9.88 to 22.629
|
42.989 Hour*microgram per milliliter
Interval 26.047 to 70.953
|
39.692 Hour*microgram per milliliter
Interval 24.094 to 65.389
|
0.057 Hour*microgram per milliliter
Interval 0.022 to 0.145
|
0.329 Hour*microgram per milliliter
Interval 0.232 to 0.467
|
1.227 Hour*microgram per milliliter
Interval 1.008 to 1.493
|
2.992 Hour*microgram per milliliter
Interval 2.281 to 3.924
|
8.539 Hour*microgram per milliliter
Interval 4.511 to 16.165
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dosePopulation: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Most of the concentrations were below limit of quantification (BLQ) at this dose group this value and/ or %AUC extrapolated was \>20% for all participants so this value should be used with caution. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=3 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254
|
22.620 Hour
Interval 18.069 to 28.316
|
23.737 Hour
Interval 19.747 to 28.533
|
20.761 Hour
Interval 16.171 to 26.654
|
7.886 Hour
Interval 3.427 to 18.145
|
20.486 Hour
Interval 16.45 to 25.514
|
25.332 Hour
Interval 20.741 to 30.938
|
21.221 Hour
Interval 17.557 to 25.65
|
22.838 Hour
Interval 20.268 to 25.734
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dosePopulation: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=3 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Clearance (CL/F) of GSK3640254
|
13.376 Liters/hour
Interval 8.838 to 20.244
|
9.305 Liters/hour
Interval 5.638 to 15.357
|
17.636 Liters/hour
Interval 10.705 to 29.053
|
17.685 Liters/hour
Interval 6.889 to 45.399
|
9.119 Liters/hour
Interval 6.428 to 12.937
|
8.152 Liters/hour
Interval 6.697 to 9.922
|
10.027 Liters/hour
Interval 7.645 to 13.15
|
11.711 Liters/hour
Interval 6.186 to 22.168
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dosePopulation: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254
Clast
|
0.024 Micrograms per milliliter
Interval 0.01 to 0.054
|
0.072 Micrograms per milliliter
Interval 0.043 to 0.12
|
0.054 Micrograms per milliliter
Interval 0.022 to 0.128
|
0.004 Micrograms per milliliter
Interval 0.003 to 0.005
|
0.005 Micrograms per milliliter
Interval 0.004 to 0.006
|
0.004 Micrograms per milliliter
Interval 0.003 to 0.005
|
0.005 Micrograms per milliliter
Interval 0.004 to 0.008
|
0.014 Micrograms per milliliter
Interval 0.008 to 0.026
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254
Cmax
|
0.579 Micrograms per milliliter
Interval 0.438 to 0.765
|
1.881 Micrograms per milliliter
Interval 1.15 to 3.077
|
1.724 Micrograms per milliliter
Interval 1.137 to 2.614
|
0.005 Micrograms per milliliter
Interval 0.004 to 0.006
|
0.014 Micrograms per milliliter
Interval 0.01 to 0.019
|
0.047 Micrograms per milliliter
Interval 0.034 to 0.064
|
0.130 Micrograms per milliliter
Interval 0.104 to 0.162
|
0.372 Micrograms per milliliter
Interval 0.19 to 0.73
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254
C24
|
0.245 Micrograms per milliliter
Interval 0.153 to 0.392
|
0.610 Micrograms per milliliter
Interval 0.356 to 1.046
|
0.579 Micrograms per milliliter
Interval 0.348 to 0.963
|
0.001 Micrograms per milliliter
Interval 0.0 to 0.005
|
0.005 Micrograms per milliliter
Interval 0.004 to 0.007
|
0.017 Micrograms per milliliter
Interval 0.013 to 0.023
|
0.043 Micrograms per milliliter
Interval 0.031 to 0.062
|
0.126 Micrograms per milliliter
Interval 0.061 to 0.261
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dosePopulation: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254
Tmax
|
3.000 Hour
Interval 1.983 to 4.0
|
3.250 Hour
Interval 2.0 to 6.0
|
3.250 Hour
Interval 2.0 to 4.5
|
3.500 Hour
Interval 2.5 to 6.0
|
4.500 Hour
Interval 2.0 to 5.0
|
3.500 Hour
Interval 2.5 to 5.0
|
4.000 Hour
Interval 2.5 to 5.0
|
3.750 Hour
Interval 2.0 to 5.0
|
—
|
|
Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254
Tlag
|
0.500 Hour
Interval 0.5 to 0.5
|
0.500 Hour
Interval 0.0 to 0.5
|
0.500 Hour
Interval 0.0 to 0.517
|
2.000 Hour
Interval 1.5 to 4.5
|
1.250 Hour
Interval 0.5 to 3.0
|
0.750 Hour
Interval 0.5 to 2.0
|
0.500 Hour
Interval 0.5 to 0.517
|
0.750 Hour
Interval 0.0 to 1.0
|
—
|
|
Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254
Tlast
|
95.667 Hour
Interval 95.667 to 96.0
|
95.667 Hour
Interval 95.483 to 96.1
|
95.542 Hour
Interval 95.25 to 96.0
|
6.017 Hour
Interval 4.5 to 48.0
|
24.017 Hour
Interval 24.0 to 48.017
|
72.008 Hour
Interval 72.0 to 96.083
|
96.000 Hour
Interval 72.033 to 96.0
|
96.000 Hour
Interval 95.317 to 96.017
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 and 24 hours post-dose on Day 1Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUC(0-24) of GSK3640254: Day 1
|
—
|
—
|
—
|
2.855 Hour*micrograms per milliliter
Geometric Coefficient of Variation 29.621
|
6.801 Hour*micrograms per milliliter
Geometric Coefficient of Variation 22.970
|
8.257 Hour*micrograms per milliliter
Geometric Coefficient of Variation 49.782
|
13.456 Hour*micrograms per milliliter
Geometric Coefficient of Variation 23.743
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax, C24 of GSK3640254 on Day 1
Cmax
|
—
|
—
|
—
|
0.215 Micrograms per milliliter
Geometric Coefficient of Variation 24.412
|
0.536 Micrograms per milliliter
Geometric Coefficient of Variation 22.959
|
0.614 Micrograms per milliliter
Geometric Coefficient of Variation 44.354
|
1.044 Micrograms per milliliter
Geometric Coefficient of Variation 29.225
|
—
|
—
|
|
Part 2: Cmax, C24 of GSK3640254 on Day 1
C24
|
—
|
—
|
—
|
0.082 Micrograms per milliliter
Geometric Coefficient of Variation 33.583
|
0.207 Micrograms per milliliter
Geometric Coefficient of Variation 22.856
|
0.238 Micrograms per milliliter
Geometric Coefficient of Variation 58.452
|
0.417 Micrograms per milliliter
Geometric Coefficient of Variation 39.681
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Tmax, Tlag of GSK3640254 on Day 1
Tmax
|
—
|
—
|
—
|
3.750 Hour
Interval 3.0 to 5.017
|
4.250 Hour
Interval 2.0 to 5.0
|
4.000 Hour
Interval 1.5 to 5.633
|
4.000 Hour
Interval 2.5 to 6.0
|
—
|
—
|
|
Part 2: Tmax, Tlag of GSK3640254 on Day 1
Tlag
|
—
|
—
|
—
|
0.508 Hour
Interval 0.5 to 0.55
|
0.500 Hour
Interval 0.5 to 0.5
|
0.500 Hour
Interval 0.0 to 1.5
|
0.500 Hour
Interval 0.0 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Tmax GSK3640254 on Day 14
|
—
|
—
|
—
|
3.775 Hour
Interval 2.5 to 5.0
|
4.000 Hour
Interval 1.5 to 4.5
|
3.750 Hour
Interval 1.5 to 5.5
|
4.250 Hour
Interval 1.5 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax of GSK3640254 on Day 14
|
—
|
—
|
—
|
0.414 Micrograms per milliliter
Geometric Coefficient of Variation 31.556
|
1.182 Micrograms per milliliter
Geometric Coefficient of Variation 10.264
|
1.402 Micrograms per milliliter
Geometric Coefficient of Variation 30.839
|
2.156 Micrograms per milliliter
Geometric Coefficient of Variation 20.360
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14
|
—
|
—
|
—
|
6.282 hour* micrograms per milliliter
Geometric Coefficient of Variation 34.010
|
17.506 hour* micrograms per milliliter
Geometric Coefficient of Variation 13.794
|
21.501 hour* micrograms per milliliter
Geometric Coefficient of Variation 34.205
|
31.954 hour* micrograms per milliliter
Geometric Coefficient of Variation 35.380
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The PK parameter name for Part 2 (Day 14) trough concentration was changed using Phoenix WinNonlin 8 from Ct to Ctrough. Day 15 Ctrough values were used for dose proportionality and time to steady-state assessments.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14
|
—
|
—
|
—
|
0.186 micrograms per milliliter
Geometric Coefficient of Variation 35.128
|
0.558 micrograms per milliliter
Geometric Coefficient of Variation 21.407
|
0.630 micrograms per milliliter
Geometric Coefficient of Variation 37.814
|
0.980 micrograms per milliliter
Geometric Coefficient of Variation 41.815
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: T1/2 of GSK3640254: Day 14
|
—
|
—
|
—
|
24.847 Hour
Geometric Coefficient of Variation 5.087
|
28.358 Hour
Geometric Coefficient of Variation 19.199
|
22.125 Hour
Geometric Coefficient of Variation 14.515
|
22.350 Hour
Geometric Coefficient of Variation 12.641
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: CL/F of GSK3640254: Day 14
|
—
|
—
|
—
|
7.959 Liter per hour
Geometric Coefficient of Variation 34.010
|
5.712 Liter per hour
Geometric Coefficient of Variation 13.794
|
9.302 Liter per hour
Geometric Coefficient of Variation 34.205
|
10.014 Liter per hour
Geometric Coefficient of Variation 35.380
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1
|
14.952 hour*micrograms per mililiter
Interval 9.88 to 22.629
|
42.989 hour*micrograms per mililiter
Interval 26.047 to 70.953
|
39.692 hour*micrograms per mililiter
Interval 24.094 to 65.389
|
0.057 hour*micrograms per mililiter
Interval 0.022 to 0.145
|
0.329 hour*micrograms per mililiter
Interval 0.232 to 0.467
|
1.1227 hour*micrograms per mililiter
Interval 1.008 to 1.493
|
2.992 hour*micrograms per mililiter
Interval 2.281 to 3.924
|
8.539 hour*micrograms per mililiter
Interval 4.511 to 16.165
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1
|
7.334 hour*micrograms per mililiter
Interval 5.415 to 9.933
|
21.666 hour*micrograms per mililiter
Interval 12.599 to 37.259
|
20.743 hour*micrograms per mililiter
Interval 13.296 to 32.362
|
0.056 hour*micrograms per mililiter
Interval 0.03 to 0.103
|
0.171 hour*micrograms per mililiter
Interval 0.126 to 0.231
|
0.576 hour*micrograms per mililiter
Interval 0.454 to 0.73
|
1.546 hour*micrograms per mililiter
Interval 1.178 to 2.028
|
4.177 hour*micrograms per mililiter
Interval 2.161 to 8.074
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
n=6 Participants
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
n=6 Participants
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
n=6 Participants
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=6 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
n=6 Participants
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1
|
0.579 Micrograms per mililiter
Interval 0.438 to 0.765
|
1.881 Micrograms per mililiter
Interval 1.15 to 3.077
|
1.724 Micrograms per mililiter
Interval 1.137 to 2.614
|
0.005 Micrograms per mililiter
Interval 0.004 to 0.006
|
0.014 Micrograms per mililiter
Interval 0.01 to 0.019
|
0.047 Micrograms per mililiter
Interval 0.034 to 0.064
|
0.130 Micrograms per mililiter
Interval 0.104 to 0.162
|
0.372 Micrograms per mililiter
Interval 0.19 to 0.73
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14
|
—
|
—
|
—
|
6.282 hour*microgram per milliliter
Geometric Coefficient of Variation 34.010
|
17.506 hour*microgram per milliliter
Geometric Coefficient of Variation 13.794
|
21.501 hour*microgram per milliliter
Geometric Coefficient of Variation 34.205
|
31.954 hour*microgram per milliliter
Geometric Coefficient of Variation 35.380
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14
|
—
|
—
|
—
|
0.205 Micrograms per milliliter
Geometric Coefficient of Variation 33.414
|
0.593 Micrograms per milliliter
Geometric Coefficient of Variation 16.359
|
0.615 Micrograms per milliliter
Geometric Coefficient of Variation 74.191
|
1.255 Micrograms per milliliter
Geometric Coefficient of Variation 37.220
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=24 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=6 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14
|
—
|
—
|
—
|
0.414 Microgram per milliliter
Geometric Coefficient of Variation 31.556
|
1.182 Microgram per milliliter
Geometric Coefficient of Variation 10.264
|
1.402 Microgram per milliliter
Geometric Coefficient of Variation 30.839
|
2.156 Microgram per milliliter
Geometric Coefficient of Variation 20.360
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14
|
—
|
—
|
—
|
2.2005 Ratio of AUC(0-tau)
Interval 1.9116 to 2.533
|
2.5739 Ratio of AUC(0-tau)
Interval 2.2067 to 3.0022
|
2.6167 Ratio of AUC(0-tau)
Interval 2.346 to 2.9185
|
2.3634 Ratio of AUC(0-tau)
Interval 1.7579 to 3.1774
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14
|
—
|
—
|
—
|
1.9276 Ratio of Cmax
Interval 1.6283 to 2.2818
|
2.2069 Ratio of Cmax
Interval 1.836 to 2.6528
|
2.2994 Ratio of Cmax
Interval 2.0872 to 2.5331
|
2.0650 Ratio of Cmax
Interval 1.6064 to 2.6545
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 15 dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 15 and Day 2, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15
|
—
|
—
|
—
|
2.1408 Ratio of Ctau
Interval 1.9402 to 2.3621
|
2.5847 Ratio of Ctau
Interval 2.1437 to 3.1165
|
2.5335 Ratio of Ctau
Interval 2.2133 to 2.9001
|
2.1666 Ratio of Ctau
Interval 1.4908 to 3.1488
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 2,3,4,6,8,10,12 and 14Population: PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 14 predose
|
—
|
—
|
—
|
214.16 Nanogram per milliliter
Standard Deviation 66.980
|
599.45 Nanogram per milliliter
Standard Deviation 97.262
|
706.76 Nanogram per milliliter
Standard Deviation 299.450
|
1324.29 Nanogram per milliliter
Standard Deviation 470.703
|
—
|
—
|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 2 Predose
|
—
|
—
|
—
|
90.20 Nanogram per milliliter
Standard Deviation 25.312
|
221.55 Nanogram per milliliter
Standard Deviation 55.722
|
283.37 Nanogram per milliliter
Standard Deviation 137.243
|
476.58 Nanogram per milliliter
Standard Deviation 197.909
|
—
|
—
|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 3 Predose
|
—
|
—
|
—
|
155.93 Nanogram per milliliter
Standard Deviation 41.869
|
449.82 Nanogram per milliliter
Standard Deviation 68.287
|
517.96 Nanogram per milliliter
Standard Deviation 239.825
|
753.02 Nanogram per milliliter
Standard Deviation 174.186
|
—
|
—
|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 4 Predose
|
—
|
—
|
—
|
196.25 Nanogram per milliliter
Standard Deviation 55.807
|
524.87 Nanogram per milliliter
Standard Deviation 120.723
|
667.45 Nanogram per milliliter
Standard Deviation 295.479
|
926.40 Nanogram per milliliter
Standard Deviation 235.884
|
—
|
—
|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 6 Predose
|
—
|
—
|
—
|
214.64 Nanogram per milliliter
Standard Deviation 75.891
|
550.48 Nanogram per milliliter
Standard Deviation 125.873
|
701.98 Nanogram per milliliter
Standard Deviation 349.091
|
969.06 Nanogram per milliliter
Standard Deviation 225.600
|
—
|
—
|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 8 Predose
|
—
|
—
|
—
|
230.50 Nanogram per milliliter
Standard Deviation 77.819
|
595.26 Nanogram per milliliter
Standard Deviation 151.167
|
712.79 Nanogram per milliliter
Standard Deviation 342.941
|
936.45 Nanogram per milliliter
Standard Deviation 278.866
|
—
|
—
|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 10 Predose
|
—
|
—
|
—
|
218.97 Nanogram per milliliter
Standard Deviation 74.858
|
604.52 Nanogram per milliliter
Standard Deviation 137.121
|
802.81 Nanogram per milliliter
Standard Deviation 272.000
|
1051.91 Nanogram per milliliter
Standard Deviation 375.261
|
—
|
—
|
|
Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14
Day 12 predose
|
—
|
—
|
—
|
221.10 Nanogram per milliliter
Standard Deviation 75.744
|
628.86 Nanogram per milliliter
Standard Deviation 114.448
|
726.13 Nanogram per milliliter
Standard Deviation 300.263
|
1182.80 Nanogram per milliliter
Standard Deviation 354.948
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1
|
—
|
—
|
—
|
0.215 Microgram per milliliter
Geometric Coefficient of Variation 24.412
|
0.536 Microgram per milliliter
Geometric Coefficient of Variation 22.959
|
0.614 Microgram per milliliter
Geometric Coefficient of Variation 44.354
|
1.044 Microgram per milliliter
Geometric Coefficient of Variation 29.225
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dosePopulation: PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 400 mg
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 700 mg
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 2: GSK3640254 50 mg
n=6 Participants
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: GSK3640254 100 mg
n=6 Participants
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 1: GSK3640254 10 mg
n=25 Participants
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 30mg
n=7 Participants
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1: GSK3640254 100 mg
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1
|
—
|
—
|
—
|
2.855 hour*micrograms per mililiter
Geometric Coefficient of Variation 29.621
|
6.801 hour*micrograms per mililiter
Geometric Coefficient of Variation 22.970
|
8.257 hour*micrograms per mililiter
Geometric Coefficient of Variation 49.782
|
13.456 hour*micrograms per mililiter
Geometric Coefficient of Variation 23.743
|
—
|
—
|
Adverse Events
Part 1:GSK3640254 1 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1:GSK3640254 3 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1:GSK3640254 10 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1:GSK3640254 30 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1:GSK3640254 100 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1:GSK3640254 200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1:GSK3640254 400 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1:GSK3640254 700 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Single Dose Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2: Repeated Dose GSK3640254 50 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: Repeated Dose GSK3640254 100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Repeated Dose GSK3640254 200mg +Expansion
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part 2: Repeated Dose GSK3640254 320 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2: Repeated Dose Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1:GSK3640254 1 mg
n=6 participants at risk
Participants received single dose of GSK3640254 1 mg following a moderate fat meal on Day 1
|
Part 1:GSK3640254 3 mg
n=6 participants at risk
Participants received single dose of GSK3640254 3 mg following a moderate fat meal on Day 1
|
Part 1:GSK3640254 10 mg
n=6 participants at risk
Participants received single dose of GSK3640254 10 mg following a moderate fat meal on Day 1
|
Part 1:GSK3640254 30 mg
n=6 participants at risk
Participants received single dose of GSK3640254 30 mg following a moderate fat meal on Day 1
|
Part 1:GSK3640254 100 mg
n=6 participants at risk
Participants received single dose of GSK3640254 100 mg following a moderate fat meal on Day 1
|
Part 1:GSK3640254 200 mg
n=6 participants at risk
Participants received single dose of GSK3640254 200 mg following a moderate fat meal on Day 1
|
Part 1:GSK3640254 400 mg
n=6 participants at risk
Participants received single dose of GSK3640254 400 mg following a moderate fat meal on Day 1
|
Part 1:GSK3640254 700 mg
n=6 participants at risk
Participants received single dose of GSK3640254 700 mg following a moderate fat meal on Day 1
|
Part 1: Single Dose Placebo
n=16 participants at risk
Participants received single dose of matching placebo following a moderate fat meal on Day 1
|
Part 2: Repeated Dose GSK3640254 50 mg
n=6 participants at risk
Participants received repeated dose of GSK3640254 50 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 100 mg
n=6 participants at risk
Participants received repeated dose of GSK3640254 100 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 200mg +Expansion
n=25 participants at risk
Participants received repeated dose of GSK3640254 200 mg once daily up to 14 days
|
Part 2: Repeated Dose GSK3640254 320 mg
n=7 participants at risk
Participants received repeated dose of GSK3640254 320 mg once daily up to 14 days
|
Part 2: Repeated Dose Placebo
n=14 participants at risk
Participants received repeated dose of matching placebo once daily up to 14 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
33.3%
2/6 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
33.3%
2/6 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
6.2%
1/16 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
50.0%
3/6 • Number of events 3 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
12.0%
3/25 • Number of events 5 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
28.6%
2/7 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
42.9%
6/14 • Number of events 6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
33.3%
2/6 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
8.0%
2/25 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
33.3%
2/6 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
6.2%
1/16 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
33.3%
2/6 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
6.2%
1/16 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Faeces soft
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
12.5%
2/16 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
28.0%
7/25 • Number of events 7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
12.0%
3/25 • Number of events 3 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
6.2%
1/16 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Limb injury
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
6.2%
1/16 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
6.2%
1/16 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
6.2%
1/16 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
8.0%
2/25 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
General disorders
Fatigue
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
33.3%
2/6 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
2/14 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
General disorders
Catheter site bruise
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
General disorders
Feeling cold
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
General disorders
Mass
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
28.6%
2/7 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
8.0%
2/25 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
2/14 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
4.0%
1/25 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
8.0%
2/25 • Number of events 2 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Infections and infestations
Abscess
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
7.1%
1/14 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
16.7%
1/6 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/7 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/16 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/6 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/25 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
14.3%
1/7 • Number of events 1 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
0.00%
0/14 • On-treatment and post-treatment non-serious adverse events and serious adverse events were collected up to Day 15 for Part 1 and Day 28 for Part 2 of the study.
Safety Population was used to collect the adverse events
|
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