Trial Outcomes & Findings for A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants (NCT NCT04263142)
NCT ID: NCT04263142
Last Updated: 2021-03-03
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis.
COMPLETED
PHASE1
39 participants
pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
2021-03-03
Participant Flow
This was a 2-part, randomized, single dose cross-over study conducted at a single center in the United States to assess the relative bioavailability and food effect of GSK3640254 tablet and capsule formulations in healthy participants.
A total of 39 participants were enrolled in Part 1 (18 participants) and Part 2 (21 participants) of the study.
Participant milestones
| Measure |
Part 1: Treatment Sequence AB
Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 1: Treatment Sequence BA
Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence CDE
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence DEC
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence ECD
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
|---|---|---|---|---|---|
|
Part 1 Period 1 (Day 1)
STARTED
|
9
|
9
|
0
|
0
|
0
|
|
Part 1 Period 1 (Day 1)
COMPLETED
|
9
|
9
|
0
|
0
|
0
|
|
Part 1 Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 Period 2 (Up to Day 5)
STARTED
|
9
|
9
|
0
|
0
|
0
|
|
Part 1 Period 2 (Up to Day 5)
COMPLETED
|
9
|
9
|
0
|
0
|
0
|
|
Part 1 Period 2 (Up to Day 5)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 Period 1 (Day 1)
STARTED
|
0
|
0
|
7
|
7
|
7
|
|
Part 2 Period 1 (Day 1)
COMPLETED
|
0
|
0
|
7
|
7
|
6
|
|
Part 2 Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 Period 2 (Day 1)
STARTED
|
0
|
0
|
7
|
7
|
6
|
|
Part 2 Period 2 (Day 1)
COMPLETED
|
0
|
0
|
7
|
7
|
5
|
|
Part 2 Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 Period 3 (Up to Day 5)
STARTED
|
0
|
0
|
7
|
7
|
5
|
|
Part 2 Period 3 (Up to Day 5)
COMPLETED
|
0
|
0
|
7
|
7
|
5
|
|
Part 2 Period 3 (Up to Day 5)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: Treatment Sequence AB
Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 1: Treatment Sequence BA
Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence CDE
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence DEC
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence ECD
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
|---|---|---|---|---|---|
|
Part 2 Period 1 (Day 1)
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 Period 2 (Day 1)
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1: Treatment Sequence AB
n=9 Participants
Participants were administered a single dose of GSK3640254 200 milligram (mg) capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg tablets (Treatment B- test), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 1: Treatment Sequence BA
n=9 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets (Treatment B-test), orally under moderate fat conditions on Day 1 in Period 1, followed by GSK3640254 200 mg capsules (Treatment A-reference), orally under moderate fat conditions on Day 1 in Period 2. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence CDE
n=7 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence DEC
n=7 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 1, followed by GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 2, followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
Part 2: Treatment Sequence ECD
n=7 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions (Treatment E-test) on Day 1 in Period 1; followed by GSK3640254 200 mg tablets, orally under moderate fat conditions (Treatment C-test) on Day 1 in Period 2; followed by GSK3640254 200 mg tablets, orally under fasted conditions (Treatment D-reference) on Day 1 in Period 3. There was a wash out period of at least 7 days between each dose of study intervention.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
19 to 64 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population comprised of all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) for GSK3640254-Part 1
|
36.94 Hours*microgram per milliliter
Geometric Coefficient of Variation 42.7
|
36.88 Hours*microgram per milliliter
Geometric Coefficient of Variation 40.3
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Time t (AUC[0 to t]) for GSK3640254-Part 1
|
33.72 Hours*microgram per milliliter
Geometric Coefficient of Variation 41.1
|
33.80 Hours*microgram per milliliter
Geometric Coefficient of Variation 40.2
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) for GSK3640254-Part 1
|
1.201 Microgram per milliliter
Geometric Coefficient of Variation 33.4
|
1.313 Microgram per milliliter
Geometric Coefficient of Variation 45.3
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Time of Maximum Observed Concentration for GSK3640254-Part 1
|
5.000 Hours
Interval 3.0 to 12.0
|
4.000 Hours
Interval 2.5 to 6.0
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=10 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
AUC(0 to Inf) for GSK3640254-Part 2
|
41.00 Hours*micrograms per milliliter
Geometric Coefficient of Variation 42.2
|
13.46 Hours*micrograms per milliliter
Geometric Coefficient of Variation 58.2
|
36.92 Hours*micrograms per milliliter
Geometric Coefficient of Variation 35.9
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=13 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
AUC(0 to t) for GSK3640254-Part 2
|
37.91 Hours*micrograms per milliliter
Geometric Coefficient of Variation 41.5
|
11.37 Hours*micrograms per milliliter
Geometric Coefficient of Variation 65.6
|
34.08 Hours*micrograms per milliliter
Geometric Coefficient of Variation 34.9
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=13 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Cmax for GSK3640254-Part 2
|
1.425 Micrograms per milliliter
Geometric Coefficient of Variation 35.6
|
0.3544 Micrograms per milliliter
Geometric Coefficient of Variation 84.4
|
1.082 Micrograms per milliliter
Geometric Coefficient of Variation 38.6
|
PRIMARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=13 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Time of Maximum Observed Concentration for GSK3640254-Part 2
|
5.000 Hours
Interval 2.0 to 8.0
|
4.000 Hours
Interval 2.03 to 24.0
|
5.000 Hours
Interval 1.5 to 12.0
|
SECONDARY outcome
Timeframe: Up to Day 12Population: Safety Population comprised of all participants who received at least 1 dose of study medication.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1
AEs
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1
SAEs
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Day 19Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Number of Participants With AEs and SAEs-Part 2
AEs
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With AEs and SAEs-Part 2
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Eosinophils; Day 5; n=9, 9
|
0.133 10^9 cells per liter
Standard Deviation 0.1227
|
0.118 10^9 cells per liter
Standard Deviation 0.0769
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Basophils; Baseline; n=18, 18
|
0.032 10^9 cells per liter
Standard Deviation 0.0134
|
0.032 10^9 cells per liter
Standard Deviation 0.0134
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Basophils; Day 2; n=18, 18
|
0.030 10^9 cells per liter
Standard Deviation 0.0137
|
0.030 10^9 cells per liter
Standard Deviation 0.077
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Basophils; Day 5; n=9, 9
|
0.027 10^9 cells per liter
Standard Deviation 0.0071
|
0.030 10^9 cells per liter
Standard Deviation 0.0166
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Eosinophils; Baseline; n=18, 18
|
0.100 10^9 cells per liter
Standard Deviation 0.0832
|
0.100 10^9 cells per liter
Standard Deviation 0.0832
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Eosinophils; Day 2; n=18, 18
|
0.116 10^9 cells per liter
Standard Deviation 0.0911
|
0.122 10^9 cells per liter
Standard Deviation 0.1101
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Lymphocytes; Baseline; n=18, 18
|
1.617 10^9 cells per liter
Standard Deviation 0.3975
|
1.617 10^9 cells per liter
Standard Deviation 0.3975
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Lymphocytes; Day 2; n=18, 18
|
1.726 10^9 cells per liter
Standard Deviation 0.3852
|
1.744 10^9 cells per liter
Standard Deviation 0.4791
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Lymphocytes; Day 5; n=9, 9
|
1.639 10^9 cells per liter
Standard Deviation 0.3536
|
2.074 10^9 cells per liter
Standard Deviation 0.6328
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Monocytes; Baseline; n=18, 18
|
0.403 10^9 cells per liter
Standard Deviation 0.0859
|
0.403 10^9 cells per liter
Standard Deviation 0.0859
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Monocytes; Day 2; n=18, 18
|
0.409 10^9 cells per liter
Standard Deviation 0.0955
|
0.412 10^9 cells per liter
Standard Deviation 0.1379
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Monocytes; Day 5; n=9, 9
|
0.386 10^9 cells per liter
Standard Deviation 0.1100
|
0.411 10^9 cells per liter
Standard Deviation 0.1071
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Neutrophils; Baseline; n=18, 18
|
3.406 10^9 cells per liter
Standard Deviation 1.0436
|
3.406 10^9 cells per liter
Standard Deviation 1.0436
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Neutrophils; Day 2; n=18, 18
|
2.925 10^9 cells per liter
Standard Deviation 0.6617
|
2.723 10^9 cells per liter
Standard Deviation 0.9257
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Neutrophils; Day 5; n=9, 9
|
2.864 10^9 cells per liter
Standard Deviation 0.7372
|
3.108 10^9 cells per liter
Standard Deviation 0.5724
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Platelets; Baseline; n=18, 18
|
232.5 10^9 cells per liter
Standard Deviation 43.58
|
232.5 10^9 cells per liter
Standard Deviation 43.58
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Platelets; Day 2; n=18, 18
|
238.2 10^9 cells per liter
Standard Deviation 49.37
|
241.5 10^9 cells per liter
Standard Deviation 48.56
|
—
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Platelets; Day 5; n=9, 9
|
267.1 10^9 cells per liter
Standard Deviation 52.86
|
231.4 10^9 cells per liter
Standard Deviation 38.51
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Erythrocytes Count-Part 1
Baseline; n=18, 18
|
4.801 10^12 cells per liter
Standard Deviation 0.4605
|
4.801 10^12 cells per liter
Standard Deviation 0.4605
|
—
|
|
Absolute Values for Erythrocytes Count-Part 1
Day 2; n=18, 18
|
4.937 10^12 cells per liter
Standard Deviation 0.4896
|
4.983 10^12 cells per liter
Standard Deviation 0.5010
|
—
|
|
Absolute Values for Erythrocytes Count-Part 1
Day 5; n=9, 9
|
5.009 10^12 cells per liter
Standard Deviation 0.4786
|
5.061 10^12 cells per liter
Standard Deviation 0.3888
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hemoglobin.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Hemoglobin-Part 1
Day 5; n=9, 9
|
150.3 Grams per liter
Standard Deviation 15.74
|
150.3 Grams per liter
Standard Deviation 13.13
|
—
|
|
Absolute Values for Hemoglobin-Part 1
Baseline; n=18, 18
|
142.2 Grams per liter
Standard Deviation 13.46
|
142.2 Grams per liter
Standard Deviation 13.46
|
—
|
|
Absolute Values for Hemoglobin-Part 1
Day 2; n=18, 18
|
146.4 Grams per liter
Standard Deviation 13.74
|
148.3 Grams per liter
Standard Deviation 14.29
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hematocrit.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Hematocrit-Part 1
Baseline; n=18, 18
|
0.4252 Proportion of red blood cells in blood
Standard Deviation 0.03485
|
0.4252 Proportion of red blood cells in blood
Standard Deviation 0.03485
|
—
|
|
Absolute Values for Hematocrit-Part 1
Day 2; n=18, 18
|
0.4346 Proportion of red blood cells in blood
Standard Deviation 0.03935
|
0.4405 Proportion of red blood cells in blood
Standard Deviation 0.03885
|
—
|
|
Absolute Values for Hematocrit-Part 1
Day 5; n=9, 9
|
0.4410 Proportion of red blood cells in blood
Standard Deviation 0.04004
|
0.4430 Proportion of red blood cells in blood
Standard Deviation 0.03266
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1
Baseline; n=18, 18
|
88.80 Femtoliters
Standard Deviation 4.887
|
88.80 Femtoliters
Standard Deviation 4.887
|
—
|
|
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1
Day 2; n=18, 18
|
88.21 Femtoliters
Standard Deviation 4.480
|
88.61 Femtoliters
Standard Deviation 4.363
|
—
|
|
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 1
Day 5; n=9, 9
|
88.17 Femtoliters
Standard Deviation 4.532
|
87.63 Femtoliters
Standard Deviation 4.971
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Baseline; n=18, 18
|
29.68 Picograms
Standard Deviation 1.858
|
29.68 Picograms
Standard Deviation 1.858
|
—
|
|
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Day 2; n=18, 18
|
29.69 Picograms
Standard Deviation 1.740
|
29.83 Picograms
Standard Deviation 1.772
|
—
|
|
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Day 5; n=9, 9
|
30.08 Picograms
Standard Deviation 1.737
|
29.74 Picograms
Standard Deviation 1.938
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Lymphocytes; Day 5; n=7, 5, 7
|
1.806 10^9 cells per liter
Standard Deviation 0.3577
|
1.472 10^9 cells per liter
Standard Deviation 0.2765
|
1.923 10^9 cells per liter
Standard Deviation 0.4442
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Monocytes; Baseline; n=20, 19, 21
|
0.469 10^9 cells per liter
Standard Deviation 0.1445
|
0.469 10^9 cells per liter
Standard Deviation 0.1445
|
0.469 10^9 cells per liter
Standard Deviation 0.1445
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Monocytes; Day 2; n=20, 19, 21
|
0.446 10^9 cells per liter
Standard Deviation 0.1589
|
0.449 10^9 cells per liter
Standard Deviation 0.1171
|
0.446 10^9 cells per liter
Standard Deviation 0.1553
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Monocytes; Day 5; n=7, 5, 7
|
0.530 10^9 cells per liter
Standard Deviation 0.1788
|
0.422 10^9 cells per liter
Standard Deviation 0.0669
|
0.504 10^9 cells per liter
Standard Deviation 0.1130
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Basophils; Baseline; n=20, 19, 21
|
0.042 10^9 cells per liter
Standard Deviation 0.0260
|
0.042 10^9 cells per liter
Standard Deviation 0.0260
|
0.042 10^9 cells per liter
Standard Deviation 0.0260
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Basophils; Day 2; n=20, 19, 21
|
0.041 10^9 cells per liter
Standard Deviation 0.0276
|
0.040 10^9 cells per liter
Standard Deviation 0.0200
|
0.043 10^9 cells per liter
Standard Deviation 0.0215
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Basophils; Day 5; n=7, 5, 7
|
0.047 10^9 cells per liter
Standard Deviation 0.0287
|
0.036 10^9 cells per liter
Standard Deviation 0.0167
|
0.049 10^9 cells per liter
Standard Deviation 0.0219
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Eosinophils; Baseline; n=20, 19, 21
|
0.141 10^9 cells per liter
Standard Deviation 0.0879
|
0.141 10^9 cells per liter
Standard Deviation 0.0879
|
0.141 10^9 cells per liter
Standard Deviation 0.0879
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Eosinophils; Day 2; n=20, 19, 21
|
0.136 10^9 cells per liter
Standard Deviation 0.0922
|
0.135 10^9 cells per liter
Standard Deviation 0.0837
|
0.150 10^9 cells per liter
Standard Deviation 0.1109
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Eosinophils; Day 5; n=7, 5, 7
|
0.146 10^9 cells per liter
Standard Deviation 0.1050
|
0.090 10^9 cells per liter
Standard Deviation 0.0374
|
0.151 10^9 cells per liter
Standard Deviation 0.0915
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Lymphocytes; Baseline; n=20, 19, 21
|
1.650 10^9 cells per liter
Standard Deviation 0.4926
|
1.650 10^9 cells per liter
Standard Deviation 0.4926
|
1.650 10^9 cells per liter
Standard Deviation 0.4926
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Lymphocytes; Day 2; n=20, 19, 21
|
1.576 10^9 cells per liter
Standard Deviation 0.3410
|
1.684 10^9 cells per liter
Standard Deviation 0.4939
|
1.583 10^9 cells per liter
Standard Deviation 0.3748
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Neutrophils; Baseline; n=20, 19, 21
|
3.246 10^9 cells per liter
Standard Deviation 1.0719
|
3.246 10^9 cells per liter
Standard Deviation 1.0719
|
3.246 10^9 cells per liter
Standard Deviation 1.0719
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Neutrophils; Day 2; n=20, 19, 21
|
2.908 10^9 cells per liter
Standard Deviation 1.1660
|
2.904 10^9 cells per liter
Standard Deviation 0.8595
|
2.947 10^9 cells per liter
Standard Deviation 1.0824
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Neutrophils; Day 5; n=7, 5, 7
|
2.464 10^9 cells per liter
Standard Deviation 0.9204
|
3.472 10^9 cells per liter
Standard Deviation 0.8987
|
3.877 10^9 cells per liter
Standard Deviation 1.4452
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Platelets; Baseline; n=20, 19, 21
|
259.9 10^9 cells per liter
Standard Deviation 63.91
|
259.9 10^9 cells per liter
Standard Deviation 63.91
|
259.9 10^9 cells per liter
Standard Deviation 63.91
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Platelets; Day 2; n=20, 19, 21
|
284.2 10^9 cells per liter
Standard Deviation 55.70
|
270.6 10^9 cells per liter
Standard Deviation 60.80
|
281.3 10^9 cells per liter
Standard Deviation 59.88
|
|
Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Platelets; Day 5; n=7, 5, 7
|
255.9 10^9 cells per liter
Standard Deviation 47.27
|
272.4 10^9 cells per liter
Standard Deviation 77.61
|
291.3 10^9 cells per liter
Standard Deviation 48.52
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Erythrocytes Count-Part 2
Baseline; n=20, 19, 21
|
4.613 10^12 cells per liter
Standard Deviation 0.5680
|
4.613 10^12 cells per liter
Standard Deviation 0.5680
|
4.613 10^12 cells per liter
Standard Deviation 0.5680
|
|
Absolute Values for Erythrocytes Count-Part 2
Day 2; n=20, 19, 21
|
4.893 10^12 cells per liter
Standard Deviation 0.5814
|
4.899 10^12 cells per liter
Standard Deviation 0.5878
|
4.850 10^12 cells per liter
Standard Deviation 0.5900
|
|
Absolute Values for Erythrocytes Count-Part 2
Day 5; n=7, 5, 7
|
4.941 10^12 cells per liter
Standard Deviation 0.6086
|
4.424 10^12 cells per liter
Standard Deviation 0.6683
|
4.957 10^12 cells per liter
Standard Deviation 0.6309
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hemoglobin.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Hemoglobin-Part 2
Baseline; n=20, 19, 21
|
134.0 Grams per liter
Standard Deviation 15.37
|
134.0 Grams per liter
Standard Deviation 15.37
|
134.0 Grams per liter
Standard Deviation 15.37
|
|
Absolute Values for Hemoglobin-Part 2
Day 2; n=20, 19, 21
|
140.6 Grams per liter
Standard Deviation 15.83
|
141.1 Grams per liter
Standard Deviation 16.19
|
140.0 Grams per liter
Standard Deviation 15.37
|
|
Absolute Values for Hemoglobin-Part 2
Day 5; n=7, 5, 7
|
146.9 Grams per liter
Standard Deviation 14.14
|
124.2 Grams per liter
Standard Deviation 15.74
|
142.7 Grams per liter
Standard Deviation 14.42
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hematocrit.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Hematocrit-Part 2
Baseline; n=20, 19, 21
|
0.4010 Proportion of red blood cells in blood
Standard Deviation 0.03876
|
0.4010 Proportion of red blood cells in blood
Standard Deviation 0.03876
|
0.4010 Proportion of red blood cells in blood
Standard Deviation 0.03876
|
|
Absolute Values for Hematocrit-Part 2
Day 2; n=20, 19, 21
|
0.4207 Proportion of red blood cells in blood
Standard Deviation 0.03989
|
0.4219 Proportion of red blood cells in blood
Standard Deviation 0.04146
|
0.4176 Proportion of red blood cells in blood
Standard Deviation 0.03777
|
|
Absolute Values for Hematocrit-Part 2
Day 5; n=7, 5, 7
|
0.4337 Proportion of red blood cells in blood
Standard Deviation 0.03499
|
0.3786 Proportion of red blood cells in blood
Standard Deviation 0.04858
|
0.4216 Proportion of red blood cells in blood
Standard Deviation 0.03917
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2
Baseline; n=20, 19, 21
|
86.98 Femtoliters
Standard Deviation 5.931
|
86.98 Femtoliters
Standard Deviation 5.931
|
86.98 Femtoliters
Standard Deviation 5.931
|
|
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2
Day 2; n=20, 19, 21
|
86.37 Femtoliters
Standard Deviation 5.934
|
86.52 Femtoliters
Standard Deviation 6.038
|
86.57 Femtoliters
Standard Deviation 5.867
|
|
Absolute Values for Erythrocyte Mean Corpuscular Volume-Part 2
Day 5; n=7, 5, 7
|
88.47 Femtoliters
Standard Deviation 8.285
|
85.86 Femtoliters
Standard Deviation 4.453
|
85.41 Femtoliters
Standard Deviation 4.401
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Baseline; n=20, 19, 21
|
29.05 Picograms
Standard Deviation 2.499
|
29.05 Picograms
Standard Deviation 2.499
|
29.05 Picograms
Standard Deviation 2.499
|
|
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Day 2; n=20, 19, 21
|
28.87 Picograms
Standard Deviation 2.415
|
28.92 Picograms
Standard Deviation 2.449
|
28.99 Picograms
Standard Deviation 2.411
|
|
Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Day 5; n=7, 5, 7
|
29.96 Picograms
Standard Deviation 3.365
|
28.14 Picograms
Standard Deviation 1.394
|
28.93 Picograms
Standard Deviation 1.962
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Basophils; Day 2; n=18, 18
|
-0.002 10^9 cells per liter
Standard Deviation 0.0092
|
-0.002 10^9 cells per liter
Standard Deviation 0.0092
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Basophils; Day 5; n=9, 9
|
-0.002 10^9 cells per liter
Standard Deviation 0.0083
|
-0.004 10^9 cells per liter
Standard Deviation 0.0073
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Eosinophils; Day 2; n=18, 18
|
0.016 10^9 cells per liter
Standard Deviation 0.0322
|
0.022 10^9 cells per liter
Standard Deviation 0.0387
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Eosinophils; Day 5; n=9, 9
|
0.022 10^9 cells per liter
Standard Deviation 0.0441
|
0.029 10^9 cells per liter
Standard Deviation 0.0462
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Lymphocytes; Day 2; n=18, 18
|
0.109 10^9 cells per liter
Standard Deviation 0.2237
|
0.127 10^9 cells per liter
Standard Deviation 0.2350
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Lymphocytes; Day 5; n=9, 9
|
0.082 10^9 cells per liter
Standard Deviation 0.2124
|
0.398 10^9 cells per liter
Standard Deviation 0.3721
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Monocytes; Day 2; n=18, 18
|
0.006 10^9 cells per liter
Standard Deviation 0.0581
|
0.008 10^9 cells per liter
Standard Deviation 0.1164
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Monocytes; Day 5; n=9, 9
|
-0.009 10^9 cells per liter
Standard Deviation 0.0821
|
-0.001 10^9 cells per liter
Standard Deviation 0.0637
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Neutrophils; Day 2; n=18, 18
|
-0.481 10^9 cells per liter
Standard Deviation 0.7029
|
-0.683 10^9 cells per liter
Standard Deviation 0.8597
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Neutrophils; Day 5; n=9, 9
|
-0.291 10^9 cells per liter
Standard Deviation 0.5628
|
0.549 10^9 cells per liter
Standard Deviation 0.7398
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Platelets; Day 2; n=18, 18
|
5.7 10^9 cells per liter
Standard Deviation 21.18
|
9.0 10^9 cells per liter
Standard Deviation 18.89
|
—
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 1
Platelets; Day 5; n=9, 9
|
20.8 10^9 cells per liter
Standard Deviation 15.16
|
12.8 10^9 cells per liter
Standard Deviation 22.55
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Erythrocytes Count-Part 1
Day 5; n=9, 9
|
0.253 10^12 cells per liter
Standard Deviation 0.2320
|
0.214 10^12 cells per liter
Standard Deviation 0.1729
|
—
|
|
Change From Baseline in Erythrocytes Count-Part 1
Day 2; n=18, 18
|
0.136 10^12 cells per liter
Standard Deviation 0.2431
|
0.182 10^12 cells per liter
Standard Deviation 0.2052
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin-Part 1
Day 2; n=18, 18
|
4.2 Grams per liter
Standard Deviation 7.11
|
6.1 Grams per liter
Standard Deviation 6.69
|
—
|
|
Change From Baseline in Hemoglobin-Part 1
Day 5; n=9, 9
|
8.7 Grams per liter
Standard Deviation 7.66
|
7.6 Grams per liter
Standard Deviation 6.04
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Hematocrit-Part 1
Day 5; n=9, 9
|
0.0189 Proportion of red blood cells in blood
Standard Deviation 0.02196
|
0.0147 Proportion of red blood cells in blood
Standard Deviation 0.01362
|
—
|
|
Change From Baseline in Hematocrit-Part 1
Day 2; n=18, 18
|
0.0094 Proportion of red blood cells in blood
Standard Deviation 0.02265
|
0.0153 Proportion of red blood cells in blood
Standard Deviation 0.01912
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1
Day 2; n=18, 18
|
-0.59 Femtoliters
Standard Deviation 0.984
|
-0.19 Femtoliters
Standard Deviation 1.050
|
—
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 1
Day 5; n=9, 9
|
-0.84 Femtoliters
Standard Deviation 0.911
|
-0.96 Femtoliters
Standard Deviation 0.592
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Day 2; n=18, 18
|
0.01 Picograms
Standard Deviation 0.344
|
0.14 Picograms
Standard Deviation 0.365
|
—
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 1
Day 5; n=9, 9
|
0.26 Picograms
Standard Deviation 0.343
|
0.20 Picograms
Standard Deviation 0.439
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Eosinophils; Day 5; n=7, 5, 7
|
0.007 10^9 cells per liter
Standard Deviation 0.0423
|
-0.030 10^9 cells per liter
Standard Deviation 0.0738
|
-0.009 10^9 cells per liter
Standard Deviation 0.0402
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Lymphocytes; Day 2; n=20, 19, 21
|
-0.073 10^9 cells per liter
Standard Deviation 0.2828
|
0.006 10^9 cells per liter
Standard Deviation 0.3097
|
-0.068 10^9 cells per liter
Standard Deviation 0.2313
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Basophils; Day 2; n=20, 19, 21
|
-0.001 10^9 cells per liter
Standard Deviation 0.0107
|
-0.003 10^9 cells per liter
Standard Deviation 0.0129
|
0.001 10^9 cells per liter
Standard Deviation 0.0128
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Basophils; Day 5; n=7, 5, 7
|
0.000 10^9 cells per liter
Standard Deviation 0.0100
|
0.006 10^9 cells per liter
Standard Deviation 0.0114
|
0.000 10^9 cells per liter
Standard Deviation 0.0129
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Eosinophils; Day 2; n=20, 19, 21
|
0.001 10^9 cells per liter
Standard Deviation 0.0424
|
-0.006 10^9 cells per liter
Standard Deviation 0.0519
|
0.009 10^9 cells per liter
Standard Deviation 0.0464
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Lymphocytes; Day 5; n=7, 5, 7
|
0.257 10^9 cells per liter
Standard Deviation 0.2146
|
-0.010 10^9 cells per liter
Standard Deviation 0.1454
|
-0.024 10^9 cells per liter
Standard Deviation 0.4172
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Monocytes; Day 2; n=20, 19, 21
|
-0.028 10^9 cells per liter
Standard Deviation 0.1055
|
-0.022 10^9 cells per liter
Standard Deviation 0.0978
|
-0.022 10^9 cells per liter
Standard Deviation 0.1272
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Monocytes; Day 5; n=7, 5, 7
|
0.024 10^9 cells per liter
Standard Deviation 0.1081
|
0.000 10^9 cells per liter
Standard Deviation 0.1058
|
0.034 10^9 cells per liter
Standard Deviation 0.1509
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Neutrophils; Day 2; n=20, 19, 21
|
-0.326 10^9 cells per liter
Standard Deviation 0.7627
|
-0.336 10^9 cells per liter
Standard Deviation 0.7377
|
-0.300 10^9 cells per liter
Standard Deviation 0.7173
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Neutrophils; Day 5; n=7, 5, 7
|
-0.216 10^9 cells per liter
Standard Deviation 0.6986
|
0.154 10^9 cells per liter
Standard Deviation 0.8131
|
0.134 10^9 cells per liter
Standard Deviation 1.1111
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Platelets; Day 2; n=20, 19, 21
|
21.6 10^9 cells per liter
Standard Deviation 30.53
|
9.4 10^9 cells per liter
Standard Deviation 25.64
|
21.4 10^9 cells per liter
Standard Deviation 26.82
|
|
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets-Part 2
Platelets; Day 5; n=7, 5, 7
|
38.0 10^9 cells per liter
Standard Deviation 26.03
|
-5.8 10^9 cells per liter
Standard Deviation 28.08
|
-1.1 10^9 cells per liter
Standard Deviation 30.28
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Erythrocytes Count-Part 2
Day 2; n=20, 19, 21
|
0.256 10^12 cells per liter
Standard Deviation 0.1751
|
0.247 10^12 cells per liter
Standard Deviation 0.2564
|
0.237 10^12 cells per liter
Standard Deviation 0.1682
|
|
Change From Baseline in Erythrocytes Count-Part 2
Day 5; n=7, 5, 7
|
0.231 10^12 cells per liter
Standard Deviation 0.1520
|
0.172 10^12 cells per liter
Standard Deviation 0.1678
|
0.077 10^12 cells per liter
Standard Deviation 0.2276
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin-Part 2
Day 2; n=20, 19, 21
|
6.5 Grams per liter
Standard Deviation 4.96
|
6.3 Grams per liter
Standard Deviation 7.39
|
6.0 Grams per liter
Standard Deviation 4.21
|
|
Change From Baseline in Hemoglobin-Part 2
Day 5; n=7, 5, 7
|
7.0 Grams per liter
Standard Deviation 3.11
|
4.2 Grams per liter
Standard Deviation 5.50
|
2.4 Grams per liter
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Hematocrit-Part 2
Day 5; n=7, 5, 7
|
0.0179 Proportion of red blood cells in blood
Standard Deviation 0.01378
|
0.0106 Proportion of red blood cells in blood
Standard Deviation 0.01731
|
0.0046 Proportion of red blood cells in blood
Standard Deviation 0.01855
|
|
Change From Baseline in Hematocrit-Part 2
Day 2; n=20, 19, 21
|
0.0187 Proportion of red blood cells in blood
Standard Deviation 0.01477
|
0.0182 Proportion of red blood cells in blood
Standard Deviation 0.02179
|
0.0166 Proportion of red blood cells in blood
Standard Deviation 0.01313
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular volume. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2
Day 2; n=20, 19, 21
|
-0.35 Femtoliters
Standard Deviation 0.841
|
-0.28 Femtoliters
Standard Deviation 0.897
|
-0.41 Femtoliters
Standard Deviation 0.774
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Volume-Part 2
Day 5; n=7, 5, 7
|
-0.06 Femtoliters
Standard Deviation 1.124
|
-0.02 Femtoliters
Standard Deviation 1.103
|
-0.33 Femtoliters
Standard Deviation 0.834
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following hematology parameter: erythrocyte mean corpuscular hemoglobin. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Day 2; n=20, 19, 21
|
-0.05 Picograms
Standard Deviation 0.330
|
-0.05 Picograms
Standard Deviation 0.276
|
-0.06 Picograms
Standard Deviation 0.356
|
|
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin-Part 2
Day 5; n=7, 5, 7
|
0.10 Picograms
Standard Deviation 0.365
|
0.18 Picograms
Standard Deviation 0.536
|
0.13 Picograms
Standard Deviation 0.553
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Creatinine; Baseline; n=18, 18
|
78.68 Micromoles per liter
Standard Deviation 15.983
|
78.68 Micromoles per liter
Standard Deviation 15.983
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Creatinine; Day 2; n=18, 18
|
80.87 Micromoles per liter
Standard Deviation 15.104
|
80.11 Micromoles per liter
Standard Deviation 14.243
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Creatinine; Day 5; n=9, 9
|
79.57 Micromoles per liter
Standard Deviation 17.196
|
80.33 Micromoles per liter
Standard Deviation 11.925
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Total bilirubin; Baseline; n=18, 18
|
10.56 Micromoles per liter
Standard Deviation 3.578
|
10.56 Micromoles per liter
Standard Deviation 3.578
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Total bilirubin; Day 2; n=18, 18
|
11.45 Micromoles per liter
Standard Deviation 4.334
|
10.91 Micromoles per liter
Standard Deviation 2.952
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Total bilirubin; Day 5; n=9, 9
|
11.49 Micromoles per liter
Standard Deviation 1.590
|
11.41 Micromoles per liter
Standard Deviation 3.867
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Direct bilirubin; Baseline; n=18, 18
|
1.96 Micromoles per liter
Standard Deviation 0.624
|
1.96 Micromoles per liter
Standard Deviation 0.624
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Direct bilirubin; Day 2; n=18, 18
|
1.91 Micromoles per liter
Standard Deviation 0.643
|
1.86 Micromoles per liter
Standard Deviation 0.631
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Direct bilirubin; Day 5; n=9, 9
|
1.86 Micromoles per liter
Standard Deviation 0.332
|
1.90 Micromoles per liter
Standard Deviation 0.752
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Urate; Baseline; n=18, 18
|
306.7 Micromoles per liter
Standard Deviation 87.16
|
306.7 Micromoles per liter
Standard Deviation 87.16
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Urate; Day 2; n=18, 18
|
283.2 Micromoles per liter
Standard Deviation 78.74
|
282.5 Micromoles per liter
Standard Deviation 68.93
|
—
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Urate; Day 5; n=9, 9
|
281.4 Micromoles per liter
Standard Deviation 75.17
|
282.9 Micromoles per liter
Standard Deviation 67.35
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
BUN; Baseline; n=18, 18
|
3.728 Millimoles per liter
Standard Deviation 1.0672
|
3.728 Millimoles per liter
Standard Deviation 1.0672
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Triglycerides; Day 2; n=18, 18
|
1.127 Millimoles per liter
Standard Deviation 0.3973
|
1.036 Millimoles per liter
Standard Deviation 0.3982
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Cholesterol; Baseline; n=18, 18
|
4.549 Millimoles per liter
Standard Deviation 0.9656
|
4.549 Millimoles per liter
Standard Deviation 0.9656
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Carbon dioxide; Day 2; n=18, 18
|
30.1 Millimoles per liter
Standard Deviation 1.86
|
30.2 Millimoles per liter
Standard Deviation 1.58
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Calcium; Baseline; n=18, 18
|
2.327 Millimoles per liter
Standard Deviation 0.0451
|
2.327 Millimoles per liter
Standard Deviation 0.0451
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Calcium; Day 2; n=18, 18
|
2.352 Millimoles per liter
Standard Deviation 0.0536
|
2.378 Millimoles per liter
Standard Deviation 0.0830
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Calcium; Day 5; n=9, 9
|
2.343 Millimoles per liter
Standard Deviation 0.0705
|
2.313 Millimoles per liter
Standard Deviation 0.0559
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Glucose; Baseline; n=18, 18
|
4.987 Millimoles per liter
Standard Deviation 0.3833
|
4.987 Millimoles per liter
Standard Deviation 0.3833
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Glucose; Day 2; n=18, 18
|
4.842 Millimoles per liter
Standard Deviation 0.3451
|
4.706 Millimoles per liter
Standard Deviation 0.2996
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Glucose; Day 5; n=9, 9
|
4.607 Millimoles per liter
Standard Deviation 0.2889
|
4.600 Millimoles per liter
Standard Deviation 0.2182
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Potassium; Baseline; n=18, 18
|
4.00 Millimoles per liter
Standard Deviation 0.230
|
4.00 Millimoles per liter
Standard Deviation 0.230
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Potassium; Day 2; n=18, 18
|
4.27 Millimoles per liter
Standard Deviation 0.256
|
4.33 Millimoles per liter
Standard Deviation 0.379
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Potassium; Day 5; n=9, 9
|
4.18 Millimoles per liter
Standard Deviation 0.228
|
4.13 Millimoles per liter
Standard Deviation 0.320
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Sodium; Baseline; n=18, 18
|
136.9 Millimoles per liter
Standard Deviation 2.19
|
136.9 Millimoles per liter
Standard Deviation 2.19
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Sodium; Day 2; n=18, 18
|
138.5 Millimoles per liter
Standard Deviation 1.54
|
138.9 Millimoles per liter
Standard Deviation 1.75
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Sodium; Day 5; n=9, 9
|
138.2 Millimoles per liter
Standard Deviation 1.48
|
138.8 Millimoles per liter
Standard Deviation 1.48
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Chloride; Baseline; n=18, 18
|
102.3 Millimoles per liter
Standard Deviation 1.64
|
102.3 Millimoles per liter
Standard Deviation 1.64
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Chloride; Day 2; n=18, 18
|
102.5 Millimoles per liter
Standard Deviation 1.69
|
102.9 Millimoles per liter
Standard Deviation 1.66
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Chloride; Day 5; n=9, 9
|
101.9 Millimoles per liter
Standard Deviation 1.76
|
101.8 Millimoles per liter
Standard Deviation 1.56
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Phosphate; Baseline; n=18, 18
|
1.121 Millimoles per liter
Standard Deviation 0.1289
|
1.121 Millimoles per liter
Standard Deviation 0.1289
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Phosphate; Day 2; n=18, 18
|
1.197 Millimoles per liter
Standard Deviation 0.1058
|
1.197 Millimoles per liter
Standard Deviation 0.1365
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Phosphate; Day 5; n=9, 9
|
1.173 Millimoles per liter
Standard Deviation 0.1413
|
1.234 Millimoles per liter
Standard Deviation 0.0963
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
BUN; Day 2; n=18, 18
|
4.747 Millimoles per liter
Standard Deviation 0.8949
|
4.654 Millimoles per liter
Standard Deviation 0.8997
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
BUN; Day 5; n=9, 9
|
5.053 Millimoles per liter
Standard Deviation 0.9143
|
4.729 Millimoles per liter
Standard Deviation 0.7928
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Triglycerides; Baseline; n=18, 18
|
1.026 Millimoles per liter
Standard Deviation 0.6064
|
1.026 Millimoles per liter
Standard Deviation 0.6064
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Triglycerides; Day 5; n=9, 9
|
1.029 Millimoles per liter
Standard Deviation 0.3389
|
0.904 Millimoles per liter
Standard Deviation 0.2605
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Cholesterol; Day 2; n=18, 18
|
4.544 Millimoles per liter
Standard Deviation 0.8853
|
4.632 Millimoles per liter
Standard Deviation 0.9164
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Cholesterol; Day 5; n=9, 9
|
4.519 Millimoles per liter
Standard Deviation 0.6212
|
4.330 Millimoles per liter
Standard Deviation 1.1611
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Anion gap; Baseline; n=18, 18
|
9.5 Millimoles per liter
Standard Deviation 1.76
|
9.5 Millimoles per liter
Standard Deviation 1.76
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Anion gap; Day 2; n=18, 18
|
10.1 Millimoles per liter
Standard Deviation 1.28
|
10.0 Millimoles per liter
Standard Deviation 1.08
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Anion gap; Day 5; n=9, 9
|
10.7 Millimoles per liter
Standard Deviation 0.87
|
10.1 Millimoles per liter
Standard Deviation 0.93
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Carbon dioxide; Baseline; n=18, 18
|
29.1 Millimoles per liter
Standard Deviation 2.00
|
29.1 Millimoles per liter
Standard Deviation 2.00
|
—
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, Blood Urea Nitrogen (BUN), Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Carbon dioxide; Day 5; n=9, 9
|
29.9 Millimoles per liter
Standard Deviation 1.36
|
31.0 Millimoles per liter
Standard Deviation 1.87
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
ALT; Baseline; n=18, 18
|
22.1 International units per liter
Standard Deviation 12.44
|
22.1 International units per liter
Standard Deviation 12.44
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
ALT; Day 2; n=18, 18
|
21.8 International units per liter
Standard Deviation 13.38
|
18.4 International units per liter
Standard Deviation 9.28
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
ALT; Day 5; n=9, 9
|
20.6 International units per liter
Standard Deviation 14.51
|
19.6 International units per liter
Standard Deviation 7.07
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
ALP; Baseline; n=18, 18
|
54.6 International units per liter
Standard Deviation 11.32
|
54.6 International units per liter
Standard Deviation 11.32
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
ALP; Day 2; n=18, 18
|
52.1 International units per liter
Standard Deviation 11.59
|
52.1 International units per liter
Standard Deviation 10.96
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
ALP; Day 5; n=9, 9
|
55.2 International units per liter
Standard Deviation 12.34
|
50.3 International units per liter
Standard Deviation 5.87
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
AST; Baseline; n=18, 18
|
21.7 International units per liter
Standard Deviation 8.39
|
21.7 International units per liter
Standard Deviation 8.39
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
AST; Day 2; n=18, 18
|
19.1 International units per liter
Standard Deviation 6.65
|
17.6 International units per liter
Standard Deviation 4.94
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
AST; Day 5; n=9, 9
|
19.0 International units per liter
Standard Deviation 4.30
|
17.0 International units per liter
Standard Deviation 3.71
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
GGT; Baseline; n=18, 18
|
19.3 International units per liter
Standard Deviation 11.26
|
19.3 International units per liter
Standard Deviation 11.26
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
GGT; Day 2; n=18, 18
|
18.1 International units per liter
Standard Deviation 11.18
|
18.9 International units per liter
Standard Deviation 11.60
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
GGT; Day 5; n=9, 9
|
19.2 International units per liter
Standard Deviation 13.07
|
15.8 International units per liter
Standard Deviation 6.85
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
CK; Baseline; n=18, 18
|
126.9 International units per liter
Standard Deviation 62.61
|
126.9 International units per liter
Standard Deviation 62.61
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
CK; Day 2; n=18, 18
|
87.4 International units per liter
Standard Deviation 40.30
|
92.2 International units per liter
Standard Deviation 44.64
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
CK; Day 5; n=9, 9
|
86.0 International units per liter
Standard Deviation 35.27
|
98.3 International units per liter
Standard Deviation 50.21
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
LDH; Baseline; n=18, 18
|
136.4 International units per liter
Standard Deviation 20.82
|
136.4 International units per liter
Standard Deviation 20.82
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
LDH; Day 2; n=18, 18
|
117.7 International units per liter
Standard Deviation 21.06
|
120.4 International units per liter
Standard Deviation 21.17
|
—
|
|
Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase (CK), Lactate Dehydrogenase (LDH)-Part 1
LDH; Day 5; n=9, 9
|
122.0 International units per liter
Standard Deviation 20.91
|
123.6 International units per liter
Standard Deviation 18.53
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Albumin; Baseline; n=18, 18
|
43.7 Grams per liter
Standard Deviation 2.52
|
43.7 Grams per liter
Standard Deviation 2.52
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Albumin; Day 2; n=18, 18
|
43.8 Grams per liter
Standard Deviation 2.53
|
44.4 Grams per liter
Standard Deviation 2.96
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Albumin; Day 5; n=9, 9
|
45.1 Grams per liter
Standard Deviation 2.85
|
44.2 Grams per liter
Standard Deviation 2.82
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Globulin; Baseline; n=18, 18
|
27.5 Grams per liter
Standard Deviation 3.84
|
27.5 Grams per liter
Standard Deviation 3.84
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Globulin; Day 2; n=18, 18
|
26.9 Grams per liter
Standard Deviation 4.58
|
27.8 Grams per liter
Standard Deviation 4.35
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Globulin; Day 5; n=9, 9
|
26.2 Grams per liter
Standard Deviation 4.58
|
28.0 Grams per liter
Standard Deviation 4.97
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Protein; Baseline; n=18, 18
|
71.2 Grams per liter
Standard Deviation 3.19
|
71.2 Grams per liter
Standard Deviation 3.19
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Protein; Day 2; n=18, 18
|
70.7 Grams per liter
Standard Deviation 5.07
|
72.2 Grams per liter
Standard Deviation 5.43
|
—
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Protein; Day 5; n=9, 9
|
71.3 Grams per liter
Standard Deviation 6.42
|
72.2 Grams per liter
Standard Deviation 4.74
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Amylase; Day 5; n=9, 9
|
44.3 Units per liter
Standard Deviation 15.86
|
47.6 Units per liter
Standard Deviation 22.94
|
—
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Amylase; Baseline; n=18, 18
|
43.3 Units per liter
Standard Deviation 14.96
|
43.3 Units per liter
Standard Deviation 14.96
|
—
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Amylase; Day 2; n=18, 18
|
46.7 Units per liter
Standard Deviation 18.11
|
47.7 Units per liter
Standard Deviation 21.31
|
—
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Lipase; Baseline; n=18, 18
|
24.0 Units per liter
Standard Deviation 11.24
|
24.0 Units per liter
Standard Deviation 11.24
|
—
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Lipase; Day 2; n=18, 18
|
26.7 Units per liter
Standard Deviation 14.32
|
26.2 Units per liter
Standard Deviation 14.26
|
—
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 1
Lipase; Day 5; n=9, 9
|
28.9 Units per liter
Standard Deviation 14.98
|
24.7 Units per liter
Standard Deviation 12.66
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Creatinine; Day 2; n=20, 19, 21
|
81.95 Micromoles per liter
Standard Deviation 14.968
|
83.34 Micromoles per liter
Standard Deviation 11.078
|
80.18 Micromoles per liter
Standard Deviation 13.533
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Creatinine; Day 5; n=7, 5, 7
|
91.69 Micromoles per liter
Standard Deviation 7.992
|
76.04 Micromoles per liter
Standard Deviation 14.435
|
83.71 Micromoles per liter
Standard Deviation 15.520
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Total bilirubin; Baseline; n=20, 19, 21
|
9.05 Micromoles per liter
Standard Deviation 3.070
|
9.05 Micromoles per liter
Standard Deviation 3.070
|
9.05 Micromoles per liter
Standard Deviation 3.070
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Direct bilirubin; Baseline; n=20, 19, 21
|
1.89 Micromoles per liter
Standard Deviation 0.660
|
1.89 Micromoles per liter
Standard Deviation 0.660
|
1.89 Micromoles per liter
Standard Deviation 0.660
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Creatinine; Baseline; n=20, 19, 21
|
74.00 Micromoles per liter
Standard Deviation 13.855
|
74.00 Micromoles per liter
Standard Deviation 13.855
|
74.00 Micromoles per liter
Standard Deviation 13.855
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Total bilirubin; Day 2; n=20, 19, 21
|
11.49 Micromoles per liter
Standard Deviation 4.185
|
11.88 Micromoles per liter
Standard Deviation 4.544
|
11.11 Micromoles per liter
Standard Deviation 3.517
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Total bilirubin; Day 5; n=7, 5, 7
|
13.34 Micromoles per liter
Standard Deviation 4.999
|
14.30 Micromoles per liter
Standard Deviation 7.174
|
10.46 Micromoles per liter
Standard Deviation 1.397
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Direct bilirubin; Day 2; n=20, 19, 21
|
2.12 Micromoles per liter
Standard Deviation 0.747
|
2.17 Micromoles per liter
Standard Deviation 0.732
|
2.07 Micromoles per liter
Standard Deviation 0.656
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Direct bilirubin; Day 5; n=7, 5, 7
|
2.29 Micromoles per liter
Standard Deviation 0.760
|
2.38 Micromoles per liter
Standard Deviation 0.996
|
1.87 Micromoles per liter
Standard Deviation 0.431
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Urate; Baseline; n=20, 19, 21
|
289.2 Micromoles per liter
Standard Deviation 73.13
|
289.2 Micromoles per liter
Standard Deviation 73.13
|
289.2 Micromoles per liter
Standard Deviation 73.13
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Urate; Day 2; n=20, 19, 21
|
277.7 Micromoles per liter
Standard Deviation 72.39
|
299.4 Micromoles per liter
Standard Deviation 68.62
|
275.4 Micromoles per liter
Standard Deviation 77.75
|
|
Absolute Values for Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Urate; Day 5; n=7, 5, 7
|
286.3 Micromoles per liter
Standard Deviation 48.83
|
291.2 Micromoles per liter
Standard Deviation 96.66
|
313.6 Micromoles per liter
Standard Deviation 79.74
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Triglycerides; Day 2; n=20, 19, 21
|
0.957 Millimoles per liter
Standard Deviation 0.3872
|
0.994 Millimoles per liter
Standard Deviation 0.3875
|
0.890 Millimoles per liter
Standard Deviation 0.4024
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Calcium; Baseline; n=20, 19, 21
|
2.312 Millimoles per liter
Standard Deviation 0.0973
|
2.312 Millimoles per liter
Standard Deviation 0.0973
|
2.312 Millimoles per liter
Standard Deviation 0.0973
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Calcium; Day 2; n=20, 19, 21
|
2.408 Millimoles per liter
Standard Deviation 0.0670
|
2.369 Millimoles per liter
Standard Deviation 0.0671
|
2.390 Millimoles per liter
Standard Deviation 0.0695
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Calcium; Day 5; n=7, 5, 7
|
2.446 Millimoles per liter
Standard Deviation 0.0500
|
2.324 Millimoles per liter
Standard Deviation 0.0439
|
2.367 Millimoles per liter
Standard Deviation 0.0640
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Glucose; Baseline; n=20, 19, 21
|
4.745 Millimoles per liter
Standard Deviation 0.3160
|
4.745 Millimoles per liter
Standard Deviation 0.3160
|
4.745 Millimoles per liter
Standard Deviation 0.3160
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Glucose; Day 2; n=20, 19, 21
|
4.716 Millimoles per liter
Standard Deviation 0.2093
|
4.861 Millimoles per liter
Standard Deviation 0.2250
|
4.775 Millimoles per liter
Standard Deviation 0.2039
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Glucose; Day 5; n=7, 5, 7
|
4.574 Millimoles per liter
Standard Deviation 0.3675
|
4.608 Millimoles per liter
Standard Deviation 0.3518
|
4.926 Millimoles per liter
Standard Deviation 0.2224
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Potassium; Baseline; n=20, 19, 21
|
4.16 Millimoles per liter
Standard Deviation 0.225
|
4.16 Millimoles per liter
Standard Deviation 0.225
|
4.16 Millimoles per liter
Standard Deviation 0.225
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Potassium; Day 2; n=20, 19, 21
|
4.26 Millimoles per liter
Standard Deviation 0.244
|
4.17 Millimoles per liter
Standard Deviation 0.281
|
4.14 Millimoles per liter
Standard Deviation 0.240
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Potassium; Day 5; n=7, 5, 7
|
3.84 Millimoles per liter
Standard Deviation 0.251
|
3.94 Millimoles per liter
Standard Deviation 0.230
|
4.17 Millimoles per liter
Standard Deviation 0.236
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Sodium; Baseline; n=20, 19, 21
|
138.4 Millimoles per liter
Standard Deviation 1.56
|
138.4 Millimoles per liter
Standard Deviation 1.56
|
138.4 Millimoles per liter
Standard Deviation 1.56
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Sodium; Day 2; n=20, 19, 21
|
137.9 Millimoles per liter
Standard Deviation 2.00
|
137.9 Millimoles per liter
Standard Deviation 2.58
|
137.4 Millimoles per liter
Standard Deviation 1.24
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Sodium; Day 5; n=7, 5, 7
|
137.3 Millimoles per liter
Standard Deviation 1.11
|
136.2 Millimoles per liter
Standard Deviation 2.59
|
136.3 Millimoles per liter
Standard Deviation 1.89
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Chloride; Baseline; n=20, 19, 21
|
102.4 Millimoles per liter
Standard Deviation 1.72
|
102.4 Millimoles per liter
Standard Deviation 1.72
|
102.4 Millimoles per liter
Standard Deviation 1.72
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Chloride; Day 2; n=20, 19, 21
|
102.0 Millimoles per liter
Standard Deviation 1.81
|
102.2 Millimoles per liter
Standard Deviation 2.06
|
102.0 Millimoles per liter
Standard Deviation 2.09
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Chloride; Day 5; n=7, 5, 7
|
100.3 Millimoles per liter
Standard Deviation 1.38
|
101.8 Millimoles per liter
Standard Deviation 2.28
|
100.4 Millimoles per liter
Standard Deviation 2.37
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Phosphate; Baseline; n=20, 19, 21
|
1.100 Millimoles per liter
Standard Deviation 0.1813
|
1.100 Millimoles per liter
Standard Deviation 0.1813
|
1.100 Millimoles per liter
Standard Deviation 0.1813
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Phosphate; Day 2; n=20, 19, 21
|
1.191 Millimoles per liter
Standard Deviation 0.1827
|
1.177 Millimoles per liter
Standard Deviation 0.1535
|
1.176 Millimoles per liter
Standard Deviation 0.1730
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Phosphate; Day 5; n=7, 5, 7
|
1.297 Millimoles per liter
Standard Deviation 0.1577
|
1.158 Millimoles per liter
Standard Deviation 0.2958
|
1.117 Millimoles per liter
Standard Deviation 0.1612
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
BUN; Baseline; n=20, 19, 21
|
4.190 Millimoles per liter
Standard Deviation 0.9187
|
4.190 Millimoles per liter
Standard Deviation 0.9187
|
4.190 Millimoles per liter
Standard Deviation 0.9187
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
BUN; Day 2; n=20, 19, 21
|
4.526 Millimoles per liter
Standard Deviation 0.7144
|
4.531 Millimoles per liter
Standard Deviation 0.8261
|
4.403 Millimoles per liter
Standard Deviation 0.8736
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
BUN; Day 5; n=7, 5, 7
|
4.921 Millimoles per liter
Standard Deviation 0.9744
|
4.768 Millimoles per liter
Standard Deviation 0.4098
|
5.050 Millimoles per liter
Standard Deviation 1.2701
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Triglycerides; Baseline; n=20, 19, 21
|
0.828 Millimoles per liter
Standard Deviation 0.3752
|
0.828 Millimoles per liter
Standard Deviation 0.3752
|
0.828 Millimoles per liter
Standard Deviation 0.3752
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Triglycerides; Day 5; n=7, 5, 7
|
0.894 Millimoles per liter
Standard Deviation 0.3072
|
0.774 Millimoles per liter
Standard Deviation 0.2790
|
1.363 Millimoles per liter
Standard Deviation 0.6417
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Cholesterol; Baseline; n=20, 19, 21
|
4.533 Millimoles per liter
Standard Deviation 0.8776
|
4.533 Millimoles per liter
Standard Deviation 0.8776
|
4.533 Millimoles per liter
Standard Deviation 0.8776
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Cholesterol; Day 2; n=20, 19, 21
|
4.652 Millimoles per liter
Standard Deviation 0.7742
|
4.639 Millimoles per liter
Standard Deviation 0.9975
|
4.610 Millimoles per liter
Standard Deviation 0.8031
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Cholesterol; Day 5; n=7, 5, 7
|
4.520 Millimoles per liter
Standard Deviation 0.5269
|
3.962 Millimoles per liter
Standard Deviation 0.8236
|
4.454 Millimoles per liter
Standard Deviation 0.8948
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Anion gap; Baseline; n=20, 19, 21
|
11.3 Millimoles per liter
Standard Deviation 1.53
|
11.3 Millimoles per liter
Standard Deviation 1.53
|
11.3 Millimoles per liter
Standard Deviation 1.53
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Anion gap; Day 2; n=20, 19, 21
|
10.6 Millimoles per liter
Standard Deviation 1.15
|
10.4 Millimoles per liter
Standard Deviation 1.17
|
10.8 Millimoles per liter
Standard Deviation 1.54
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Anion gap; Day 5; n=7, 5, 7
|
11.7 Millimoles per liter
Standard Deviation 2.43
|
10.8 Millimoles per liter
Standard Deviation 0.84
|
11.9 Millimoles per liter
Standard Deviation 1.68
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Carbon dioxide; Baseline; n=20, 19, 21
|
28.7 Millimoles per liter
Standard Deviation 2.00
|
28.7 Millimoles per liter
Standard Deviation 2.00
|
28.7 Millimoles per liter
Standard Deviation 2.00
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Carbon dioxide; Day 2; n=20, 19, 21
|
29.6 Millimoles per liter
Standard Deviation 1.67
|
29.5 Millimoles per liter
Standard Deviation 1.78
|
28.6 Millimoles per liter
Standard Deviation 2.20
|
|
Absolute Values for Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Carbon dioxide; Day 5; n=7, 5, 7
|
29.3 Millimoles per liter
Standard Deviation 1.50
|
27.6 Millimoles per liter
Standard Deviation 2.19
|
28.1 Millimoles per liter
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALP; Day 2; n=20, 19, 21
|
56.5 International units per liter
Standard Deviation 17.52
|
57.4 International units per liter
Standard Deviation 17.03
|
56.7 International units per liter
Standard Deviation 18.33
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALP; Day 5; n=7, 5, 7
|
49.6 International units per liter
Standard Deviation 22.40
|
56.4 International units per liter
Standard Deviation 9.58
|
55.0 International units per liter
Standard Deviation 13.69
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALT; Baseline; n=20, 19, 21
|
19.0 International units per liter
Standard Deviation 11.01
|
19.0 International units per liter
Standard Deviation 11.01
|
19.0 International units per liter
Standard Deviation 11.01
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALT; Day 2; n=20, 19, 21
|
14.4 International units per liter
Standard Deviation 6.06
|
17.3 International units per liter
Standard Deviation 9.49
|
16.8 International units per liter
Standard Deviation 9.20
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALT; Day 5; n=7, 5, 7
|
16.7 International units per liter
Standard Deviation 8.04
|
11.0 International units per liter
Standard Deviation 2.74
|
22.7 International units per liter
Standard Deviation 14.36
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALP; Baseline; n=20, 19, 21
|
50.4 International units per liter
Standard Deviation 16.47
|
50.4 International units per liter
Standard Deviation 16.47
|
50.4 International units per liter
Standard Deviation 16.47
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
AST; Baseline; n=20, 19, 21
|
18.0 International units per liter
Standard Deviation 6.01
|
18.0 International units per liter
Standard Deviation 6.01
|
18.0 International units per liter
Standard Deviation 6.01
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
AST; Day 2; n=20, 19, 21
|
14.9 International units per liter
Standard Deviation 3.01
|
15.8 International units per liter
Standard Deviation 4.29
|
16.0 International units per liter
Standard Deviation 4.11
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
AST; Day 5; n=7, 5, 7
|
16.7 International units per liter
Standard Deviation 4.42
|
14.0 International units per liter
Standard Deviation 2.12
|
16.6 International units per liter
Standard Deviation 3.78
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
GGT; Baseline; n=20, 19, 21
|
17.1 International units per liter
Standard Deviation 5.80
|
17.1 International units per liter
Standard Deviation 5.80
|
17.1 International units per liter
Standard Deviation 5.80
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
GGT; Day 2; n=20, 19, 21
|
16.5 International units per liter
Standard Deviation 5.56
|
17.4 International units per liter
Standard Deviation 6.15
|
17.3 International units per liter
Standard Deviation 7.67
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
GGT; Day 5; n=7, 5, 7
|
14.9 International units per liter
Standard Deviation 3.72
|
14.8 International units per liter
Standard Deviation 0.45
|
21.6 International units per liter
Standard Deviation 13.31
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
CK; Baseline; n=20, 19, 21
|
118.8 International units per liter
Standard Deviation 79.80
|
118.8 International units per liter
Standard Deviation 79.80
|
118.8 International units per liter
Standard Deviation 79.80
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
CK; Day 2; n=20, 19, 21
|
106.2 International units per liter
Standard Deviation 80.82
|
114.9 International units per liter
Standard Deviation 101.61
|
106.2 International units per liter
Standard Deviation 81.94
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
CK; Day 5; n=7, 5, 7
|
135.7 International units per liter
Standard Deviation 108.77
|
136.4 International units per liter
Standard Deviation 109.71
|
145.4 International units per liter
Standard Deviation 170.90
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
LDH; Baseline; n=20, 19, 21
|
133.6 International units per liter
Standard Deviation 19.21
|
133.6 International units per liter
Standard Deviation 19.21
|
133.6 International units per liter
Standard Deviation 19.21
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
LDH; Day 2; n=20, 19, 21
|
121.1 International units per liter
Standard Deviation 17.48
|
121.5 International units per liter
Standard Deviation 21.60
|
122.1 International units per liter
Standard Deviation 18.56
|
|
Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
LDH; Day 5; n=7, 5, 7
|
118.4 International units per liter
Standard Deviation 16.63
|
110.0 International units per liter
Standard Deviation 12.29
|
126.0 International units per liter
Standard Deviation 22.84
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Albumin; Baseline; n=20, 19, 21
|
43.8 Grams per liter
Standard Deviation 2.90
|
43.8 Grams per liter
Standard Deviation 2.90
|
43.8 Grams per liter
Standard Deviation 2.90
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Albumin; Day 2; n=20, 19, 21
|
45.6 Grams per liter
Standard Deviation 2.68
|
45.4 Grams per liter
Standard Deviation 2.27
|
45.7 Grams per liter
Standard Deviation 2.99
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Albumin; Day 5; n=7, 5, 7
|
48.0 Grams per liter
Standard Deviation 2.58
|
43.4 Grams per liter
Standard Deviation 2.07
|
45.1 Grams per liter
Standard Deviation 2.97
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Globulin; Baseline; n=20, 19, 21
|
26.5 Grams per liter
Standard Deviation 3.19
|
26.5 Grams per liter
Standard Deviation 3.19
|
26.5 Grams per liter
Standard Deviation 3.19
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Globulin; Day 2; n=20, 19, 21
|
26.6 Grams per liter
Standard Deviation 3.33
|
26.0 Grams per liter
Standard Deviation 3.43
|
26.4 Grams per liter
Standard Deviation 3.43
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Globulin; Day 5; n=7, 5, 7
|
23.6 Grams per liter
Standard Deviation 1.51
|
28.2 Grams per liter
Standard Deviation 2.49
|
26.7 Grams per liter
Standard Deviation 1.25
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Protein; Baseline; n=20, 19, 21
|
70.3 Grams per liter
Standard Deviation 4.23
|
70.3 Grams per liter
Standard Deviation 4.23
|
70.3 Grams per liter
Standard Deviation 4.23
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Protein; Day 2; n=20, 19, 21
|
72.2 Grams per liter
Standard Deviation 3.56
|
71.4 Grams per liter
Standard Deviation 3.20
|
72.1 Grams per liter
Standard Deviation 4.31
|
|
Absolute Values for Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Protein; Day 5; n=7, 5, 7
|
71.6 Grams per liter
Standard Deviation 3.15
|
71.6 Grams per liter
Standard Deviation 2.07
|
71.9 Grams per liter
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Lipase; Day 5; n=7, 5, 7
|
21.9 Units per liter
Standard Deviation 9.39
|
17.6 Units per liter
Standard Deviation 8.23
|
24.1 Units per liter
Standard Deviation 13.26
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Amylase; Baseline; n=20, 19, 21
|
49.3 Units per liter
Standard Deviation 16.33
|
49.3 Units per liter
Standard Deviation 16.33
|
49.3 Units per liter
Standard Deviation 16.33
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Amylase; Day 2; n=20, 19, 21
|
48.3 Units per liter
Standard Deviation 15.91
|
49.4 Units per liter
Standard Deviation 18.86
|
50.1 Units per liter
Standard Deviation 18.22
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Amylase; Day 5; n=7, 5, 7
|
49.6 Units per liter
Standard Deviation 22.33
|
48.8 Units per liter
Standard Deviation 8.53
|
43.6 Units per liter
Standard Deviation 14.89
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Lipase; Baseline; n=20, 19, 21
|
23.8 Units per liter
Standard Deviation 17.88
|
23.8 Units per liter
Standard Deviation 17.88
|
23.8 Units per liter
Standard Deviation 17.88
|
|
Absolute Values for Chemistry Parameters: Amylase and Lipase-Part 2
Lipase; Day 2; n=20, 19, 21
|
20.4 Units per liter
Standard Deviation 10.04
|
22.2 Units per liter
Standard Deviation 12.81
|
24.1 Units per liter
Standard Deviation 11.45
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Creatinine; Day 2; n=18, 18
|
2.19 Micromoles per liter
Standard Deviation 4.721
|
1.43 Micromoles per liter
Standard Deviation 6.188
|
—
|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Creatinine; Day 5; n=9, 9
|
3.64 Micromoles per liter
Standard Deviation 3.780
|
-1.10 Micromoles per liter
Standard Deviation 5.169
|
—
|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Total bilirubin; Day 2; n=18, 18
|
0.89 Micromoles per liter
Standard Deviation 2.659
|
0.36 Micromoles per liter
Standard Deviation 2.632
|
—
|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Total bilirubin; Day 5; n=9, 9
|
0.59 Micromoles per liter
Standard Deviation 3.297
|
1.20 Micromoles per liter
Standard Deviation 2.513
|
—
|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Direct bilirubin; Day 2; n=18, 18
|
-0.05 Micromoles per liter
Standard Deviation 0.399
|
-0.10 Micromoles per liter
Standard Deviation 0.387
|
—
|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Direct bilirubin; Day 5; n=9, 9
|
-0.12 Micromoles per liter
Standard Deviation 0.526
|
-0.04 Micromoles per liter
Standard Deviation 0.361
|
—
|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Urate; Day 2; n=18, 18
|
-23.5 Micromoles per liter
Standard Deviation 46.62
|
-24.2 Micromoles per liter
Standard Deviation 43.16
|
—
|
|
Change From Baseline Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 1
Urate; Day 5; n=9, 9
|
-29.8 Micromoles per liter
Standard Deviation 46.45
|
-19.3 Micromoles per liter
Standard Deviation 36.96
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Carbon dioxide; Day 2; n=18, 18
|
0.9 Millimoles per liter
Standard Deviation 2.60
|
1.1 Millimoles per liter
Standard Deviation 2.10
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Carbon dioxide; Day 5; n=9, 9
|
1.4 Millimoles per liter
Standard Deviation 2.60
|
1.2 Millimoles per liter
Standard Deviation 1.56
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Calcium; Day 2; n=18, 18
|
0.025 Millimoles per liter
Standard Deviation 0.0534
|
0.051 Millimoles per liter
Standard Deviation 0.0828
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Calcium; Day 5; n=9, 9
|
0.019 Millimoles per liter
Standard Deviation 0.0762
|
-0.016 Millimoles per liter
Standard Deviation 0.0548
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Glucose; Day 2; n=18, 18
|
-0.145 Millimoles per liter
Standard Deviation 0.3134
|
-0.281 Millimoles per liter
Standard Deviation 0.4796
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Glucose; Day 5; n=9, 9
|
-0.252 Millimoles per liter
Standard Deviation 0.4474
|
-0.514 Millimoles per liter
Standard Deviation 0.3475
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Potassium; Day 2; n=18, 18
|
0.27 Millimoles per liter
Standard Deviation 0.278
|
0.33 Millimoles per liter
Standard Deviation 0.331
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Potassium; Day 5; n=9, 9
|
0.30 Millimoles per liter
Standard Deviation 0.296
|
0.01 Millimoles per liter
Standard Deviation 0.247
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Sodium; Day 2; n=18, 18
|
1.6 Millimoles per liter
Standard Deviation 2.30
|
2.0 Millimoles per liter
Standard Deviation 2.28
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Sodium; Day 5; n=9, 9
|
1.8 Millimoles per liter
Standard Deviation 2.77
|
1.4 Millimoles per liter
Standard Deviation 1.33
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Chloride; Day 2; n=18, 18
|
0.2 Millimoles per liter
Standard Deviation 2.05
|
0.7 Millimoles per liter
Standard Deviation 2.22
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Chloride; Day 5; n=9, 9
|
-0.2 Millimoles per liter
Standard Deviation 2.33
|
-0.7 Millimoles per liter
Standard Deviation 1.73
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Phosphate; Day 2; n=18, 18
|
0.077 Millimoles per liter
Standard Deviation 0.1177
|
0.077 Millimoles per liter
Standard Deviation 0.1223
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Phosphate; Day 5; n=9, 9
|
0.077 Millimoles per liter
Standard Deviation 0.1331
|
0.090 Millimoles per liter
Standard Deviation 0.1282
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
BUN; Day 2; n=18, 18
|
1.019 Millimoles per liter
Standard Deviation 0.9553
|
0.926 Millimoles per liter
Standard Deviation 1.0408
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
BUN; Day 5; n=9, 9
|
1.178 Millimoles per liter
Standard Deviation 1.0554
|
1.148 Millimoles per liter
Standard Deviation 0.6297
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Triglycerides; Day 2; n=18, 18
|
0.101 Millimoles per liter
Standard Deviation 0.4182
|
0.010 Millimoles per liter
Standard Deviation 0.4769
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Triglycerides; Day 5; n=9, 9
|
0.102 Millimoles per liter
Standard Deviation 0.2870
|
-0.221 Millimoles per liter
Standard Deviation 0.5382
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Cholesterol; Day 2; n=18, 18
|
-0.005 Millimoles per liter
Standard Deviation 0.3983
|
0.082 Millimoles per liter
Standard Deviation 0.4981
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Cholesterol; Day 5; n=9, 9
|
-0.148 Millimoles per liter
Standard Deviation 0.4463
|
-0.102 Millimoles per liter
Standard Deviation 0.6612
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Anion gap; Day 2; n=18, 18
|
0.6 Millimoles per liter
Standard Deviation 2.03
|
0.5 Millimoles per liter
Standard Deviation 1.95
|
—
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 1
Anion gap; Day 5; n=9, 9
|
0.8 Millimoles per liter
Standard Deviation 2.64
|
1.0 Millimoles per liter
Standard Deviation 1.22
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
ALT; Day 2; n=18, 18
|
-0.2 International units per liter
Standard Deviation 5.34
|
-3.6 International units per liter
Standard Deviation 8.39
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
ALT; Day 5; n=9, 9
|
1.3 International units per liter
Standard Deviation 7.87
|
-5.3 International units per liter
Standard Deviation 12.32
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
ALP; Day 2; n=18, 18
|
-2.4 International units per liter
Standard Deviation 5.25
|
-2.5 International units per liter
Standard Deviation 4.74
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
ALP; Day 5; n=9, 9
|
-1.7 International units per liter
Standard Deviation 7.40
|
-1.9 International units per liter
Standard Deviation 3.37
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
AST; Day 2; n=18, 18
|
-2.6 International units per liter
Standard Deviation 4.68
|
-4.2 International units per liter
Standard Deviation 6.57
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
AST; Day 5; n=9, 9
|
-1.4 International units per liter
Standard Deviation 3.84
|
-6.0 International units per liter
Standard Deviation 8.70
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
GGT; Day 2; n=18, 18
|
-1.2 International units per liter
Standard Deviation 1.93
|
-0.4 International units per liter
Standard Deviation 2.94
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
GGT; Day 5; n=9, 9
|
-2.1 International units per liter
Standard Deviation 2.47
|
-1.6 International units per liter
Standard Deviation 3.88
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
CK; Day 2; n=18, 18
|
-39.6 International units per liter
Standard Deviation 39.29
|
-34.8 International units per liter
Standard Deviation 53.99
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
CK; Day 5; n=9, 9
|
-23.3 International units per liter
Standard Deviation 28.33
|
-46.2 International units per liter
Standard Deviation 76.08
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
LDH; Day 2; n=18, 18
|
-18.7 International units per liter
Standard Deviation 11.00
|
-16.0 International units per liter
Standard Deviation 11.86
|
—
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 1
LDH; Day 5; n=9, 9
|
-13.9 International units per liter
Standard Deviation 16.12
|
-13.4 International units per liter
Standard Deviation 16.13
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Albumin; Day 2; n=18, 18
|
0.1 Grams per liter
Standard Deviation 2.80
|
0.7 Grams per liter
Standard Deviation 3.04
|
—
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Albumin; Day 5; n=9, 9
|
0.9 Grams per liter
Standard Deviation 3.37
|
1.0 Grams per liter
Standard Deviation 3.00
|
—
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Globulin; Day 2; n=18, 18
|
-0.6 Grams per liter
Standard Deviation 2.50
|
0.3 Grams per liter
Standard Deviation 2.37
|
—
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Globulin; Day 5; n=9, 9
|
-0.7 Grams per liter
Standard Deviation 2.78
|
-0.1 Grams per liter
Standard Deviation 1.76
|
—
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Protein; Day 2; n=18, 18
|
-0.5 Grams per liter
Standard Deviation 4.82
|
1.0 Grams per liter
Standard Deviation 4.79
|
—
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 1
Protein; Day 5; n=9, 9
|
0.2 Grams per liter
Standard Deviation 5.93
|
0.9 Grams per liter
Standard Deviation 4.54
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1
Amylase; Day 2; n=18, 18
|
3.3 Units per liter
Standard Deviation 5.66
|
4.3 Units per liter
Standard Deviation 8.75
|
—
|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1
Amylase; Day 5; n=9, 9
|
1.0 Units per liter
Standard Deviation 6.52
|
4.2 Units per liter
Standard Deviation 6.22
|
—
|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1
Lipase; Day 2; n=18, 18
|
2.7 Units per liter
Standard Deviation 8.27
|
2.2 Units per liter
Standard Deviation 5.15
|
—
|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 1
Lipase; Day 5; n=9, 9
|
4.0 Units per liter
Standard Deviation 6.56
|
1.6 Units per liter
Standard Deviation 3.28
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: creatinine, total bilirubin, direct bilirubin and urate. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Creatinine; Day 2; n=20, 19, 21
|
7.25 Micromoles per liter
Standard Deviation 5.306
|
7.41 Micromoles per liter
Standard Deviation 4.836
|
6.18 Micromoles per liter
Standard Deviation 4.833
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Creatinine; Day 5; n=7, 5, 7
|
10.10 Micromoles per liter
Standard Deviation 5.536
|
8.86 Micromoles per liter
Standard Deviation 4.565
|
7.19 Micromoles per liter
Standard Deviation 5.827
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Total bilirubin; Day 2; n=20, 19, 21
|
2.29 Micromoles per liter
Standard Deviation 2.650
|
2.47 Micromoles per liter
Standard Deviation 3.448
|
2.06 Micromoles per liter
Standard Deviation 2.729
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Total bilirubin; Day 5; n=7, 5, 7
|
3.89 Micromoles per liter
Standard Deviation 3.133
|
4.04 Micromoles per liter
Standard Deviation 4.689
|
1.69 Micromoles per liter
Standard Deviation 1.791
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Direct bilirubin; Day 2; n=20, 19, 21
|
0.21 Micromoles per liter
Standard Deviation 0.524
|
0.22 Micromoles per liter
Standard Deviation 0.550
|
0.18 Micromoles per liter
Standard Deviation 0.494
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Direct bilirubin; Day 5; n=7, 5, 7
|
0.31 Micromoles per liter
Standard Deviation 0.495
|
0.16 Micromoles per liter
Standard Deviation 0.611
|
0.11 Micromoles per liter
Standard Deviation 0.389
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Urate; Day 2; n=20, 19, 21
|
-16.5 Micromoles per liter
Standard Deviation 31.57
|
-0.5 Micromoles per liter
Standard Deviation 29.49
|
-13.8 Micromoles per liter
Standard Deviation 32.92
|
|
Change From Baseline in Chemistry Parameters: Creatinine, Total Bilirubin, Direct Bilirubin and Urate-Part 2
Urate; Day 5; n=7, 5, 7
|
-6.7 Micromoles per liter
Standard Deviation 29.86
|
-4.0 Micromoles per liter
Standard Deviation 34.62
|
3.3 Micromoles per liter
Standard Deviation 27.67
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: calcium, glucose, potassium, sodium, chloride, phosphate, BUN, triglycerides, cholesterol, anion gap and carbon dioxide. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Glucose; Day 2; n=20, 19, 21
|
-0.036 Millimoles per liter
Standard Deviation 0.2823
|
0.087 Millimoles per liter
Standard Deviation 0.2938
|
0.030 Millimoles per liter
Standard Deviation 0.2588
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Potassium; Day 5; n=7, 5, 7
|
-0.26 Millimoles per liter
Standard Deviation 0.270
|
-0.32 Millimoles per liter
Standard Deviation 0.377
|
-0.04 Millimoles per liter
Standard Deviation 0.282
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Sodium; Day 5; n=7, 5, 7
|
-1.9 Millimoles per liter
Standard Deviation 0.69
|
-2.0 Millimoles per liter
Standard Deviation 1.41
|
-1.4 Millimoles per liter
Standard Deviation 3.10
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
BUN; Day 2; n=20, 19, 21
|
0.307 Millimoles per liter
Standard Deviation 0.8732
|
0.257 Millimoles per liter
Standard Deviation 0.9884
|
0.213 Millimoles per liter
Standard Deviation 0.9258
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Calcium; Day 2; n=20, 19, 21
|
0.098 Millimoles per liter
Standard Deviation 0.0777
|
0.063 Millimoles per liter
Standard Deviation 0.0930
|
0.078 Millimoles per liter
Standard Deviation 0.0590
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Calcium; Day 5; n=7, 5, 7
|
0.097 Millimoles per liter
Standard Deviation 0.0663
|
0.068 Millimoles per liter
Standard Deviation 0.0867
|
0.067 Millimoles per liter
Standard Deviation 0.0702
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Glucose; Day 5; n=7, 5, 7
|
-0.207 Millimoles per liter
Standard Deviation 0.3073
|
-0.100 Millimoles per liter
Standard Deviation 0.2547
|
0.113 Millimoles per liter
Standard Deviation 0.3935
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Potassium; Day 2; n=20, 19, 21
|
0.08 Millimoles per liter
Standard Deviation 0.249
|
-0.01 Millimoles per liter
Standard Deviation 0.273
|
-0.02 Millimoles per liter
Standard Deviation 0.270
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Sodium; Day 2; n=20, 19, 21
|
-0.5 Millimoles per liter
Standard Deviation 2.06
|
-0.5 Millimoles per liter
Standard Deviation 2.59
|
-1.0 Millimoles per liter
Standard Deviation 2.00
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Chloride; Day 2; n=20, 19, 21
|
-0.5 Millimoles per liter
Standard Deviation 1.67
|
-0.2 Millimoles per liter
Standard Deviation 1.78
|
-0.3 Millimoles per liter
Standard Deviation 2.29
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Chloride; Day 5; n=7, 5, 7
|
-1.9 Millimoles per liter
Standard Deviation 0.90
|
-2.2 Millimoles per liter
Standard Deviation 1.10
|
-1.0 Millimoles per liter
Standard Deviation 2.89
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Phosphate; Day 2; n=20, 19, 21
|
0.087 Millimoles per liter
Standard Deviation 0.0836
|
0.065 Millimoles per liter
Standard Deviation 0.0973
|
0.076 Millimoles per liter
Standard Deviation 0.0815
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Phosphate; Day 5; n=7, 5, 7
|
0.060 Millimoles per liter
Standard Deviation 0.0856
|
0.124 Millimoles per liter
Standard Deviation 0.0953
|
0.074 Millimoles per liter
Standard Deviation 0.0820
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
BUN; Day 5; n=7, 5, 7
|
0.783 Millimoles per liter
Standard Deviation 1.1942
|
0.684 Millimoles per liter
Standard Deviation 0.7695
|
0.506 Millimoles per liter
Standard Deviation 0.9007
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Triglycerides; Day 2; n=20, 19, 21
|
0.115 Millimoles per liter
Standard Deviation 0.2130
|
0.127 Millimoles per liter
Standard Deviation 0.2750
|
0.062 Millimoles per liter
Standard Deviation 0.2884
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Triglycerides; Day 5; n=7, 5, 7
|
0.021 Millimoles per liter
Standard Deviation 0.2874
|
0.226 Millimoles per liter
Standard Deviation 0.1254
|
0.273 Millimoles per liter
Standard Deviation 0.5007
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Cholesterol; Day 2; n=20, 19, 21
|
0.103 Millimoles per liter
Standard Deviation 0.4625
|
0.078 Millimoles per liter
Standard Deviation 0.5175
|
0.077 Millimoles per liter
Standard Deviation 0.4478
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Cholesterol; Day 5; n=7, 5, 7
|
-0.033 Millimoles per liter
Standard Deviation 0.5333
|
-0.286 Millimoles per liter
Standard Deviation 0.3791
|
-0.339 Millimoles per liter
Standard Deviation 0.3855
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Anion gap; Day 2; n=20, 19, 21
|
-0.8 Millimoles per liter
Standard Deviation 1.41
|
-0.9 Millimoles per liter
Standard Deviation 2.13
|
-0.5 Millimoles per liter
Standard Deviation 1.66
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Anion gap; Day 5; n=7, 5, 7
|
1.0 Millimoles per liter
Standard Deviation 1.73
|
0.4 Millimoles per liter
Standard Deviation 1.67
|
-0.7 Millimoles per liter
Standard Deviation 1.98
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Carbon dioxide; Day 2; n=20, 19, 21
|
0.9 Millimoles per liter
Standard Deviation 1.59
|
0.8 Millimoles per liter
Standard Deviation 1.18
|
-0.1 Millimoles per liter
Standard Deviation 2.10
|
|
Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Chloride, Phosphate, BUN, Triglycerides, Cholesterol, Anion Gap, Carbon Dioxide-Part 2
Carbon dioxide; Day 5; n=7, 5, 7
|
-1.0 Millimoles per liter
Standard Deviation 2.00
|
-0.4 Millimoles per liter
Standard Deviation 2.30
|
0.4 Millimoles per liter
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: ALT, ALP, AST, GGT, CK and LDH. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
LDH; Day 5; n=7, 5, 7
|
-17.3 International units per liter
Standard Deviation 14.95
|
-17.8 International units per liter
Standard Deviation 3.27
|
-10.4 International units per liter
Standard Deviation 15.05
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALT; Day 2; n=20, 19, 21
|
-4.9 International units per liter
Standard Deviation 8.61
|
-2.5 International units per liter
Standard Deviation 4.06
|
-2.2 International units per liter
Standard Deviation 8.48
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALT; Day 5; n=7, 5, 7
|
-9.7 International units per liter
Standard Deviation 13.03
|
-3.4 International units per liter
Standard Deviation 4.39
|
5.7 International units per liter
Standard Deviation 9.23
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALP; Day 2; n=20, 19, 21
|
6.1 International units per liter
Standard Deviation 5.61
|
5.9 International units per liter
Standard Deviation 5.91
|
6.3 International units per liter
Standard Deviation 6.21
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
ALP; Day 5; n=7, 5, 7
|
3.9 International units per liter
Standard Deviation 6.69
|
2.2 International units per liter
Standard Deviation 6.22
|
-0.4 International units per liter
Standard Deviation 6.50
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
AST; Day 2; n=20, 19, 21
|
-3.3 International units per liter
Standard Deviation 5.18
|
-2.6 International units per liter
Standard Deviation 4.40
|
-2.0 International units per liter
Standard Deviation 4.88
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
AST; Day 5; n=7, 5, 7
|
-5.1 International units per liter
Standard Deviation 6.26
|
-2.8 International units per liter
Standard Deviation 4.66
|
0.6 International units per liter
Standard Deviation 3.36
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
GGT; Day 2; n=20, 19, 21
|
-1.1 International units per liter
Standard Deviation 2.65
|
-0.4 International units per liter
Standard Deviation 1.80
|
0.2 International units per liter
Standard Deviation 3.09
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
GGT; Day 5; n=7, 5, 7
|
-2.4 International units per liter
Standard Deviation 3.31
|
-1.4 International units per liter
Standard Deviation 2.70
|
2.1 International units per liter
Standard Deviation 5.73
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
CK; Day 2; n=20, 19, 21
|
-15.4 International units per liter
Standard Deviation 27.15
|
-10.7 International units per liter
Standard Deviation 40.57
|
-12.6 International units per liter
Standard Deviation 31.50
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
CK; Day 5; n=7, 5, 7
|
1.1 International units per liter
Standard Deviation 78.79
|
9.4 International units per liter
Standard Deviation 92.62
|
29.9 International units per liter
Standard Deviation 152.85
|
|
Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, CK, LDH-Part 2
LDH; Day 2; n=20, 19, 21
|
-12.2 International units per liter
Standard Deviation 10.28
|
-12.4 International units per liter
Standard Deviation 12.05
|
-11.5 International units per liter
Standard Deviation 11.97
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: albumin, globulin and protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Albumin; Day 5; n=7, 5, 7
|
3.4 Grams per liter
Standard Deviation 1.40
|
1.8 Grams per liter
Standard Deviation 0.84
|
1.1 Grams per liter
Standard Deviation 1.46
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Albumin; Day 2; n=20, 19, 21
|
2.0 Grams per liter
Standard Deviation 1.85
|
1.8 Grams per liter
Standard Deviation 2.57
|
1.9 Grams per liter
Standard Deviation 1.95
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Globulin; Day 2; n=20, 19, 21
|
0.2 Grams per liter
Standard Deviation 1.79
|
-0.1 Grams per liter
Standard Deviation 2.26
|
-0.1 Grams per liter
Standard Deviation 1.76
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Globulin; Day 5; n=7, 5, 7
|
0.1 Grams per liter
Standard Deviation 1.86
|
0.1 Grams per liter
Standard Deviation 3.39
|
-1.3 Grams per liter
Standard Deviation 1.80
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Protein; Day 2; n=20, 19, 21
|
2.1 Grams per liter
Standard Deviation 3.01
|
1.7 Grams per liter
Standard Deviation 4.28
|
1.8 Grams per liter
Standard Deviation 3.01
|
|
Change From Baseline in Chemistry Parameters: Albumin, Globulin and Protein-Part 2
Protein; Day 5; n=7, 5, 7
|
3.6 Grams per liter
Standard Deviation 2.23
|
2.8 Grams per liter
Standard Deviation 4.09
|
-0.1 Grams per liter
Standard Deviation 3.02
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected for the assessment of following clinical chemistry parameters: amylase and lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2
Amylase; Day 2; n=20, 19, 21
|
0.7 Units per liter
Standard Deviation 5.68
|
1.8 Units per liter
Standard Deviation 8.70
|
0.8 Units per liter
Standard Deviation 8.27
|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2
Amylase; Day 5; n=7, 5, 7
|
4.4 Units per liter
Standard Deviation 4.86
|
-1.8 Units per liter
Standard Deviation 10.16
|
-4.4 Units per liter
Standard Deviation 8.26
|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2
Lipase; Day 2; n=20, 19, 21
|
-2.6 Units per liter
Standard Deviation 15.99
|
-1.4 Units per liter
Standard Deviation 13.01
|
0.3 Units per liter
Standard Deviation 17.39
|
|
Change From Baseline in Chemistry Parameters: Amylase and Lipase-Part 2
Lipase; Day 5; n=7, 5, 7
|
6.3 Units per liter
Standard Deviation 7.54
|
-3.0 Units per liter
Standard Deviation 14.27
|
-9.6 Units per liter
Standard Deviation 24.84
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Urine Parameter: Specific Gravity-Part 1
Day 2; n=18, 18
|
1.0152 Ratio
Standard Deviation 0.00685
|
1.0158 Ratio
Standard Deviation 0.00584
|
—
|
|
Absolute Values for Urine Parameter: Specific Gravity-Part 1
Baseline; n=18, 18
|
1.0120 Ratio
Standard Deviation 0.00915
|
1.0120 Ratio
Standard Deviation 0.00915
|
—
|
|
Absolute Values for Urine Parameter: Specific Gravity-Part 1
Day 5; n=9, 9
|
1.0201 Ratio
Standard Deviation 0.00664
|
1.0161 Ratio
Standard Deviation 0.00434
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine urobilinogen.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Urine Parameter: Urobilinogen-Part 1
Baseline; n=18, 18
|
4.1384 Micromoles per liter
Standard Deviation 3.19235
|
4.1384 Micromoles per liter
Standard Deviation 3.19235
|
—
|
|
Absolute Values for Urine Parameter: Urobilinogen-Part 1
Day 2; n=18, 18
|
3.3860 Micromoles per liter
Standard Deviation 0.00000
|
4.1384 Micromoles per liter
Standard Deviation 3.19235
|
—
|
|
Absolute Values for Urine Parameter: Urobilinogen-Part 1
Day 5; n=9, 9
|
3.3860 Micromoles per liter
Standard Deviation 0.00000
|
3.3860 Micromoles per liter
Standard Deviation 0.00000
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1
Day 2; n=18, 18
|
6.14 pH
Standard Deviation 0.682
|
6.25 pH
Standard Deviation 0.600
|
—
|
|
Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1
Baseline; n=18, 18
|
6.03 pH
Standard Deviation 0.696
|
6.03 pH
Standard Deviation 0.696
|
—
|
|
Absolute Values for Urine Parameter: Potential of Hydrogen (pH)-Part 1
Day 5; n=9, 9
|
5.72 pH
Standard Deviation 0.441
|
5.89 pH
Standard Deviation 0.697
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Urine Parameter: Specific Gravity-Part 2
Baseline; n=20, 19, 21
|
1.0080 Ratio
Standard Deviation 0.00735
|
1.0080 Ratio
Standard Deviation 0.00735
|
1.0080 Ratio
Standard Deviation 0.00735
|
|
Absolute Values for Urine Parameter: Specific Gravity-Part 2
Day 5; n=7, 5, 7
|
1.0180 Ratio
Standard Deviation 0.00632
|
1.0248 Ratio
Standard Deviation 0.00526
|
1.0171 Ratio
Standard Deviation 0.00999
|
|
Absolute Values for Urine Parameter: Specific Gravity-Part 2
Day 2; n=20, 19, 21
|
1.0166 Ratio
Standard Deviation 0.00675
|
1.0151 Ratio
Standard Deviation 0.00552
|
1.0163 Ratio
Standard Deviation 0.00419
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine urobilinogen.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Urine Parameter: Urobilinogen-Part 2
Day 5; n=7, 5, 7
|
3.3860 Micromoles per liter
Standard Deviation 0.00000
|
6.0948 Micromoles per liter
Standard Deviation 6.05706
|
5.3209 Micromoles per liter
Standard Deviation 5.11915
|
|
Absolute Values for Urine Parameter: Urobilinogen-Part 2
Baseline; n=20, 19, 21
|
4.6759 Micromoles per liter
Standard Deviation 4.03794
|
4.6759 Micromoles per liter
Standard Deviation 4.03794
|
4.6759 Micromoles per liter
Standard Deviation 4.03794
|
|
Absolute Values for Urine Parameter: Urobilinogen-Part 2
Day 2; n=20, 19, 21
|
4.0632 Micromoles per liter
Standard Deviation 3.02853
|
3.3860 Micromoles per liter
Standard Deviation 0.00000
|
3.3860 Micromoles per liter
Standard Deviation 0.00000
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0).
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Urine Parameter: pH-Part 2
Baseline; n=20, 19, 21
|
6.36 pH
Standard Deviation 0.727
|
6.36 pH
Standard Deviation 0.727
|
6.36 pH
Standard Deviation 0.727
|
|
Absolute Values for Urine Parameter: pH-Part 2
Day 2; n=20, 19, 21
|
6.15 pH
Standard Deviation 0.690
|
6.08 pH
Standard Deviation 0.584
|
6.10 pH
Standard Deviation 0.718
|
|
Absolute Values for Urine Parameter: pH-Part 2
Day 5; n=7, 5, 7
|
5.86 pH
Standard Deviation 0.627
|
5.60 pH
Standard Deviation 0.418
|
6.21 pH
Standard Deviation 0.393
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Urine Parameter: Specific Gravity-Part 1
Day 5; n=9, 9
|
0.0088 Ratio
Standard Deviation 0.01210
|
0.0034 Ratio
Standard Deviation 0.01180
|
—
|
|
Change From Baseline in Urine Parameter: Specific Gravity-Part 1
Day 2; n=18, 18
|
0.0032 Ratio
Standard Deviation 0.01242
|
0.0038 Ratio
Standard Deviation 0.01043
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Urine Parameter: Urobilinogen-Part 1
Day 2; n=18, 18
|
-0.7524 Micromoles per liter
Standard Deviation 3.19235
|
0.0000 Micromoles per liter
Standard Deviation 4.64555
|
—
|
|
Change From Baseline in Urine Parameter: Urobilinogen-Part 1
Day 5; n=9, 9
|
0.0000 Micromoles per liter
Standard Deviation 0.00000
|
-1.5049 Micromoles per liter
Standard Deviation 4.51467
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Urine Parameter: pH-Part 1
Day 2; n=18, 18
|
0.11 pH
Standard Deviation 1.008
|
0.22 pH
Standard Deviation 0.974
|
—
|
|
Change From Baseline in Urine Parameter: pH-Part 1
Day 5; n=9, 9
|
-0.17 pH
Standard Deviation 0.559
|
-0.28 pH
Standard Deviation 1.121
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Urine Parameter: Specific Gravity-Part 2
Day 2; n=20, 19, 21
|
0.0084 Ratio
Standard Deviation 0.00942
|
0.0066 Ratio
Standard Deviation 0.00718
|
0.0083 Ratio
Standard Deviation 0.00728
|
|
Change From Baseline in Urine Parameter: Specific Gravity-Part 2
Day 5; n=7, 5, 7
|
0.0109 Ratio
Standard Deviation 0.00825
|
0.0140 Ratio
Standard Deviation 0.01142
|
0.0091 Ratio
Standard Deviation 0.00956
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Urine Parameter: Urobilinogen-Part 2
Day 2; n=20, 19, 21
|
-0.6772 Micromoles per liter
Standard Deviation 5.33680
|
-1.4275 Micromoles per liter
Standard Deviation 4.27045
|
-1.2899 Micromoles per liter
Standard Deviation 4.07394
|
|
Change From Baseline in Urine Parameter: Urobilinogen-Part 2
Day 5; n=7, 5, 7
|
0.0000 Micromoles per liter
Standard Deviation 0.00000
|
-2.7088 Micromoles per liter
Standard Deviation 6.05706
|
1.9349 Micromoles per liter
Standard Deviation 5.11915
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 2 and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were collected at indicated time points for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Urine Parameter: pH-Part 2
Day 5; n=7, 5, 7
|
-0.43 pH
Standard Deviation 0.787
|
-0.80 pH
Standard Deviation 0.837
|
0.07 pH
Standard Deviation 0.450
|
|
Change From Baseline in Urine Parameter: pH-Part 2
Day 2; n=20, 19, 21
|
-0.18 pH
Standard Deviation 0.799
|
-0.18 pH
Standard Deviation 0.730
|
-0.26 pH
Standard Deviation 0.664
|
SECONDARY outcome
Timeframe: Day 2 and Day 5Population: Safety Population
Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 1
Leukocyte esterase, Day 2, Trace
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 1
Leukocyte esterase, Day 2, 1+
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 1
Leukocyte esterase, Day 5, Trace
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 1
Leukocyte esterase, Day 5, 1+
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 1
Occult blood, Day 2, Trace
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 1
Occult blood, Day 2, 1+
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 2 and Day 5Population: Safety Population
Urine samples were collected at indicated time points for the assessment of following urine parameters: bilirubin, glucose, ketones, nitrite, leukocyte esterase, occult blood and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Only parameters and time points with abnormal results have been presented.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 2
Ketones; Day 5; Trace
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 2
Ketones; Day 5; 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 2
Leukocyte esterase; Day 2; 1+
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 2
Occult blood; Day 2; Trace
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 2
Occult blood; Day 2; 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urine Dipstick Results-Part 2
Occult blood; Day 2; 3+
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QT interval, Day 1 (2 hours); n=18, 18
|
383.3 Milliseconds
Standard Deviation 13.71
|
383.6 Milliseconds
Standard Deviation 24.11
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
PR interval, Baseline; n=18, 18
|
164.1 Milliseconds
Standard Deviation 22.81
|
162.3 Milliseconds
Standard Deviation 20.76
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
PR interval, Day 1 (2 hours); n=18, 18
|
166.3 Milliseconds
Standard Deviation 21.55
|
158.7 Milliseconds
Standard Deviation 19.95
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
PR interval, Day 1 (4 hours); n=18, 18
|
160.6 Milliseconds
Standard Deviation 20.94
|
158.9 Milliseconds
Standard Deviation 19.19
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
PR interval, Day 5; n=9, 9
|
161.8 Milliseconds
Standard Deviation 11.68
|
169.3 Milliseconds
Standard Deviation 26.14
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QRS duration, Baseline; n=18, 18
|
93.4 Milliseconds
Standard Deviation 9.30
|
92.5 Milliseconds
Standard Deviation 8.09
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QRS duration, Day 1 (2 hours); n=18, 18
|
91.9 Milliseconds
Standard Deviation 8.76
|
92.6 Milliseconds
Standard Deviation 9.00
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QRS duration, Day 1 (4 hours); n=18, 18
|
94.1 Milliseconds
Standard Deviation 8.88
|
93.8 Milliseconds
Standard Deviation 9.90
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QRS duration, Day 5; n=9, 9
|
94.3 Milliseconds
Standard Deviation 11.65
|
92.4 Milliseconds
Standard Deviation 8.25
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QT interval, Baseline; n=18, 18
|
395.1 Milliseconds
Standard Deviation 14.22
|
394.4 Milliseconds
Standard Deviation 24.04
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QT interval, Day 1 (4 hours); n=18, 18
|
404.8 Milliseconds
Standard Deviation 16.36
|
402.0 Milliseconds
Standard Deviation 27.67
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QT interval, Day 5; n=9, 9
|
393.4 Milliseconds
Standard Deviation 16.38
|
402.7 Milliseconds
Standard Deviation 18.71
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QTcF interval, Baseline; n=18, 18
|
399.4 Milliseconds
Standard Deviation 9.76
|
401.9 Milliseconds
Standard Deviation 15.01
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QTcF interval, Day 1 (2 hours); n=18, 18
|
389.5 Milliseconds
Standard Deviation 12.11
|
392.8 Milliseconds
Standard Deviation 15.09
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QTcF interval, Day 1 (4 hours); n=18, 18
|
398.7 Milliseconds
Standard Deviation 11.13
|
402.6 Milliseconds
Standard Deviation 19.46
|
—
|
|
Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF)-Part 1
QTcF interval, Day 5; n=9, 9
|
400.8 Milliseconds
Standard Deviation 13.34
|
399.4 Milliseconds
Standard Deviation 11.98
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
PR interval, Baseline; n=20, 19, 21
|
166.4 Milliseconds
Standard Deviation 16.48
|
166.2 Milliseconds
Standard Deviation 15.40
|
166.8 Milliseconds
Standard Deviation 17.01
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
PR interval, Day 1 (2 hours); n=20, 19, 21
|
163.9 Milliseconds
Standard Deviation 18.45
|
166.8 Milliseconds
Standard Deviation 15.23
|
161.7 Milliseconds
Standard Deviation 16.82
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
PR interval, Day 1 (4 hours); n=20, 19, 21
|
165.2 Milliseconds
Standard Deviation 17.74
|
165.7 Milliseconds
Standard Deviation 15.29
|
162.6 Milliseconds
Standard Deviation 13.99
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
PR interval, Day 5; n=7, 5, 7
|
173.4 Milliseconds
Standard Deviation 19.16
|
171.6 Milliseconds
Standard Deviation 14.57
|
163.1 Milliseconds
Standard Deviation 12.36
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QRS duration, Baseline; n=20, 19, 21
|
92.1 Milliseconds
Standard Deviation 9.76
|
91.7 Milliseconds
Standard Deviation 9.02
|
90.1 Milliseconds
Standard Deviation 10.42
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QRS duration, Day 1 (2 hours); n=20, 19, 21
|
88.9 Milliseconds
Standard Deviation 9.68
|
92.6 Milliseconds
Standard Deviation 9.82
|
89.7 Milliseconds
Standard Deviation 9.86
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QRS duration, Day 1 (4 hours); n=20, 19, 21
|
91.1 Milliseconds
Standard Deviation 10.63
|
93.2 Milliseconds
Standard Deviation 8.45
|
90.3 Milliseconds
Standard Deviation 8.69
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QRS duration, Day 5; n=7, 5, 7
|
101.1 Milliseconds
Standard Deviation 7.10
|
85.8 Milliseconds
Standard Deviation 8.07
|
88.7 Milliseconds
Standard Deviation 5.28
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QT interval, Baseline; n=20, 19, 21
|
391.8 Milliseconds
Standard Deviation 28.22
|
388.5 Milliseconds
Standard Deviation 24.78
|
389.7 Milliseconds
Standard Deviation 26.09
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QT interval, Day 1 (2 hours); n=20, 19, 21
|
379.7 Milliseconds
Standard Deviation 25.70
|
399.2 Milliseconds
Standard Deviation 22.43
|
376.2 Milliseconds
Standard Deviation 22.54
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QT interval, Day 1 (4 hours); n=20, 19, 21
|
401.0 Milliseconds
Standard Deviation 25.84
|
406.9 Milliseconds
Standard Deviation 22.25
|
389.1 Milliseconds
Standard Deviation 25.95
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QT interval, Day 5; n=7, 5, 7
|
401.7 Milliseconds
Standard Deviation 33.29
|
391.0 Milliseconds
Standard Deviation 10.27
|
378.9 Milliseconds
Standard Deviation 25.15
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QTcF interval, Baseline; n=20, 19, 21
|
395.3 Milliseconds
Standard Deviation 21.06
|
392.4 Milliseconds
Standard Deviation 19.45
|
391.9 Milliseconds
Standard Deviation 21.63
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QTcF interval, Day 1 (2 hours); n=20, 19, 21
|
384.0 Milliseconds
Standard Deviation 19.91
|
391.7 Milliseconds
Standard Deviation 21.77
|
388.3 Milliseconds
Standard Deviation 18.91
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QTcF interval, Day 1 (4 hours); n=20, 19, 21
|
396.8 Milliseconds
Standard Deviation 21.90
|
395.5 Milliseconds
Standard Deviation 20.75
|
393.3 Milliseconds
Standard Deviation 20.78
|
|
Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QTcF interval, Day 5; n=7, 5, 7
|
391.9 Milliseconds
Standard Deviation 30.45
|
402.4 Milliseconds
Standard Deviation 7.70
|
388.1 Milliseconds
Standard Deviation 22.81
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QRS duration, Day 5; n=9, 9
|
-0.3 Milliseconds
Standard Deviation 3.74
|
0.8 Milliseconds
Standard Deviation 3.46
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QT interval, Day 1 (2 hours); n=18, 18
|
-11.8 Milliseconds
Standard Deviation 10.70
|
-10.8 Milliseconds
Standard Deviation 11.18
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QT interval, Day 1 (4 hours); n=18, 18
|
9.7 Milliseconds
Standard Deviation 13.99
|
7.6 Milliseconds
Standard Deviation 16.85
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QT interval, Day 5; n=9, 9
|
-1.3 Milliseconds
Standard Deviation 10.00
|
5.0 Milliseconds
Standard Deviation 26.51
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QTcF interval, Day 1 (2 hours); n=18, 18
|
-9.9 Milliseconds
Standard Deviation 6.49
|
-9.1 Milliseconds
Standard Deviation 9.16
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QTcF interval, Day 1 (4 hours); n=18, 18
|
-0.7 Milliseconds
Standard Deviation 7.71
|
0.7 Milliseconds
Standard Deviation 9.23
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QTcF interval, Day 5; n=9, 9
|
-0.7 Milliseconds
Standard Deviation 7.19
|
3.9 Milliseconds
Standard Deviation 7.93
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
PR interval, Day 1 (2 hours); n=18, 18
|
2.2 Milliseconds
Standard Deviation 8.35
|
-3.6 Milliseconds
Standard Deviation 10.01
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
PR interval, Day 1 (4 hours); n=18, 18
|
-3.6 Milliseconds
Standard Deviation 11.61
|
-3.3 Milliseconds
Standard Deviation 10.85
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
PR interval, Day 5; n=9, 9
|
-0.9 Milliseconds
Standard Deviation 13.72
|
3.2 Milliseconds
Standard Deviation 8.35
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QRS duration, Day 1 (2 hours); n=18, 18
|
-1.5 Milliseconds
Standard Deviation 2.81
|
0.1 Milliseconds
Standard Deviation 6.06
|
—
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 1
QRS duration, Day 1 (4 hours); n=18, 18
|
0.7 Milliseconds
Standard Deviation 3.63
|
1.3 Milliseconds
Standard Deviation 4.92
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Day 1 (2 hours and 4 hours) and Day 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QRS duration, Day 1 (4 hours); n=20, 19, 21
|
-1.0 Milliseconds
Standard Deviation 4.18
|
1.5 Milliseconds
Standard Deviation 4.45
|
0.2 Milliseconds
Standard Deviation 4.12
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QT interval, Day 1 (2 hours); n=20, 19, 21
|
-12.1 Milliseconds
Standard Deviation 18.05
|
10.6 Milliseconds
Standard Deviation 12.36
|
-13.4 Milliseconds
Standard Deviation 15.31
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QTcF interval, Day 1 (2 hours); n=20, 19, 21
|
-11.3 Milliseconds
Standard Deviation 7.04
|
-0.6 Milliseconds
Standard Deviation 7.33
|
-3.5 Milliseconds
Standard Deviation 8.70
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QTcF interval, Day 5; n=7, 5, 7
|
-0.4 Milliseconds
Standard Deviation 9.34
|
-1.4 Milliseconds
Standard Deviation 3.91
|
1.7 Milliseconds
Standard Deviation 8.30
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
PR interval, Day 1 (2 hours); n=20, 19, 21
|
-2.5 Milliseconds
Standard Deviation 7.02
|
0.7 Milliseconds
Standard Deviation 7.90
|
-5.0 Milliseconds
Standard Deviation 8.29
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
PR interval, Day 1 (4 hours); n=20, 19, 21
|
-1.2 Milliseconds
Standard Deviation 8.47
|
-0.4 Milliseconds
Standard Deviation 11.52
|
-4.2 Milliseconds
Standard Deviation 6.79
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
PR interval, Day 5; n=7, 5, 7
|
2.0 Milliseconds
Standard Deviation 4.08
|
1.6 Milliseconds
Standard Deviation 11.26
|
-2.7 Milliseconds
Standard Deviation 16.42
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QRS duration, Day 1 (2 hours); n=20, 19, 21
|
-3.2 Milliseconds
Standard Deviation 3.44
|
0.9 Milliseconds
Standard Deviation 3.90
|
-0.5 Milliseconds
Standard Deviation 3.03
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QRS duration, Day 5; n=7, 5, 7
|
0.4 Milliseconds
Standard Deviation 3.21
|
-0.4 Milliseconds
Standard Deviation 3.13
|
0.4 Milliseconds
Standard Deviation 2.88
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QT interval, Day 1 (4 hours); n=20, 19, 21
|
9.2 Milliseconds
Standard Deviation 18.08
|
18.4 Milliseconds
Standard Deviation 12.90
|
-0.6 Milliseconds
Standard Deviation 14.14
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QT interval, Day 5; n=7, 5, 7
|
-2.1 Milliseconds
Standard Deviation 10.67
|
-12.4 Milliseconds
Standard Deviation 13.28
|
-2.9 Milliseconds
Standard Deviation 7.95
|
|
Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTcF Interval-Part 2
QTcF interval, Day 1 (4 hours); n=20, 19, 21
|
1.6 Milliseconds
Standard Deviation 7.50
|
3.1 Milliseconds
Standard Deviation 7.75
|
1.4 Milliseconds
Standard Deviation 7.64
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
SBP; Day 2
|
113.8 Millimeters of mercury
Standard Deviation 10.32
|
115.1 Millimeters of mercury
Standard Deviation 11.94
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
SBP; Day 3
|
113.6 Millimeters of mercury
Standard Deviation 12.13
|
113.3 Millimeters of mercury
Standard Deviation 9.71
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
SBP; Day 4
|
112.2 Millimeters of mercury
Standard Deviation 11.11
|
113.9 Millimeters of mercury
Standard Deviation 10.57
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
DBP; Day 2
|
70.1 Millimeters of mercury
Standard Deviation 7.06
|
71.3 Millimeters of mercury
Standard Deviation 10.56
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
SBP; Baseline
|
118.3 Millimeters of mercury
Standard Deviation 9.73
|
117.4 Millimeters of mercury
Standard Deviation 12.26
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
SBP; Day 5
|
112.2 Millimeters of mercury
Standard Deviation 9.62
|
113.8 Millimeters of mercury
Standard Deviation 8.91
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
DBP; Baseline
|
72.1 Millimeters of mercury
Standard Deviation 8.35
|
73.4 Millimeters of mercury
Standard Deviation 8.51
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
DBP; Day 3
|
70.4 Millimeters of mercury
Standard Deviation 7.72
|
69.1 Millimeters of mercury
Standard Deviation 8.46
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
DBP; Day 4
|
70.2 Millimeters of mercury
Standard Deviation 6.98
|
68.7 Millimeters of mercury
Standard Deviation 6.77
|
—
|
|
Absolute Values for Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)-Part 1
DBP; Day 5
|
70.1 Millimeters of mercury
Standard Deviation 7.68
|
68.9 Millimeters of mercury
Standard Deviation 5.76
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Sign: Pulse Rate-Part 1
Day 5
|
64.4 Beats per minute
Standard Deviation 6.97
|
66.9 Beats per minute
Standard Deviation 8.39
|
—
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 1
Baseline
|
65.7 Beats per minute
Standard Deviation 5.27
|
66.2 Beats per minute
Standard Deviation 10.00
|
—
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 1
Day 2
|
66.7 Beats per minute
Standard Deviation 7.02
|
68.4 Beats per minute
Standard Deviation 8.71
|
—
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 1
Day 3
|
67.4 Beats per minute
Standard Deviation 7.79
|
68.6 Beats per minute
Standard Deviation 9.58
|
—
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 1
Day 4
|
67.4 Beats per minute
Standard Deviation 7.89
|
65.6 Beats per minute
Standard Deviation 9.37
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 1
Baseline; n=18, 18
|
14.0 Breaths per minute
Standard Deviation 2.66
|
14.9 Breaths per minute
Standard Deviation 1.71
|
—
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 1
Day 2; n=17, 17
|
13.1 Breaths per minute
Standard Deviation 2.56
|
13.9 Breaths per minute
Standard Deviation 2.69
|
—
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 1
Day 3; n=17, 18
|
14.7 Breaths per minute
Standard Deviation 2.11
|
15.2 Breaths per minute
Standard Deviation 2.49
|
—
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 1
Day 4; n=18, 18
|
13.9 Breaths per minute
Standard Deviation 2.87
|
14.7 Breaths per minute
Standard Deviation 3.07
|
—
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 1
Day 5; n=18, 18
|
14.0 Breaths per minute
Standard Deviation 2.47
|
14.1 Breaths per minute
Standard Deviation 1.75
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Sign: Temperature-Part 1
Day 2
|
36.22 Degrees Celsius
Standard Deviation 0.426
|
36.39 Degrees Celsius
Standard Deviation 0.407
|
—
|
|
Absolute Values for Vital Sign: Temperature-Part 1
Day 4
|
36.38 Degrees Celsius
Standard Deviation 0.402
|
36.35 Degrees Celsius
Standard Deviation 0.385
|
—
|
|
Absolute Values for Vital Sign: Temperature-Part 1
Day 5
|
36.21 Degrees Celsius
Standard Deviation 0.555
|
36.27 Degrees Celsius
Standard Deviation 0.324
|
—
|
|
Absolute Values for Vital Sign: Temperature-Part 1
Baseline
|
36.24 Degrees Celsius
Standard Deviation 0.393
|
36.37 Degrees Celsius
Standard Deviation 0.361
|
—
|
|
Absolute Values for Vital Sign: Temperature-Part 1
Day 3
|
36.33 Degrees Celsius
Standard Deviation 0.420
|
36.22 Degrees Celsius
Standard Deviation 0.383
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
DBP, Baseline
|
74.8 Millimeters of mercury
Standard Deviation 10.44
|
71.4 Millimeters of mercury
Standard Deviation 9.62
|
71.8 Millimeters of mercury
Standard Deviation 7.51
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
SBP, Baseline
|
120.8 Millimeters of mercury
Standard Deviation 17.53
|
115.2 Millimeters of mercury
Standard Deviation 11.46
|
117.4 Millimeters of mercury
Standard Deviation 13.01
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
SBP, Day 2
|
117.4 Millimeters of mercury
Standard Deviation 11.84
|
116.6 Millimeters of mercury
Standard Deviation 11.32
|
115.7 Millimeters of mercury
Standard Deviation 11.73
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
SBP, Day 3
|
115.8 Millimeters of mercury
Standard Deviation 10.63
|
117.2 Millimeters of mercury
Standard Deviation 11.47
|
116.6 Millimeters of mercury
Standard Deviation 12.36
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
SBP, Day 4
|
119.0 Millimeters of mercury
Standard Deviation 12.75
|
115.4 Millimeters of mercury
Standard Deviation 11.14
|
118.0 Millimeters of mercury
Standard Deviation 16.87
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
SBP, Day 5
|
118.2 Millimeters of mercury
Standard Deviation 12.92
|
115.8 Millimeters of mercury
Standard Deviation 12.76
|
118.0 Millimeters of mercury
Standard Deviation 13.18
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
DBP, Day 2
|
72.5 Millimeters of mercury
Standard Deviation 9.26
|
74.2 Millimeters of mercury
Standard Deviation 9.83
|
71.1 Millimeters of mercury
Standard Deviation 7.48
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
DBP, Day 3
|
72.9 Millimeters of mercury
Standard Deviation 7.57
|
72.9 Millimeters of mercury
Standard Deviation 9.24
|
72.4 Millimeters of mercury
Standard Deviation 7.53
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
DBP, Day 4
|
71.9 Millimeters of mercury
Standard Deviation 6.94
|
73.5 Millimeters of mercury
Standard Deviation 8.32
|
70.5 Millimeters of mercury
Standard Deviation 9.26
|
|
Absolute Values for Vital Signs: DBP and SBP-Part 2
DBP, Day 5
|
72.0 Millimeters of mercury
Standard Deviation 8.61
|
72.3 Millimeters of mercury
Standard Deviation 7.64
|
68.7 Millimeters of mercury
Standard Deviation 9.18
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Sign: Pulse Rate-Part 2
Day 2
|
66.9 Beats per minute
Standard Deviation 12.76
|
64.0 Beats per minute
Standard Deviation 10.66
|
64.1 Beats per minute
Standard Deviation 7.94
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 2
Day 3
|
66.7 Beats per minute
Standard Deviation 11.28
|
64.9 Beats per minute
Standard Deviation 14.16
|
67.4 Beats per minute
Standard Deviation 11.04
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 2
Baseline
|
65.4 Beats per minute
Standard Deviation 12.47
|
64.1 Beats per minute
Standard Deviation 7.70
|
63.8 Beats per minute
Standard Deviation 7.85
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 2
Day 4
|
70.8 Beats per minute
Standard Deviation 12.90
|
68.2 Beats per minute
Standard Deviation 11.25
|
72.6 Beats per minute
Standard Deviation 12.36
|
|
Absolute Values for Vital Sign: Pulse Rate-Part 2
Day 5
|
67.6 Beats per minute
Standard Deviation 11.19
|
69.1 Beats per minute
Standard Deviation 9.11
|
69.6 Beats per minute
Standard Deviation 13.99
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 2
Baseline
|
14.8 Breaths per minute
Standard Deviation 1.20
|
15.3 Breaths per minute
Standard Deviation 2.02
|
13.8 Breaths per minute
Standard Deviation 2.27
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 2
Day 2
|
14.3 Breaths per minute
Standard Deviation 2.27
|
15.4 Breaths per minute
Standard Deviation 1.64
|
14.2 Breaths per minute
Standard Deviation 2.36
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 2
Day 3
|
15.0 Breaths per minute
Standard Deviation 2.00
|
14.5 Breaths per minute
Standard Deviation 1.98
|
14.2 Breaths per minute
Standard Deviation 2.18
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 2
Day 4
|
14.9 Breaths per minute
Standard Deviation 2.38
|
14.0 Breaths per minute
Standard Deviation 3.06
|
14.3 Breaths per minute
Standard Deviation 2.22
|
|
Absolute Values for Vital Sign: Respiratory Rate-Part 2
Day 5
|
13.7 Breaths per minute
Standard Deviation 1.63
|
14.5 Breaths per minute
Standard Deviation 1.61
|
14.6 Breaths per minute
Standard Deviation 1.80
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Absolute Values for Vital Sign: Temperature-Part 2
Baseline
|
36.24 Degrees Celsius
Standard Deviation 0.421
|
36.50 Degrees Celsius
Standard Deviation 0.298
|
36.37 Degrees Celsius
Standard Deviation 0.483
|
|
Absolute Values for Vital Sign: Temperature-Part 2
Day 2
|
36.29 Degrees Celsius
Standard Deviation 0.476
|
36.40 Degrees Celsius
Standard Deviation 0.406
|
36.27 Degrees Celsius
Standard Deviation 0.508
|
|
Absolute Values for Vital Sign: Temperature-Part 2
Day 3
|
36.33 Degrees Celsius
Standard Deviation 0.351
|
36.37 Degrees Celsius
Standard Deviation 0.425
|
36.29 Degrees Celsius
Standard Deviation 0.419
|
|
Absolute Values for Vital Sign: Temperature-Part 2
Day 4
|
36.37 Degrees Celsius
Standard Deviation 0.404
|
36.37 Degrees Celsius
Standard Deviation 0.378
|
36.38 Degrees Celsius
Standard Deviation 0.495
|
|
Absolute Values for Vital Sign: Temperature-Part 2
Day 5
|
36.34 Degrees Celsius
Standard Deviation 0.345
|
36.49 Degrees Celsius
Standard Deviation 0.375
|
36.51 Degrees Celsius
Standard Deviation 0.459
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
DBP; Day 3
|
-1.7 Millimeters of mercury
Standard Deviation 7.46
|
-4.3 Millimeters of mercury
Standard Deviation 4.80
|
—
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
DBP; Day 5
|
-2.1 Millimeters of mercury
Standard Deviation 7.46
|
-4.6 Millimeters of mercury
Standard Deviation 7.17
|
—
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
SBP; Day 2
|
-4.5 Millimeters of mercury
Standard Deviation 7.52
|
-2.3 Millimeters of mercury
Standard Deviation 7.22
|
—
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
SBP; Day 3
|
-4.7 Millimeters of mercury
Standard Deviation 9.63
|
-4.1 Millimeters of mercury
Standard Deviation 9.63
|
—
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
SBP; Day 4
|
-6.1 Millimeters of mercury
Standard Deviation 7.45
|
-3.4 Millimeters of mercury
Standard Deviation 10.18
|
—
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
SBP; Day 5
|
-6.1 Millimeters of mercury
Standard Deviation 7.49
|
-3.6 Millimeters of mercury
Standard Deviation 11.37
|
—
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
DBP; Day 2
|
-2.0 Millimeters of mercury
Standard Deviation 6.82
|
-2.2 Millimeters of mercury
Standard Deviation 5.78
|
—
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 1
DBP; Day 4
|
-1.9 Millimeters of mercury
Standard Deviation 6.98
|
-4.7 Millimeters of mercury
Standard Deviation 6.99
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 1
Day 4
|
1.7 Beats per minute
Standard Deviation 6.93
|
-0.6 Beats per minute
Standard Deviation 7.88
|
—
|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 1
Day 2
|
1.1 Beats per minute
Standard Deviation 5.76
|
2.2 Beats per minute
Standard Deviation 7.50
|
—
|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 1
Day 3
|
1.8 Beats per minute
Standard Deviation 8.20
|
2.4 Beats per minute
Standard Deviation 7.41
|
—
|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 1
Day 5
|
-1.3 Beats per minute
Standard Deviation 5.46
|
0.8 Beats per minute
Standard Deviation 10.70
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 1
Day 2; n=17, 17
|
-1.1 Breaths per minute
Standard Deviation 3.47
|
-0.8 Breaths per minute
Standard Deviation 3.00
|
—
|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 1
Day 4; n=18, 18
|
-0.1 Breaths per minute
Standard Deviation 2.78
|
-0.2 Breaths per minute
Standard Deviation 3.35
|
—
|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 1
Day 3; n=17, 18
|
0.6 Breaths per minute
Standard Deviation 2.62
|
0.3 Breaths per minute
Standard Deviation 3.58
|
—
|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 1
Day 5; n=18, 18
|
0.0 Breaths per minute
Standard Deviation 2.74
|
-0.8 Breaths per minute
Standard Deviation 2.76
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Temperature-Part 1
Day 2
|
-0.03 Degrees Celsius
Standard Deviation 0.329
|
0.02 Degrees Celsius
Standard Deviation 0.472
|
—
|
|
Change From Baseline in Vital Sign: Temperature-Part 1
Day 3
|
0.09 Degrees Celsius
Standard Deviation 0.442
|
-0.15 Degrees Celsius
Standard Deviation 0.444
|
—
|
|
Change From Baseline in Vital Sign: Temperature-Part 1
Day 4
|
0.13 Degrees Celsius
Standard Deviation 0.452
|
-0.02 Degrees Celsius
Standard Deviation 0.458
|
—
|
|
Change From Baseline in Vital Sign: Temperature-Part 1
Day 5
|
-0.04 Degrees Celsius
Standard Deviation 0.501
|
-0.11 Degrees Celsius
Standard Deviation 0.330
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Blood pressure was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
SBP, Day 2
|
-3.5 Millimeters of mercury
Standard Deviation 10.50
|
1.5 Millimeters of mercury
Standard Deviation 6.59
|
-1.7 Millimeters of mercury
Standard Deviation 7.65
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
SBP, Day 3
|
-5.1 Millimeters of mercury
Standard Deviation 12.99
|
2.1 Millimeters of mercury
Standard Deviation 7.74
|
-0.9 Millimeters of mercury
Standard Deviation 9.11
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
DBP, Day 4
|
-2.9 Millimeters of mercury
Standard Deviation 8.53
|
2.2 Millimeters of mercury
Standard Deviation 6.27
|
-1.3 Millimeters of mercury
Standard Deviation 6.63
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
SBP, Day 4
|
-1.9 Millimeters of mercury
Standard Deviation 12.28
|
0.3 Millimeters of mercury
Standard Deviation 6.10
|
0.6 Millimeters of mercury
Standard Deviation 9.95
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
SBP, Day 5
|
-2.6 Millimeters of mercury
Standard Deviation 11.23
|
0.7 Millimeters of mercury
Standard Deviation 8.28
|
0.6 Millimeters of mercury
Standard Deviation 7.71
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
DBP, Day 2
|
-2.4 Millimeters of mercury
Standard Deviation 6.10
|
2.8 Millimeters of mercury
Standard Deviation 5.07
|
-0.7 Millimeters of mercury
Standard Deviation 4.90
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
DBP, Day 3
|
-1.9 Millimeters of mercury
Standard Deviation 6.40
|
1.5 Millimeters of mercury
Standard Deviation 7.83
|
0.6 Millimeters of mercury
Standard Deviation 4.95
|
|
Change From Baseline in Vital Signs: SBP and DBP-Part 2
DBP, Day 5
|
-2.9 Millimeters of mercury
Standard Deviation 6.19
|
0.9 Millimeters of mercury
Standard Deviation 6.99
|
-3.0 Millimeters of mercury
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Pulse rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 2
Day 2
|
1.5 Beats per minute
Standard Deviation 7.39
|
-0.1 Beats per minute
Standard Deviation 8.02
|
0.3 Beats per minute
Standard Deviation 4.72
|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 2
Day 3
|
1.3 Beats per minute
Standard Deviation 9.69
|
0.9 Beats per minute
Standard Deviation 13.16
|
3.7 Beats per minute
Standard Deviation 6.59
|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 2
Day 4
|
5.4 Beats per minute
Standard Deviation 10.17
|
4.1 Beats per minute
Standard Deviation 9.64
|
8.9 Beats per minute
Standard Deviation 8.21
|
|
Change From Baseline in Vital Sign: Pulse Rate-Part 2
Day 5
|
2.2 Beats per minute
Standard Deviation 6.39
|
5.0 Beats per minute
Standard Deviation 8.37
|
5.9 Beats per minute
Standard Deviation 8.43
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 2
Day 2
|
-0.5 Breaths per minute
Standard Deviation 2.24
|
0.1 Breaths per minute
Standard Deviation 2.62
|
0.4 Breaths per minute
Standard Deviation 2.58
|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 2
Day 3
|
0.2 Breaths per minute
Standard Deviation 2.42
|
-0.7 Breaths per minute
Standard Deviation 2.42
|
0.4 Breaths per minute
Standard Deviation 3.61
|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 2
Day 4
|
0.1 Breaths per minute
Standard Deviation 2.20
|
-1.3 Breaths per minute
Standard Deviation 3.72
|
0.5 Breaths per minute
Standard Deviation 2.27
|
|
Change From Baseline in Vital Sign: Respiratory Rate-Part 2
Day 5
|
-1.1 Breaths per minute
Standard Deviation 1.77
|
-0.7 Breaths per minute
Standard Deviation 1.91
|
0.8 Breaths per minute
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose), Days 2, 3, 4 and 5Population: Safety Population
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the latest predose assessment with a non-missing value, including those from unscheduled visits, within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=19 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Change From Baseline in Vital Sign: Temperature-Part 2
Day 4
|
0.13 Degrees Celsius
Standard Deviation 0.490
|
-0.13 Degrees Celsius
Standard Deviation 0.268
|
0.01 Degrees Celsius
Standard Deviation 0.399
|
|
Change From Baseline in Vital Sign: Temperature-Part 2
Day 5
|
0.10 Degrees Celsius
Standard Deviation 0.426
|
-0.01 Degrees Celsius
Standard Deviation 0.375
|
0.15 Degrees Celsius
Standard Deviation 0.437
|
|
Change From Baseline in Vital Sign: Temperature-Part 2
Day 2
|
0.05 Degrees Celsius
Standard Deviation 0.477
|
-0.10 Degrees Celsius
Standard Deviation 0.325
|
-0.10 Degrees Celsius
Standard Deviation 0.390
|
|
Change From Baseline in Vital Sign: Temperature-Part 2
Day 3
|
0.09 Degrees Celsius
Standard Deviation 0.302
|
-0.13 Degrees Celsius
Standard Deviation 0.245
|
-0.08 Degrees Celsius
Standard Deviation 0.453
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Lag Time for Absorption (Tlag) for GSK3640254-Part 1
|
0.528 Hours
Standard Deviation 0.7568
|
0.139 Hours
Standard Deviation 0.4132
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Apparent Terminal Phase Half-life (t1/2) for GSK3640254-Part 1
|
26.247 Hours
Geometric Coefficient of Variation 17.6
|
26.185 Hours
Geometric Coefficient of Variation 17.2
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Apparent Oral Clearance (CL/F) for GSK3640254-Part 1
|
5.413 Liters per hour
Geometric Coefficient of Variation 42.7
|
5.423 Liters per hour
Geometric Coefficient of Variation 40.3
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) for GSK3640254-Part 1
|
205.0 Liters
Geometric Coefficient of Variation 40.0
|
204.9 Liters
Geometric Coefficient of Variation 43.0
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 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 Concentration Population comprised of all participants who underwent plasma PK sampling and had evaluable PK assay results.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Plasma Concentration of GSK3640254-Part 1
pre-dose
|
1.910 Nanograms per milliliter
Interval 0.0 to 44.1
|
1.580 Nanograms per milliliter
Interval 0.0 to 31.5
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
1 hour
|
6.795 Nanograms per milliliter
Interval 0.0 to 80.8
|
81.90 Nanograms per milliliter
Interval 0.0 to 842.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
1.5 hours
|
26.40 Nanograms per milliliter
Interval 0.0 to 421.0
|
291.0 Nanograms per milliliter
Interval 0.0 to 1650.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
2 hours
|
104.5 Nanograms per milliliter
Interval 0.0 to 991.0
|
502.5 Nanograms per milliliter
Interval 28.1 to 2160.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
2.5 hours
|
342.5 Nanograms per milliliter
Interval 0.0 to 1500.0
|
804.0 Nanograms per milliliter
Interval 103.0 to 2610.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
3 hours
|
563.5 Nanograms per milliliter
Interval 16.7 to 1780.0
|
965.0 Nanograms per milliliter
Interval 321.0 to 2210.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
3.5 hours
|
724.0 Nanograms per milliliter
Interval 44.3 to 1560.0
|
1105 Nanograms per milliliter
Interval 482.0 to 2190.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
4 hours
|
798.5 Nanograms per milliliter
Interval 80.1 to 1660.0
|
1190 Nanograms per milliliter
Interval 569.0 to 1940.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
4.5 hours
|
964.5 Nanograms per milliliter
Interval 135.0 to 1900.0
|
1270 Nanograms per milliliter
Interval 567.0 to 1890.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
5 hours
|
1047 Nanograms per milliliter
Interval 170.0 to 1840.0
|
1195 Nanograms per milliliter
Interval 479.0 to 1810.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
6 hours
|
1013 Nanograms per milliliter
Interval 385.0 to 1750.0
|
992.0 Nanograms per milliliter
Interval 437.0 to 1710.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
8 hours
|
981.0 Nanograms per milliliter
Interval 298.0 to 1610.0
|
895.0 Nanograms per milliliter
Interval 385.0 to 1500.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
12 hours
|
817.0 Nanograms per milliliter
Interval 253.0 to 1470.0
|
787.0 Nanograms per milliliter
Interval 290.0 to 1210.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
24 hours
|
565.5 Nanograms per milliliter
Interval 162.0 to 889.0
|
582.0 Nanograms per milliliter
Interval 202.0 to 887.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
48 hours
|
286.0 Nanograms per milliliter
Interval 81.9 to 483.0
|
286.0 Nanograms per milliliter
Interval 121.0 to 509.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
72 hours
|
159.0 Nanograms per milliliter
Interval 47.3 to 284.0
|
150.0 Nanograms per milliliter
Interval 75.1 to 271.0
|
—
|
|
Plasma Concentration of GSK3640254-Part 1
96 hours
|
78.10 Nanograms per milliliter
Interval 26.0 to 197.0
|
72.80 Nanograms per milliliter
Interval 34.0 to 172.0
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=13 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Tlag for GSK3640254-Part 2
|
0.050 Hours
Standard Deviation 0.2236
|
0.000 Hours
Standard Deviation 0.0000
|
0.048 Hours
Standard Deviation 0.2182
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=10 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
T1/2 for GSK3640254-Part 2
|
24.921 Hours
Geometric Coefficient of Variation 18.0
|
25.669 Hours
Geometric Coefficient of Variation 12.7
|
24.833 Hours
Geometric Coefficient of Variation 15.7
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=10 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
CL/F for GSK3640254-Part 2
|
4.878 Liter per hour
Geometric Coefficient of Variation 42.2
|
14.85 Liter per hour
Geometric Coefficient of Variation 58.2
|
5.417 Liter per hour
Geometric Coefficient of Variation 35.9
|
SECONDARY outcome
Timeframe: pre-dose, 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 Parameter Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis. PK parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=10 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Vz/F for GSK3640254-Part 2
|
175.4 Liters
Geometric Coefficient of Variation 43.4
|
550.1 Liters
Geometric Coefficient of Variation 66.3
|
194.1 Liters
Geometric Coefficient of Variation 35.9
|
SECONDARY outcome
Timeframe: pre-dose, 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 Concentration Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=20 Participants
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=13 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 Participants
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|
|
Plasma Concentration of GSK3640254-Part 2
24 hours
|
627.5 Nanograms per milliliter
Interval 256.0 to 1150.0
|
177.0 Nanograms per milliliter
Interval 49.9 to 722.0
|
580.0 Nanograms per milliliter
Interval 276.0 to 1070.0
|
|
Plasma Concentration of GSK3640254-Part 2
pre-dose
|
6.370 Nanograms per milliliter
Interval 0.0 to 31.6
|
0 Nanograms per milliliter
Interval 0.0 to 12.8
|
NA Nanograms per milliliter
Interval to 14.7
Median and lower limit could not be calculated as the values were below the lower limit of quantification.
|
|
Plasma Concentration of GSK3640254-Part 2
1 hour
|
39.25 Nanograms per milliliter
Interval 0.0 to 504.0
|
38.70 Nanograms per milliliter
Interval 7.27 to 268.0
|
92.30 Nanograms per milliliter
Interval 0.0 to 1960.0
|
|
Plasma Concentration of GSK3640254-Part 2
1.5 hours
|
306.0 Nanograms per milliliter
Interval 9.18 to 1360.0
|
84.10 Nanograms per milliliter
Interval 18.3 to 496.0
|
239.0 Nanograms per milliliter
Interval 9.88 to 2000.0
|
|
Plasma Concentration of GSK3640254-Part 2
2 hours
|
733.0 Nanograms per milliliter
Interval 37.7 to 1920.0
|
121.0 Nanograms per milliliter
Interval 23.9 to 648.0
|
574.0 Nanograms per milliliter
Interval 27.0 to 1790.0
|
|
Plasma Concentration of GSK3640254-Part 2
2.5 hours
|
1075 Nanograms per milliliter
Interval 193.0 to 2320.0
|
194.0 Nanograms per milliliter
Interval 31.0 to 831.0
|
684.0 Nanograms per milliliter
Interval 65.0 to 1770.0
|
|
Plasma Concentration of GSK3640254-Part 2
3 hours
|
1195 Nanograms per milliliter
Interval 434.0 to 2320.0
|
270.0 Nanograms per milliliter
Interval 34.1 to 1050.0
|
724.0 Nanograms per milliliter
Interval 125.0 to 2040.0
|
|
Plasma Concentration of GSK3640254-Part 2
3.5 hours
|
1250 Nanograms per milliliter
Interval 525.0 to 2310.0
|
326.0 Nanograms per milliliter
Interval 40.0 to 1260.0
|
785.0 Nanograms per milliliter
Interval 212.0 to 2070.0
|
|
Plasma Concentration of GSK3640254-Part 2
4 hours
|
1305 Nanograms per milliliter
Interval 607.0 to 2590.0
|
358.0 Nanograms per milliliter
Interval 58.9 to 1270.0
|
833.0 Nanograms per milliliter
Interval 230.0 to 1910.0
|
|
Plasma Concentration of GSK3640254-Part 2
4.5 hours
|
1245 Nanograms per milliliter
Interval 636.0 to 2330.0
|
324.0 Nanograms per milliliter
Interval 77.4 to 1480.0
|
866.0 Nanograms per milliliter
Interval 272.0 to 1630.0
|
|
Plasma Concentration of GSK3640254-Part 2
5 hours
|
1275 Nanograms per milliliter
Interval 590.0 to 2470.0
|
322.0 Nanograms per milliliter
Interval 71.7 to 1420.0
|
845.0 Nanograms per milliliter
Interval 355.0 to 1620.0
|
|
Plasma Concentration of GSK3640254-Part 2
6 hours
|
1195 Nanograms per milliliter
Interval 528.0 to 2450.0
|
290.0 Nanograms per milliliter
Interval 75.8 to 1350.0
|
968.0 Nanograms per milliliter
Interval 562.0 to 1440.0
|
|
Plasma Concentration of GSK3640254-Part 2
8 hours
|
950.5 Nanograms per milliliter
Interval 457.0 to 2110.0
|
255.0 Nanograms per milliliter
Interval 57.9 to 1160.0
|
845.0 Nanograms per milliliter
Interval 427.0 to 1370.0
|
|
Plasma Concentration of GSK3640254-Part 2
12 hours
|
773.0 Nanograms per milliliter
Interval 363.0 to 1730.0
|
217.0 Nanograms per milliliter
Interval 50.6 to 903.0
|
734.0 Nanograms per milliliter
Interval 376.0 to 1420.0
|
|
Plasma Concentration of GSK3640254-Part 2
48 hours
|
335.5 Nanograms per milliliter
Interval 123.0 to 533.0
|
98.60 Nanograms per milliliter
Interval 35.4 to 327.0
|
287.0 Nanograms per milliliter
Interval 149.0 to 683.0
|
|
Plasma Concentration of GSK3640254-Part 2
72 hours
|
171.5 Nanograms per milliliter
Interval 57.7 to 292.0
|
52.50 Nanograms per milliliter
Interval 28.3 to 153.0
|
145.0 Nanograms per milliliter
Interval 68.0 to 375.0
|
|
Plasma Concentration of GSK3640254-Part 2
96 hours
|
79.75 Nanograms per milliliter
Interval 26.4 to 203.0
|
31.30 Nanograms per milliliter
Interval 14.8 to 80.7
|
62.20 Nanograms per milliliter
Interval 35.9 to 224.0
|
Adverse Events
Part 1: GSK3640254 200 mg Capsules
Part 1: GSK3640254 200 mg Tablets
Part 2: GSK3640254 200 mg Tablet (Moderate Fat)
Part 2: GSK3640254 200 mg Tablet (Fasted)
Part 2: GSK3640254 200 mg Tablet (High Fat)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: GSK3640254 200 mg Capsules
n=18 participants at risk
Participants were administered a single dose of GSK3640254 200 mg capsules, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 1: GSK3640254 200 mg Tablets
n=18 participants at risk
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1 or 2.
|
Part 2: GSK3640254 200 mg Tablet (Moderate Fat)
n=20 participants at risk
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under moderate fat conditions on Day 1 in Period 1, 2 or 3.
|
Part 2: GSK3640254 200 mg Tablet (Fasted)
n=19 participants at risk
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under fasted conditions on Day 1 in Period 1, 2 or 3.
|
Part 2: GSK3640254 200 mg Tablet (High Fat)
n=21 participants at risk
Participants were administered a single dose of GSK3640254 200 mg tablets, orally under high fat conditions on Day 1 in Period 1, 2 or 3.
|
|---|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/18 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
5.6%
1/18 • Number of events 1 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
0.00%
0/20 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
0.00%
0/19 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
0.00%
0/21 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
0.00%
0/18 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
0.00%
0/20 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
0.00%
0/19 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
9.5%
2/21 • Number of events 2 • Up to Day 12 for Part 1 and up to Day 19 for Part 2
AEs and SAEs were collected in the Safety Population which comprised of all participants who received at least 1 dose of study medication. Data is presented treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER