Trial Outcomes & Findings for A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses (NCT NCT03266172)
NCT ID: NCT03266172
Last Updated: 2021-08-13
Results Overview
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Participants in the 'Safety Population' for whom a Pharmacokinetic (PK) sample was obtained and analyzed were part of PK Population.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose
Results posted on
2021-08-13
Participant Flow
This was an open label, 3-part, single and repeat dose study conducted in healthy participants to assess modified release (MR) minitablets (MT) in a capsule and MR monolithic matrix (MM) formulations of GSK2982772 compared to immediate release (IR) tablet formulation of GSK2982772.
In this study, total 45 participants were enrolled.
Participant milestones
| Measure |
MT-12hr Fasted/MT-8hr Fasted/IR Fasted/MT-12hr Fed (High Fat)
Participants in Part A received a single dose of 120 mg GSK2982772 MR MT-12hour (hr) capsule (80% release at 12 hours) in fasted state in Period 1 followed by a single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state in Period 2. In Period 3, participants received a single oral dose of 120 milligram (mg) GSK2982772 (4x30 mg) IR tablet in fasted state followed by a single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal in Period 4. There was a washout period of 7 days between each treatment period. All doses were administered via the oral route with 240 milliliters (mL) of water.
|
MT 120mg Fasted/MT 240mg Fasted/ MT 300mg Fed (Standard)
Participants in Part B received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 1 followed by once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 2. In Period 3, participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days. There was washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water.
|
MM240 Fast/IR240 Fast/MM480 Fast/MM480 Fed/MM480 DF/MM240 DF
Participants in Part C received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted (Fast) state in Period 1 followed by a single dose of 240 mg GSK2982772 IR tablet in fasted state in Period 2. In Period 3, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. In Period 4, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state followed by a single dose of 480 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before standard breakfast (delayed fed \[DF\]) in Period 5. In Period 6, participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (DF). There was a washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water
|
|---|---|---|---|
|
Part A: Period 1(2 Days)
STARTED
|
16
|
0
|
0
|
|
Part A: Period 1(2 Days)
COMPLETED
|
15
|
0
|
0
|
|
Part A: Period 1(2 Days)
NOT COMPLETED
|
1
|
0
|
0
|
|
Part A: Washout Period (7 Days)
STARTED
|
15
|
0
|
0
|
|
Part A: Washout Period (7 Days)
COMPLETED
|
13
|
0
|
0
|
|
Part A: Washout Period (7 Days)
NOT COMPLETED
|
2
|
0
|
0
|
|
Part A: Period 2 (2 Days)
STARTED
|
13
|
0
|
0
|
|
Part A: Period 2 (2 Days)
COMPLETED
|
13
|
0
|
0
|
|
Part A: Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part A: Washout (7 Days)
STARTED
|
16
|
0
|
0
|
|
Part A: Washout (7 Days)
COMPLETED
|
16
|
0
|
0
|
|
Part A: Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part A: Period 3 (2 Days)
STARTED
|
16
|
0
|
0
|
|
Part A: Period 3 (2 Days)
COMPLETED
|
16
|
0
|
0
|
|
Part A: Period 3 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part A: Period 4 (2 Days)
STARTED
|
16
|
0
|
0
|
|
Part A: Period 4 (2 Days)
COMPLETED
|
16
|
0
|
0
|
|
Part A: Period 4 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B: Period 1 (4 Days)
STARTED
|
0
|
10
|
0
|
|
Part B: Period 1 (4 Days)
COMPLETED
|
0
|
10
|
0
|
|
Part B: Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B: Washout (7 Days)
STARTED
|
0
|
10
|
0
|
|
Part B: Washout (7 Days)
COMPLETED
|
0
|
8
|
0
|
|
Part B: Washout (7 Days)
NOT COMPLETED
|
0
|
2
|
0
|
|
Part B: Period 2 (4 Days)
STARTED
|
0
|
10
|
0
|
|
Part B: Period 2 (4 Days)
COMPLETED
|
0
|
10
|
0
|
|
Part B: Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B: Period 3 (4 Days)
STARTED
|
0
|
6
|
0
|
|
Part B: Period 3 (4 Days)
COMPLETED
|
0
|
6
|
0
|
|
Part B: Period 3 (4 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part C: Period 1(2 Days)
STARTED
|
0
|
0
|
15
|
|
Part C: Period 1(2 Days)
COMPLETED
|
0
|
0
|
15
|
|
Part C: Period 1(2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part C Washout Period (7 Days)
STARTED
|
0
|
0
|
15
|
|
Part C Washout Period (7 Days)
COMPLETED
|
0
|
0
|
14
|
|
Part C Washout Period (7 Days)
NOT COMPLETED
|
0
|
0
|
1
|
|
Part C Period 2(2 Days)
STARTED
|
0
|
0
|
15
|
|
Part C Period 2(2 Days)
COMPLETED
|
0
|
0
|
15
|
|
Part C Period 2(2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part C Period 3(2 Days)
STARTED
|
0
|
0
|
16
|
|
Part C Period 3(2 Days)
COMPLETED
|
0
|
0
|
16
|
|
Part C Period 3(2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part C Period 4(2 Days)
STARTED
|
0
|
0
|
16
|
|
Part C Period 4(2 Days)
COMPLETED
|
0
|
0
|
16
|
|
Part C Period 4(2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part C Period 5(2 Days)
STARTED
|
0
|
0
|
15
|
|
Part C Period 5(2 Days)
COMPLETED
|
0
|
0
|
15
|
|
Part C Period 5(2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part C Period 6(2 Days)
STARTED
|
0
|
0
|
14
|
|
Part C Period 6(2 Days)
COMPLETED
|
0
|
0
|
14
|
|
Part C Period 6(2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
MT-12hr Fasted/MT-8hr Fasted/IR Fasted/MT-12hr Fed (High Fat)
Participants in Part A received a single dose of 120 mg GSK2982772 MR MT-12hour (hr) capsule (80% release at 12 hours) in fasted state in Period 1 followed by a single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state in Period 2. In Period 3, participants received a single oral dose of 120 milligram (mg) GSK2982772 (4x30 mg) IR tablet in fasted state followed by a single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal in Period 4. There was a washout period of 7 days between each treatment period. All doses were administered via the oral route with 240 milliliters (mL) of water.
|
MT 120mg Fasted/MT 240mg Fasted/ MT 300mg Fed (Standard)
Participants in Part B received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 1 followed by once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 2. In Period 3, participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days. There was washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water.
|
MM240 Fast/IR240 Fast/MM480 Fast/MM480 Fed/MM480 DF/MM240 DF
Participants in Part C received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted (Fast) state in Period 1 followed by a single dose of 240 mg GSK2982772 IR tablet in fasted state in Period 2. In Period 3, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. In Period 4, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state followed by a single dose of 480 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before standard breakfast (delayed fed \[DF\]) in Period 5. In Period 6, participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (DF). There was a washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water
|
|---|---|---|---|
|
Part A: Period 1(2 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
|
Part A: Washout Period (7 Days)
Adverse Event
|
1
|
0
|
0
|
|
Part A: Washout Period (7 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
|
Part B: Washout (7 Days)
Withdrawal by Subject
|
0
|
2
|
0
|
|
Part C Washout Period (7 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses
Baseline characteristics by cohort
| Measure |
MT-12hr Fasted/MT-8hr Fasted/IR Fasted/MT-12hr Fed (High Fat)
n=19 Participants
Participants in Part A received a single dose of 120 mg GSK2982772 MR MT-12hour (hr) capsule (80% release at 12 hours) in fasted state in Period 1 followed by a single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state in Period 2. In Period 3, participants received a single oral dose of 120 milligram (mg) GSK2982772 (4x30 mg) IR tablet in fasted state followed by a single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal in Period 4. There was a washout period of 7 days between each treatment period. All doses were administered via the oral route with 240 milliliters (mL) of water.
|
MT 120mg Fasted/MT 240mg Fasted/ MT 300mg Fed (Standard)
n=10 Participants
Participants in Part B received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 1 followed by once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days in Period 2. In Period 3, participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days. There was washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water.
|
MM240 Fast/IR240 Fast/MM480 Fast/MM480 Fed/MM480 DF/MM240 DF
n=16 Participants
Participants in Part C received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted (Fast) state in Period 1 followed by a single dose of 240 mg GSK2982772 IR tablet in fasted state in Period 2. In Period 3, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state. In Period 4, participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state followed by a single dose of 480 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before standard breakfast (delayed fed \[DF\]) in Period 5. In Period 6, participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours) before high-fat breakfast (delayed fed). There was a washout period of 7 days between each treatment period. All doses were administered via oral route with 240 mL water
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.2 Years
STANDARD_DEVIATION 14.10 • n=5 Participants
|
47.8 Years
STANDARD_DEVIATION 13.43 • n=7 Participants
|
45.3 Years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
47.5 Years
STANDARD_DEVIATION 13.12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Participants in the 'Safety Population' for whom a Pharmacokinetic (PK) sample was obtained and analyzed were part of PK Population.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 in IR Formulation: Part A
|
6.305 Hours*microgram per milliliter
Geometric Coefficient of Variation 39.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only those participants with data available at specified time frame were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf).
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=10 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-inf) of GSK2982772 in MT Formulation :Part A
|
3.852 Hours*microgram per milliliter
Geometric Coefficient of Variation 39.4
|
4.482 Hours*microgram per milliliter
Geometric Coefficient of Variation 47.4
|
5.314 Hours*microgram per milliliter
Geometric Coefficient of Variation 39.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 in IR Formulation : Part A
|
6.258 Hours*microgram per milliliter
Geometric Coefficient of Variation 39.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only those participants with data available at specified time frame were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-t) of GSK2982772 in MT Formulation: Part A
|
3.805 Hours*microgram per milliliter
Geometric Coefficient of Variation 42.3
|
4.449 Hours*microgram per milliliter
Geometric Coefficient of Variation 49.4
|
4.720 Hours*microgram per milliliter
Geometric Coefficient of Variation 38.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 in IR Formulation: Part A
|
6.256 Hours*microgram per milliliter
Geometric Coefficient of Variation 39.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only those participants with data available at specified time frame were analyzed
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-24) of GSK2982772 in MT Formulation: Part A
|
3.558 Hours*microgram per milliliter
Geometric Coefficient of Variation 43.6
|
4.255 Hours*microgram per milliliter
Geometric Coefficient of Variation 49.4
|
4.580 Hours*microgram per milliliter
Geometric Coefficient of Variation 39.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-12)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to 12 Hours (AUC[0-12]) of GSK2982772 in IR Formulation: Part A
|
5.967 Hours*microgram per milliliter
Geometric Coefficient of Variation 38.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-12)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-12) of GSK2982772 in MT Formulation: Part A
|
2.106 Hours*microgram per milliliter
Geometric Coefficient of Variation 45.1
|
3.066 Hours*microgram per milliliter
Geometric Coefficient of Variation 47.7
|
3.573 Hours*microgram per milliliter
Geometric Coefficient of Variation 40.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population
Blood samples were collected from participants at indicated time points and analyzed for Cmax
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of GSK2982772 in IR Formulation: Part A
|
1.375 Microgram per milliliter
Geometric Coefficient of Variation 40.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for Cmax
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Cmax of GSK2982772 in MT Formulation: Part A
|
0.277 Microgram per milliliter
Geometric Coefficient of Variation 58.8
|
0.439 Microgram per milliliter
Geometric Coefficient of Variation 54.9
|
0.624 Microgram per milliliter
Geometric Coefficient of Variation 49.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for C12hour.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A
|
0.220 Microgram per milliliter
Geometric Coefficient of Variation 52.6
|
0.209 Microgram per milliliter
Geometric Coefficient of Variation 56.2
|
0.208 Microgram per milliliter
Geometric Coefficient of Variation 53.1
|
0.045 Microgram per milliliter
Geometric Coefficient of Variation 81.7
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for C24hour.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A
|
0.058 Microgram per milliliter
Geometric Coefficient of Variation 73.2
|
0.046 Microgram per milliliter
Geometric Coefficient of Variation 69.5
|
0.030 Microgram per milliliter
Geometric Coefficient of Variation 46.6
|
0.006 Microgram per milliliter
Geometric Coefficient of Variation 108.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose (test)Population: PK Population. Only those participants with data available at specified time frame were analyzed.
Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT (test) / Geometric mean of AUC (0-inf) of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part A
|
72.77 Percentage bioavailability
Interval 67.91 to 77.98
|
60.53 Percentage bioavailability
Interval 56.15 to 65.24
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose (test)Population: PK Population. Only those participants with data available at specified time frame were analyzed.
Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MT (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=13 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on AUC (0-24) of GSK2982772 in Part A
|
68.18 Percentage bioavailability
Interval 63.98 to 72.64
|
57.54 Percentage bioavailability
Interval 54.01 to 61.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose(test)Population: PK Population. Only those participants with data available at specified time frame were analyzed.
Blood samples were collected at indicated time points for analysis of Frelformulation. Frel was calculated as Geometric mean of Cmax of MT Formulation (test)/ Geometric mean of Cmax of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=13 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on Cmax of GSK2982772 in Part A
|
32.13 Percentage bioavailability
Interval 27.36 to 37.75
|
20.39 Percentage bioavailability
Interval 17.41 to 23.89
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C12hour of GSK2982772 in IR Formulation: Part A
|
36.485 Ratio
Standard Deviation 20.9265
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A
|
1.284 Ratio
Standard Deviation 0.2468
|
2.265 Ratio
Standard Deviation 0.9119
|
3.240 Ratio
Standard Deviation 1.2250
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C24hour of GSK2982772 in IR Formulation: Part A
|
312.851 Ratio
Standard Deviation 221.7640
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A
|
6.119 Ratio
Standard Deviation 5.1507
|
10.790 Ratio
Standard Deviation 4.9019
|
22.915 Ratio
Standard Deviation 11.7978
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of Tmax.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of GSK2982772 in IR Formulation: Part A
|
2.000 Hours
Interval 0.67 to 3.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of Tmax.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=15 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Tmax of GSK2982772 in MT Formulation: Part A
|
10.000 Hours
Interval 2.08 to 18.0
|
4.000 Hours
Interval 4.0 to 10.0
|
6.000 Hours
Interval 4.0 to 10.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of AUC (0-inf)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=14 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-inf) of GSK2982772 for IR Formulation in Part C: Fasted State
|
14.797 Hours*microgram per milliliter
Geometric Coefficient of Variation 26.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of AUC (0-inf).
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=4 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=4 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted State
|
13.417 Hours*microgram per milliliter
Geometric Coefficient of Variation 23.4
|
22.493 Hours*microgram per milliliter
Geometric Coefficient of Variation 51.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at specified time frame were analyzed.
Blood samples were collected at indicated time points for analysis of AUC (0-t).
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-t) of GSK2982772 for IR Formulation in Part C: Fasted State
|
14.621 Hours*microgram per milliliter
Geometric Coefficient of Variation 25.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of AUC (0-t).
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted State
|
9.676 Hours*microgram per milliliter
Geometric Coefficient of Variation 29.6
|
20.009 Hours*microgram per milliliter
Geometric Coefficient of Variation 29.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of AUC (0-24)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-24) of GSK2982772 for IR Formulation in Part C: Fasted State
|
14.619 Hours*microgram per milliliter
Geometric Coefficient of Variation 25.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of AUC (0-24)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted State
|
8.769 Hours*microgram per milliliter
Geometric Coefficient of Variation 30.9
|
18.177 Hours*microgram per milliliter
Geometric Coefficient of Variation 31.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of AUC (0-12)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC (0-12) of GSK2982772 for IR Formulation in Part C: Fasted State
|
13.500 Hours*microgram per milliliter
Geometric Coefficient of Variation 26.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of AUC (0-12)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted State
|
6.096 Hours*microgram per milliliter
Geometric Coefficient of Variation 32.8
|
12.508 Hours*microgram per milliliter
Geometric Coefficient of Variation 40.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Cmax
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Cmax of GSK2982772 for IR Formulation in Part C: Fasted State
|
2.938 Microgram per milliliter
Geometric Coefficient of Variation 25.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Cmax
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Cmax of GSK2982772 for MM Formulation in Part C: Fasted State
|
0.918 Microgram per milliliter
Geometric Coefficient of Variation 34.2
|
2.010 Microgram per milliliter
Geometric Coefficient of Variation 50.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 hours post-dosePopulation: PK Population.
Blood samples was collected at indicated time point for analysis of C12
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
C12 of GSK2982772 in Part C: Fasted State
|
0.197 Microgram per milliliter
Geometric Coefficient of Variation 62.9
|
0.346 Microgram per milliliter
Geometric Coefficient of Variation 41.7
|
0.671 Microgram per milliliter
Geometric Coefficient of Variation 42.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: PK Population.
Blood samples was collected at indicated time point for analysis of C24
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
C24 of GSK2982772 in Part C: Fasted State
|
0.025 Microgram per milliliter
Geometric Coefficient of Variation 54.9
|
0.162 Microgram per milliliter
Geometric Coefficient of Variation 52.6
|
0.351 Microgram per milliliter
Geometric Coefficient of Variation 52.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C12hour of GSK2982772 for IR Formulation in Part C: Fasted State
|
17.158 Ratio
Standard Deviation 7.9158
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State
|
2.892 Ratio
Standard Deviation 1.2572
|
3.551 Ratio
Standard Deviation 2.2615
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C24hour of GSK2982772 for IR Formulation in Part C: Fasted State
|
138.239 Ratio
Standard Deviation 76.3996
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Ratio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State
|
6.026 Ratio
Standard Deviation 2.1936
|
7.991 Ratio
Standard Deviation 10.6319
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose(test)Population: PK Population.
Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MM formulation (test) / Geometric mean of AUC (0-t) of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on AUC (0-t) of GSK2982772 in Part C: Fasted State
|
66.18 Percentage bioavailability
Interval 61.91 to 70.74
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dose(test)Population: PK Population. Only those participants with data available at the specified data points were analyzed
Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MM Fasted formulation (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on AUC (0-24) of GSK2982772 in Part C: Fasted State
|
59.98 Percentage bioavailability
Interval 55.06 to 65.34
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after a high fat meal. Frel for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT Fed formulation (test) / Geometric mean of AUC (0-inf) of MT Fasted Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on AUC (0-inf) of GSK2982772 After a High Fat Meal in Part A
|
123.64 Percentage bioavailability
Interval 115.98 to 131.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only those participants with data available at specified timepoint were analyzed
Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772 after a high fat meal. Frel for Cmax was calculated as Geometric mean of Cmax of MT Fed formulation (test) / Geometric mean of Cmax of MT Fasted Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on Cmax of GSK2982772 After a High Fat Meal in Part A
|
225.07 Percentage bioavailability
Interval 201.78 to 251.04
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected at indicated time points for analysis of AUC (0-24)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-24) of GSK2982772 in Part B
Day 1, n=10, 9, 5
|
4.669 Hours*microgram/milliliter
Geometric Coefficient of Variation 26.5
|
8.807 Hours*microgram/milliliter
Geometric Coefficient of Variation 34.3
|
9.662 Hours*microgram/milliliter
Geometric Coefficient of Variation 33.8
|
—
|
—
|
—
|
|
AUC(0-24) of GSK2982772 in Part B
Day 3, n=10, 10, 6
|
5.010 Hours*microgram/milliliter
Geometric Coefficient of Variation 32.0
|
9.867 Hours*microgram/milliliter
Geometric Coefficient of Variation 30.4
|
10.948 Hours*microgram/milliliter
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3Population: PK Population.
Blood samples were collected at indicated time points for analysis of Cmax
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Cmax of GSK2982772 in Part B
Day 1
|
0.417 Microgram/milliliter
Geometric Coefficient of Variation 25.5
|
0.707 Microgram/milliliter
Geometric Coefficient of Variation 44.7
|
0.888 Microgram/milliliter
Geometric Coefficient of Variation 14.1
|
—
|
—
|
—
|
|
Cmax of GSK2982772 in Part B
Day 3
|
0.398 Microgram/milliliter
Geometric Coefficient of Variation 32.9
|
0.794 Microgram/milliliter
Geometric Coefficient of Variation 35.7
|
1.080 Microgram/milliliter
Geometric Coefficient of Variation 40.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3Population: PK Population.
Blood samples were collected at indicated time points for analysis of Tmax
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Tmax of GSK2982772 in Part B
Day 1
|
4.058 Hours
Interval 4.0 to 10.0
|
4.067 Hours
Interval 4.0 to 12.0
|
4.000 Hours
Interval 4.0 to 10.0
|
—
|
—
|
—
|
|
Tmax of GSK2982772 in Part B
Day 3
|
4.000 Hours
Interval 2.0 to 16.0
|
5.025 Hours
Interval 4.0 to 20.0
|
4.000 Hours
Interval 4.0 to 6.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of AUC (0-24)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=14 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC (0-24) of GSK2982772 After Meal in Part C
|
17.505 Hours*microgram/milliliter
Geometric Coefficient of Variation 29.5
|
8.734 Hours*microgram/milliliter
Geometric Coefficient of Variation 47.4
|
21.543 Hours*microgram/milliliter
Geometric Coefficient of Variation 39.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hoursPopulation: PK Population
Blood samples were collected at indicated time points for analysis of Cmax
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=14 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Cmax of GSK2982772 After Meal in Part C
|
1.547 Microgram/milliliter
Geometric Coefficient of Variation 40.8
|
1.064 Microgram/milliliter
Geometric Coefficient of Variation 62.6
|
3.151 Microgram/milliliter
Geometric Coefficient of Variation 32.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of C12
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=14 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=14 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
C12 of GSK2982772 After Meal in Part C
|
0.706 Microgram/milliliter
Geometric Coefficient of Variation 72.7
|
0.739 Microgram/milliliter
Geometric Coefficient of Variation 37.1
|
0.317 Microgram/milliliter
Geometric Coefficient of Variation 49.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of AUC (0-t)
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=14 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-t) of GSK2982772 After Meal in Part C
|
19.147 Hours*microgram/milliliter
Geometric Coefficient of Variation 28.0
|
9.202 Hours*microgram/milliliter
Geometric Coefficient of Variation 46.4
|
22.712 Hours*microgram/milliliter
Geometric Coefficient of Variation 36.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population. Only participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for analysis of AUC (0-inf) after meal.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=7 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=6 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=5 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-inf) of GSK2982772 After Meal in Part C
|
18.941 Hours*microgram/milliliter
Geometric Coefficient of Variation 36.5
|
9.995 Hours*microgram/milliliter
Geometric Coefficient of Variation 62.4
|
24.367 Hours*microgram/milliliter
Geometric Coefficient of Variation 49.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, and 12 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of AUC (0-12) after meal.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=14 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
AUC(0-12) of GSK2982772 After Meal in Part C
|
17.111 Hours*microgram/milliliter
Geometric Coefficient of Variation 45.0
|
10.241 Hours*microgram/milliliter
Geometric Coefficient of Variation 45.9
|
6.771 Hours*microgram/milliliter
Geometric Coefficient of Variation 56.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after meal. Frel for Auc (0-t) was calculated as Geometric mean of AUC (0-t) of MM Fed formulation (fed) / Geometric mean of AUC (0-t) of MM Fasted Formulation (fasted) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=14 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C
|
94.69 Percentage bioavailability
Interval 87.03 to 103.04
|
113.51 Percentage bioavailability
Interval 104.52 to 123.27
|
91.13 Percentage bioavailability
Interval 82.23 to 100.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 after meal. Frel for Cmax was calculated as Geometric mean of Cmax of MM Fed formulation (test) / Geometric mean of Cmax of MM Fasted Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=14 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Frelformulation Based on Cmax of GSK2982772 After Meal in Part C
|
76.56 Percentage bioavailability
Interval 64.25 to 91.22
|
156.77 Percentage bioavailability
Interval 132.06 to 186.09
|
113.81 Percentage bioavailability
Interval 94.0 to 137.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Tmax of GSK2982772 after meal.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=14 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Tmax of GSK2982772 After Meal in Part C
|
4.000 Hours
Interval 2.0 to 20.0
|
4.000 Hours
Interval 2.0 to 10.02
|
5.017 Hours
Interval 4.0 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before. All participants who receive at least 1 dose of study treatment and were included in Safety Population. Participants will be analyzed according to the treatment they actually received.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=13 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A
Any AEs
|
4 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A
Any SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With AE and SAE in Part B
Any AEs
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With AE and SAE in Part B
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With AE and SAE in Part C
Any AEs
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With AE and SAE in Part C
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
ALT, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
ALT, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
ALT, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Albumin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Albumin, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Albumin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
ALP, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
ALP, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
ALP, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
AST, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
AST, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
AST, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Calcium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Calcium, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Calcium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Creatinine, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Creatinine, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Creatinine, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Glucose, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Glucose, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Glucose, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Potassium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Potassium, normal or no change
|
15 Participants
|
13 Participants
|
16 Participants
|
15 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Potassium, high
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Sodium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Sodium, normal or no change16
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Sodium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Total Bilirubin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Total Bilirubin, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A
Total Bilirubin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Blood samples were collected to analyze hematology parameters like platelet count, white blood cell (WBC) count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Total Neutrophils, normal or no change
|
15 Participants
|
11 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Total Neutrophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
WBC, low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
WBC, normal or no change
|
15 Participants
|
12 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
WBC, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Hematocrit, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Hematocrit, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Hemoglobin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Hemoglobin, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Hemoglobin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Lymphocytes, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Lymphocytes, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Lymphocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Platelet count, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Platelet count, normal or no change
|
16 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Platelet count, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A
Total Neutrophils, low
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants Abnormal Urinalysis Dipstick Results: Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Population
Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
ALT, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
ALT, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
ALT, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Albumin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Albumin, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Albumin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
ALP, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
ALP, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
ALP, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
AST, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
AST, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
AST, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Calcium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Calcium, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Calcium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Creatinine, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Creatinine, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Creatinine, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Glucose, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Glucose, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Glucose, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Potassium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Potassium, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Potassium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Sodium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Sodium, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Sodium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Total Bilirubin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Total Bilirubin, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B
Total Bilirubin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Population
Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Hematocrit, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Hematocrit, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Hemoglobin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Hemoglobin, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Hemoglobin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Lymphocytes, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Lymphocytes, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Lymphocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Platelet count, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Platelet count, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Platelet count, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Total Neutrophils, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Total Neutrophils, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
Total Neutrophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
WBC, low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
WBC, normal or no change
|
10 Participants
|
10 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B
WBC, high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Population
Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants Abnormal Urinalysis Dipstick Results: Part B
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
ALT, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
ALT, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
ALT, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Albumin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Albumin, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Albumin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
ALP, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
ALP, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
ALP, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
AST, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
AST, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
AST, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Calcium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Calcium, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Calcium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Creatinine, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Creatinine, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Creatinine, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Glucose, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Glucose, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Glucose, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Potassium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Potassium, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Potassium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Sodium, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Sodium, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Sodium, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Total Bilirubin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Total Bilirubin, normal or no change
|
15 Participants
|
15 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C
Total Bilirubin, high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Hematocrit, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Hematocrit, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Hematocrit, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Hemoglobin, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Hemoglobin, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Hemoglobin, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Lymphocytes, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Lymphocytes, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Lymphocytes, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Platelet count, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Platelet count, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Platelet count, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Total Neutrophils, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Total Neutrophils, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
Total Neutrophils, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
WBC, low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
WBC, normal or no change
|
15 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
14 Participants
|
|
Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C
WBC, high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants Abnormal Urinalysis Dipstick Results: Part C
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and Corrected QT (QTc) intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=13 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A
Abnormal, not clinically significant
|
6 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A
Abnormal, clinically significant
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Population
Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants Abnormal ECG Findings: Part B
Abnormal, not clinically significant
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Abnormal ECG Findings: Part B
Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 43Population: Safety Population
Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Number of Participants Abnormal ECG Findings: Part C
Abnormal, not clinically significant
|
1 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants Abnormal ECG Findings: Part C
Abnormal, clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=13 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Pressure: Part A
SBP, Day 1, 2 hours, n=16,16, 13,16
|
-1.4 Millimeters of mercury
Standard Deviation 13.46
|
4.3 Millimeters of mercury
Standard Deviation 10.70
|
-0.2 Millimeters of mercury
Standard Deviation 16.53
|
-6.2 Millimeters of mercury
Standard Deviation 11.20
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part A
SBP,Day 1, 12 hours, n=15,16, 13,16
|
-1.6 Millimeters of mercury
Standard Deviation 14.05
|
-2.5 Millimeters of mercury
Standard Deviation 14.27
|
-6.2 Millimeters of mercury
Standard Deviation 12.34
|
-2.9 Millimeters of mercury
Standard Deviation 18.70
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part A
SBP,Day 2, 24 hours, n=16,16, 13,16
|
7.4 Millimeters of mercury
Standard Deviation 13.86
|
-2.7 Millimeters of mercury
Standard Deviation 9.76
|
-6.2 Millimeters of mercury
Standard Deviation 11.22
|
-3.9 Millimeters of mercury
Standard Deviation 14.11
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part A
DBP, Day 1, 2 hours, n=16,16, 13,16
|
0.3 Millimeters of mercury
Standard Deviation 7.33
|
3.0 Millimeters of mercury
Standard Deviation 8.12
|
-1.8 Millimeters of mercury
Standard Deviation 7.81
|
-4.4 Millimeters of mercury
Standard Deviation 8.94
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part A
DBP,Day 1, 12 hours, n=16,16, 13,16
|
-3.9 Millimeters of mercury
Standard Deviation 10.01
|
-3.6 Millimeters of mercury
Standard Deviation 9.87
|
-3.0 Millimeters of mercury
Standard Deviation 9.27
|
-3.9 Millimeters of mercury
Standard Deviation 9.02
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part A
DBP,Day 2, 24 hours, n=16,16, 13,16
|
2.1 Millimeters of mercury
Standard Deviation 8.51
|
0.7 Millimeters of mercury
Standard Deviation 7.60
|
-1.7 Millimeters of mercury
Standard Deviation 7.79
|
-1.1 Millimeters of mercury
Standard Deviation 8.82
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1 Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population.
Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=13 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate: Part A
Day 1, 2 hours
|
-4.4 Beats per minute
Standard Deviation 5.11
|
-0.3 Beats per minute
Standard Deviation 4.88
|
-2.5 Beats per minute
Standard Deviation 7.62
|
3.9 Beats per minute
Standard Deviation 7.48
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part A
Day 1, 12 hours
|
4.8 Beats per minute
Standard Deviation 6.06
|
5.2 Beats per minute
Standard Deviation 3.94
|
5.8 Beats per minute
Standard Deviation 5.57
|
7.5 Beats per minute
Standard Deviation 9.93
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part A
Day 2, 24 hours
|
1.5 Beats per minute
Standard Deviation 9.41
|
-2.1 Beats per minute
Standard Deviation 6.31
|
0.6 Beats per minute
Standard Deviation 7.14
|
0.9 Beats per minute
Standard Deviation 7.62
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population.
Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=13 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Respiration Rate: Part A
Day 1, 2 hours
|
-0.4 Breaths per minute
Standard Deviation 1.67
|
0.8 Breaths per minute
Standard Deviation 1.65
|
0.0 Breaths per minute
Standard Deviation 1.00
|
-1.5 Breaths per minute
Standard Deviation 2.50
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part A
Day 1, 12 hours
|
-0.6 Breaths per minute
Standard Deviation 1.71
|
-0.1 Breaths per minute
Standard Deviation 1.82
|
-0.2 Breaths per minute
Standard Deviation 1.21
|
-2.4 Breaths per minute
Standard Deviation 2.63
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part A
Day 2, 24 hours
|
1.3 Breaths per minute
Standard Deviation 2.15
|
-0.1 Breaths per minute
Standard Deviation 1.54
|
-1.5 Breaths per minute
Standard Deviation 1.51
|
-1.4 Breaths per minute
Standard Deviation 2.13
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population.
Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=16 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=13 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature: Part A
Day 1, 2 hours
|
0.02 Degree Celsius
Standard Deviation 0.152
|
0.18 Degree Celsius
Standard Deviation 0.180
|
0.05 Degree Celsius
Standard Deviation 0.145
|
0.14 Degree Celsius
Standard Deviation 0.126
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part A
Day 1, 12 hours
|
0.07 Degree Celsius
Standard Deviation 0.139
|
-0.04 Degree Celsius
Standard Deviation 0.145
|
0.13 Degree Celsius
Standard Deviation 0.118
|
0.11 Degree Celsius
Standard Deviation 0.173
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part A
Day 2, 24 hours
|
0.04 Degree Celsius
Standard Deviation 0.182
|
0.07 Degree Celsius
Standard Deviation 0.095
|
0.12 Degree Celsius
Standard Deviation 0.114
|
0.12 Degree Celsius
Standard Deviation 0.161
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hoursPopulation: Safety Population
SBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Pressure: Part B
SBP, Day 1, 2 hours
|
-0.5 Millimeters of mercury
Standard Deviation 7.40
|
5.4 Millimeters of mercury
Standard Deviation 7.37
|
1.2 Millimeters of mercury
Standard Deviation 7.08
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
SBP,Day 1, 12 hours
|
2.7 Millimeters of mercury
Standard Deviation 7.75
|
1.5 Millimeters of mercury
Standard Deviation 8.86
|
1.0 Millimeters of mercury
Standard Deviation 10.73
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
SBP,Day 2, Pre-dose
|
-0.1 Millimeters of mercury
Standard Deviation 5.26
|
3.5 Millimeters of mercury
Standard Deviation 7.76
|
1.8 Millimeters of mercury
Standard Deviation 6.62
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
SBP,Day 3, Pre-dose
|
-1.0 Millimeters of mercury
Standard Deviation 9.35
|
1.1 Millimeters of mercury
Standard Deviation 5.09
|
-0.7 Millimeters of mercury
Standard Deviation 14.09
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
SBP,Day 3, 2 hours
|
2.0 Millimeters of mercury
Standard Deviation 8.37
|
5.5 Millimeters of mercury
Standard Deviation 9.51
|
-3.3 Millimeters of mercury
Standard Deviation 9.14
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
SBP,Day 3, 12 hours
|
2.4 Millimeters of mercury
Standard Deviation 11.55
|
7.4 Millimeters of mercury
Standard Deviation 14.17
|
3.8 Millimeters of mercury
Standard Deviation 8.21
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
SBP,Day 4, 24 hours
|
2.9 Millimeters of mercury
Standard Deviation 9.22
|
6.1 Millimeters of mercury
Standard Deviation 5.04
|
6.0 Millimeters of mercury
Standard Deviation 11.24
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
DBP, Day 1, 2 hours
|
2.4 Millimeters of mercury
Standard Deviation 7.31
|
2.1 Millimeters of mercury
Standard Deviation 7.16
|
-4.0 Millimeters of mercury
Standard Deviation 4.20
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
DBP,Day 1, 12 hours
|
-1.7 Millimeters of mercury
Standard Deviation 5.50
|
-2.2 Millimeters of mercury
Standard Deviation 4.59
|
-5.7 Millimeters of mercury
Standard Deviation 4.03
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
DBP,Day 2, Pre-dose
|
-1.5 Millimeters of mercury
Standard Deviation 4.55
|
2.0 Millimeters of mercury
Standard Deviation 7.47
|
-2.7 Millimeters of mercury
Standard Deviation 6.56
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
DBP,Day 3, Pre-dose
|
2.6 Millimeters of mercury
Standard Deviation 8.57
|
1.3 Millimeters of mercury
Standard Deviation 6.65
|
1.3 Millimeters of mercury
Standard Deviation 4.50
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
DBP,Day 3, 2 hours
|
3.1 Millimeters of mercury
Standard Deviation 7.00
|
4.0 Millimeters of mercury
Standard Deviation 5.31
|
-5.8 Millimeters of mercury
Standard Deviation 3.87
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
DBP,Day 3, 12 hours
|
-1.4 Millimeters of mercury
Standard Deviation 7.78
|
-1.4 Millimeters of mercury
Standard Deviation 5.72
|
-2.5 Millimeters of mercury
Standard Deviation 2.81
|
—
|
—
|
—
|
|
Change From Baseline in Blood Pressure: Part B
DBP,Day 4, 24 hours
|
3.0 Millimeters of mercury
Standard Deviation 5.56
|
4.6 Millimeters of mercury
Standard Deviation 4.77
|
1.3 Millimeters of mercury
Standard Deviation 6.65
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hoursPopulation: Safety Population
Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate: Part B
Day 1, 2 hours
|
0.0 Beats per minute
Standard Deviation 5.50
|
-2.4 Beats per minute
Standard Deviation 5.38
|
7.3 Beats per minute
Standard Deviation 6.89
|
—
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part B
Day 1, 12 hours
|
10.0 Beats per minute
Standard Deviation 4.00
|
8.8 Beats per minute
Standard Deviation 5.22
|
10.5 Beats per minute
Standard Deviation 3.78
|
—
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part B
Day 2, Pre-dose
|
-0.1 Beats per minute
Standard Deviation 4.68
|
-0.8 Beats per minute
Standard Deviation 6.37
|
-1.8 Beats per minute
Standard Deviation 2.71
|
—
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part B
Day 3, Pre-dose
|
2.3 Beats per minute
Standard Deviation 4.74
|
-0.1 Beats per minute
Standard Deviation 5.88
|
1.5 Beats per minute
Standard Deviation 5.43
|
—
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part B
Day 3, 2 hours
|
1.2 Beats per minute
Standard Deviation 5.37
|
-0.3 Beats per minute
Standard Deviation 5.36
|
4.0 Beats per minute
Standard Deviation 2.28
|
—
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part B
Day 3, 12 hours
|
8.6 Beats per minute
Standard Deviation 4.58
|
10.6 Beats per minute
Standard Deviation 7.26
|
7.7 Beats per minute
Standard Deviation 5.28
|
—
|
—
|
—
|
|
Change From Baseline in Heart Rate: Part B
Day 4, 24 hours
|
4.7 Beats per minute
Standard Deviation 8.64
|
6.7 Beats per minute
Standard Deviation 10.01
|
0.3 Beats per minute
Standard Deviation 2.58
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4 24 hoursPopulation: Safety Population
Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Respiration Rate: Part B
Day 1, 2 hours
|
0.5 Breaths per minute
Standard Deviation 2.27
|
-2.0 Breaths per minute
Standard Deviation 2.00
|
-1.2 Breaths per minute
Standard Deviation 3.54
|
—
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part B
Day 1, 12 hours
|
-0.1 Breaths per minute
Standard Deviation 1.37
|
-2.5 Breaths per minute
Standard Deviation 2.17
|
-1.5 Breaths per minute
Standard Deviation 2.35
|
—
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part B
Day 2, Pre-dose
|
-0.3 Breaths per minute
Standard Deviation 1.49
|
-0.5 Breaths per minute
Standard Deviation 2.07
|
-0.5 Breaths per minute
Standard Deviation 2.74
|
—
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part B
Day 3, Pre-dose
|
-0.7 Breaths per minute
Standard Deviation 2.67
|
-0.5 Breaths per minute
Standard Deviation 1.43
|
1.5 Breaths per minute
Standard Deviation 2.26
|
—
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part B
Day 3, 2 hours
|
-1.3 Breaths per minute
Standard Deviation 2.36
|
-1.0 Breaths per minute
Standard Deviation 2.21
|
-0.7 Breaths per minute
Standard Deviation 2.16
|
—
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part B
Day 3, 12 hours
|
0.3 Breaths per minute
Standard Deviation 3.02
|
-1.3 Breaths per minute
Standard Deviation 2.16
|
-0.8 Breaths per minute
Standard Deviation 1.33
|
—
|
—
|
—
|
|
Change From Baseline in Respiration Rate: Part B
Day 4, 24 hours
|
-0.8 Breaths per minute
Standard Deviation 1.87
|
-1.0 Breaths per minute
Standard Deviation 1.89
|
-0.3 Breaths per minute
Standard Deviation 2.42
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hoursPopulation: Safety Population
Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=10 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=10 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=6 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature: Part B
Day 1, 2 hours
|
0.03 Degree Celsius
Standard Deviation 0.298
|
-0.01 Degree Celsius
Standard Deviation 0.233
|
0.00 Degree Celsius
Standard Deviation 0.110
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part B
Day 1, 12 hours
|
0.06 Degree Celsius
Standard Deviation 0.181
|
0.08 Degree Celsius
Standard Deviation 0.274
|
0.07 Degree Celsius
Standard Deviation 0.082
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part B
Day 2, Pre-dose
|
0.04 Degree Celsius
Standard Deviation 0.184
|
-0.04 Degree Celsius
Standard Deviation 0.158
|
0.12 Degree Celsius
Standard Deviation 0.133
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part B
Day 3, Pre-dose
|
0.04 Degree Celsius
Standard Deviation 0.135
|
0.07 Degree Celsius
Standard Deviation 0.271
|
0.23 Degree Celsius
Standard Deviation 0.151
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part B
Day 3, 2 hours
|
-0.03 Degree Celsius
Standard Deviation 0.149
|
0.01 Degree Celsius
Standard Deviation 0.260
|
-0.08 Degree Celsius
Standard Deviation 0.147
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part B
Day 3, 12 hours
|
0.01 Degree Celsius
Standard Deviation 0.191
|
0.05 Degree Celsius
Standard Deviation 0.242
|
0.05 Degree Celsius
Standard Deviation 0.138
|
—
|
—
|
—
|
|
Change From Baseline in Body Temperature: Part B
Day 4, 24 hours
|
0.04 Degree Celsius
Standard Deviation 0.171
|
0.11 Degree Celsius
Standard Deviation 0.247
|
0.00 Degree Celsius
Standard Deviation 0.089
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population
SBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Blood Pressure: Part C
SBP, Day 1, 2 hours
|
-3.3 Millimeters of mercury
Standard Deviation 7.93
|
-0.6 Millimeters of mercury
Standard Deviation 7.50
|
-0.6 Millimeters of mercury
Standard Deviation 6.16
|
-4.9 Millimeters of mercury
Standard Deviation 9.18
|
1.1 Millimeters of mercury
Standard Deviation 16.02
|
-0.2 Millimeters of mercury
Standard Deviation 11.44
|
|
Change From Baseline in Blood Pressure: Part C
SBP,Day1, 12 hours
|
-3.1 Millimeters of mercury
Standard Deviation 10.04
|
-2.6 Millimeters of mercury
Standard Deviation 8.34
|
1.4 Millimeters of mercury
Standard Deviation 12.06
|
0.1 Millimeters of mercury
Standard Deviation 10.81
|
-7.3 Millimeters of mercury
Standard Deviation 14.92
|
0.9 Millimeters of mercury
Standard Deviation 16.03
|
|
Change From Baseline in Blood Pressure: Part C
SBP,Day2, 24 hours
|
4.9 Millimeters of mercury
Standard Deviation 8.02
|
-1.4 Millimeters of mercury
Standard Deviation 6.71
|
-1.6 Millimeters of mercury
Standard Deviation 8.39
|
-3.1 Millimeters of mercury
Standard Deviation 8.50
|
2.6 Millimeters of mercury
Standard Deviation 10.84
|
-7.5 Millimeters of mercury
Standard Deviation 10.58
|
|
Change From Baseline in Blood Pressure: Part C
DBP, Day 1, 2 hours
|
-0.1 Millimeters of mercury
Standard Deviation 7.41
|
-0.7 Millimeters of mercury
Standard Deviation 6.43
|
2.0 Millimeters of mercury
Standard Deviation 6.92
|
-4.3 Millimeters of mercury
Standard Deviation 6.94
|
-0.6 Millimeters of mercury
Standard Deviation 7.88
|
-1.9 Millimeters of mercury
Standard Deviation 5.50
|
|
Change From Baseline in Blood Pressure: Part C
DBP,Day1, 12 hours
|
-2.1 Millimeters of mercury
Standard Deviation 7.23
|
-1.1 Millimeters of mercury
Standard Deviation 6.36
|
-3.1 Millimeters of mercury
Standard Deviation 6.53
|
-0.6 Millimeters of mercury
Standard Deviation 8.02
|
-3.7 Millimeters of mercury
Standard Deviation 9.61
|
0.0 Millimeters of mercury
Standard Deviation 8.38
|
|
Change From Baseline in Blood Pressure: Part C
DBP,Day2, 24 hours
|
0.4 Millimeters of mercury
Standard Deviation 7.21
|
1.0 Millimeters of mercury
Standard Deviation 4.88
|
-0.5 Millimeters of mercury
Standard Deviation 6.64
|
2.8 Millimeters of mercury
Standard Deviation 6.37
|
0.7 Millimeters of mercury
Standard Deviation 7.49
|
2.4 Millimeters of mercury
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population
Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate: Part C
Day 1, 2 hours
|
2.1 Beats per minute
Standard Deviation 6.94
|
-5.3 Beats per minute
Standard Deviation 6.19
|
0.0 Beats per minute
Standard Deviation 6.86
|
7.3 Beats per minute
Standard Deviation 6.56
|
8.2 Beats per minute
Standard Deviation 5.72
|
8.2 Beats per minute
Standard Deviation 7.32
|
|
Change From Baseline in Heart Rate: Part C
Day 1, 12 hours
|
6.8 Beats per minute
Standard Deviation 6.20
|
6.5 Beats per minute
Standard Deviation 9.73
|
11.2 Beats per minute
Standard Deviation 9.65
|
10.3 Beats per minute
Standard Deviation 6.94
|
9.3 Beats per minute
Standard Deviation 8.28
|
8.6 Beats per minute
Standard Deviation 6.99
|
|
Change From Baseline in Heart Rate: Part C
Day 2, 24 hours
|
1.8 Beats per minute
Standard Deviation 5.44
|
0.1 Beats per minute
Standard Deviation 6.41
|
-0.4 Beats per minute
Standard Deviation 3.77
|
0.4 Beats per minute
Standard Deviation 5.80
|
-0.9 Beats per minute
Standard Deviation 6.19
|
1.6 Beats per minute
Standard Deviation 7.74
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population
Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Respiration Rate: Part C
Day 1, 2 hours
|
1.7 Breaths per minute
Standard Deviation 3.37
|
0.6 Breaths per minute
Standard Deviation 2.03
|
0.9 Breaths per minute
Standard Deviation 2.90
|
-1.1 Breaths per minute
Standard Deviation 2.95
|
1.8 Breaths per minute
Standard Deviation 1.74
|
0.1 Breaths per minute
Standard Deviation 2.76
|
|
Change From Baseline in Respiration Rate: Part C
Day 1, 12 hours
|
1.1 Breaths per minute
Standard Deviation 2.59
|
1.0 Breaths per minute
Standard Deviation 2.85
|
0.6 Breaths per minute
Standard Deviation 2.66
|
-1.1 Breaths per minute
Standard Deviation 2.90
|
-0.3 Breaths per minute
Standard Deviation 2.61
|
0.5 Breaths per minute
Standard Deviation 1.51
|
|
Change From Baseline in Respiration Rate: Part C
Day 2, 24 hours
|
1.6 Breaths per minute
Standard Deviation 3.25
|
0.4 Breaths per minute
Standard Deviation 3.07
|
0.6 Breaths per minute
Standard Deviation 4.00
|
-2.2 Breaths per minute
Standard Deviation 2.66
|
1.8 Breaths per minute
Standard Deviation 2.31
|
0.4 Breaths per minute
Standard Deviation 3.34
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hoursPopulation: Safety Population
Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
Part A: IR 120mg Fasted
n=15 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A: MT-8hour 120mg Fasted
n=15 Participants
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A: MT-12hour 120mg Fed (High Fat)
n=16 Participants
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part A: IR 120mg Fasted
n=16 Participants
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part C:MM-12h 480mg Delayed Fed(Standard)
n=15 Participants
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C: MM-12h 240mg Delayed Fed(High Fat)
n=14 Participants
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Temperature: Part C
Day 1, 2 hours
|
-0.10 Degree Celsius
Standard Deviation 0.245
|
-0.05 Degree Celsius
Standard Deviation 0.192
|
-0.07 Degree Celsius
Standard Deviation 0.215
|
0.23 Degree Celsius
Standard Deviation 0.275
|
0.01 Degree Celsius
Standard Deviation 0.228
|
0.10 Degree Celsius
Standard Deviation 0.301
|
|
Change From Baseline in Body Temperature: Part C
Day 1, 12 hours
|
0.02 Degree Celsius
Standard Deviation 0.197
|
-0.11 Degree Celsius
Standard Deviation 0.229
|
-0.05 Degree Celsius
Standard Deviation 0.271
|
0.12 Degree Celsius
Standard Deviation 0.307
|
-0.14 Degree Celsius
Standard Deviation 0.241
|
-0.10 Degree Celsius
Standard Deviation 0.266
|
|
Change From Baseline in Body Temperature: Part C
Day 2, 24 hours
|
-0.04 Degree Celsius
Standard Deviation 0.256
|
0.15 Degree Celsius
Standard Deviation 0.261
|
-0.00 Degree Celsius
Standard Deviation 0.239
|
0.10 Degree Celsius
Standard Deviation 0.278
|
-0.09 Degree Celsius
Standard Deviation 0.269
|
-0.01 Degree Celsius
Standard Deviation 0.241
|
Adverse Events
Part A:IR 120mg Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A:MT-12hour 120mg Fasted
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Part A:MT-8hour 120mg Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A:MT-12hour 120mg Fed (High Fat)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B:MT-12hour 120mg Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B:MT-12hour 240mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B:MT-12hour 300mg Fed (Standard)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part C:IR 240mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part C:MM-12hour 240mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part C:MM-12hour 480mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part C:MM-12hour 480mg Fed (Standard)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part C:MM-12hour 480mg Delayed Fed (Standard)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C:MM-12hour 240mg Delayed Fed (High Fat)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A:IR 120mg Fasted
n=16 participants at risk
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A:MT-12hour 120mg Fasted
n=16 participants at risk
Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state
|
Part A:MT-8hour 120mg Fasted
n=13 participants at risk
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A:MT-12hour 120mg Fed (High Fat)
n=16 participants at risk
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part B:MT-12hour 120mg Fasted
n=10 participants at risk
Participants received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days.
|
Part B:MT-12hour 240mg Fasted
n=10 participants at risk
Participants received once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days
|
Part B:MT-12hour 300mg Fed (Standard)
n=6 participants at risk
Participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days
|
Part C:IR 240mg Fasted
n=15 participants at risk
Participants received a single dose of 240 mg GSK2982772 IR tablet in fasted state
|
Part C:MM-12hour 240mg Fasted
n=15 participants at risk
Participants received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted state
|
Part C:MM-12hour 480mg Fasted
n=16 participants at risk
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state
|
Part C:MM-12hour 480mg Fed (Standard)
n=16 participants at risk
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state
|
Part C:MM-12hour 480mg Delayed Fed (Standard)
n=15 participants at risk
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C:MM-12hour 240mg Delayed Fed (High Fat)
n=14 participants at risk
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
Other adverse events
| Measure |
Part A:IR 120mg Fasted
n=16 participants at risk
Participants received a single oral dose of 120 mg GSK2982772 (4x30 mg) IR tablet in fasted state
|
Part A:MT-12hour 120mg Fasted
n=16 participants at risk
Participants received a single dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state
|
Part A:MT-8hour 120mg Fasted
n=13 participants at risk
Participants received single dose of 120 mg GSK2982772 MR MT-8hour capsule (80% release at 8 hours) in fasted state
|
Part A:MT-12hour 120mg Fed (High Fat)
n=16 participants at risk
Participants received single oral dose of 120 mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) after high fat meal
|
Part B:MT-12hour 120mg Fasted
n=10 participants at risk
Participants received once daily dose of 120mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days.
|
Part B:MT-12hour 240mg Fasted
n=10 participants at risk
Participants received once daily dose of 240mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fasted state for 3 days
|
Part B:MT-12hour 300mg Fed (Standard)
n=6 participants at risk
Participants received once daily dose of 300mg GSK2982772 MR MT-12hour capsule (80% release at 12 hours) in fed state (standard meal) for 3 days
|
Part C:IR 240mg Fasted
n=15 participants at risk
Participants received a single dose of 240 mg GSK2982772 IR tablet in fasted state
|
Part C:MM-12hour 240mg Fasted
n=15 participants at risk
Participants received a single dose of 240 mg GSK2982772 MR MM-12hour tablet (80% release at 12 hours) in fasted state
|
Part C:MM-12hour 480mg Fasted
n=16 participants at risk
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fasted state
|
Part C:MM-12hour 480mg Fed (Standard)
n=16 participants at risk
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state
|
Part C:MM-12hour 480mg Delayed Fed (Standard)
n=15 participants at risk
Participants received a single dose of 480 mg GSK2982772 MR MM-12 hour tablet (80% release at 12 hours) in fed state. Participants had received a dose before standard breakfast (delayed fed).
|
Part C:MM-12hour 240mg Delayed Fed (High Fat)
n=14 participants at risk
Participants received a single dose of 240 mg GSK2982772 MR MM-12hours (80% release at 12 hours). Participants had received a dose before high-fat breakfast (delayed fed).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.5%
2/16 • Number of events 2 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
12.5%
2/16 • Number of events 2 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Catheter site bruise
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
12.5%
2/16 • Number of events 2 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
13.3%
2/15 • Number of events 2 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
12.5%
2/16 • Number of events 2 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
12.5%
2/16 • Number of events 3 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
7.1%
1/14 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Eye disorders
Eye haematoma
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
7.7%
1/13 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Injury associated with device
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
16.7%
1/6 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Catheter site pain
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Catheter site swelling
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
10.0%
1/10 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/13 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/10 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/6 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
6.7%
1/15 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/15 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/14 • Non-serious AEs and SAEs were collected up to Day 43 for Part A and Part C and up to Day 22 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
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