Trial Outcomes & Findings for A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772 (NCT NCT03649412)
NCT ID: NCT03649412
Last Updated: 2020-05-01
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were analyzed using standard non-compartmental analysis. Participants in the 'Safety Population (all participants who received at least one dose of study treatment)' for whom a PK sample was obtained and analyzed were part of PK Population.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Results posted on
2020-05-01
Participant Flow
This was an open-label, 2-part (Part A \& B), single dose study in healthy participants to assess modified release (MR) prototype coated tablet formulations of GSK2982772 compared to an immediate release reference tablet formulation.
A total of 33 participants were enrolled in this study. In Part A, 16 participants were enrolled but 1 replacement participant was added (total=17). Participants from Part A did not continue to Part B. In Part B, 16 participants were enrolled.
Participant milestones
| Measure |
MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast
Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent \[%\] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water.
|
MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std)
Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water.
|
|---|---|---|
|
Part A, Period 1 (4 Days)
STARTED
|
16
|
0
|
|
Part A, Period 1 (4 Days)
COMPLETED
|
16
|
0
|
|
Part A, Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part A, Washout Period 1 (7 Days)
STARTED
|
16
|
0
|
|
Part A, Washout Period 1 (7 Days)
COMPLETED
|
15
|
0
|
|
Part A, Washout Period 1 (7 Days)
NOT COMPLETED
|
1
|
0
|
|
Part A, Period 2 (3 Days)
STARTED
|
16
|
0
|
|
Part A, Period 2 (3 Days)
COMPLETED
|
16
|
0
|
|
Part A, Period 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
|
Part A, Washout Period 2 (7 Days)
STARTED
|
16
|
0
|
|
Part A, Washout Period 2 (7 Days)
COMPLETED
|
16
|
0
|
|
Part A, Washout Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Part A, Period 3 (4 Days)
STARTED
|
16
|
0
|
|
Part A, Period 3 (4 Days)
COMPLETED
|
16
|
0
|
|
Part A, Period 3 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part A, Washout Period 3 (7 Days)
STARTED
|
16
|
0
|
|
Part A, Washout Period 3 (7 Days)
COMPLETED
|
16
|
0
|
|
Part A, Washout Period 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Part A, Period 4 (4 Days)
STARTED
|
16
|
0
|
|
Part A, Period 4 (4 Days)
COMPLETED
|
16
|
0
|
|
Part A, Period 4 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part A, Washout Period 4 (7 Days)
STARTED
|
16
|
0
|
|
Part A, Washout Period 4 (7 Days)
COMPLETED
|
14
|
0
|
|
Part A, Washout Period 4 (7 Days)
NOT COMPLETED
|
2
|
0
|
|
Part A, Period 5 (4 Days)
STARTED
|
12
|
0
|
|
Part A, Period 5 (4 Days)
COMPLETED
|
12
|
0
|
|
Part A, Period 5 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part A, Washout Period 5 (7 Days)
STARTED
|
12
|
0
|
|
Part A, Washout Period 5 (7 Days)
COMPLETED
|
11
|
0
|
|
Part A, Washout Period 5 (7 Days)
NOT COMPLETED
|
1
|
0
|
|
Part A, Period 6 (4 Days)
STARTED
|
12
|
0
|
|
Part A, Period 6 (4 Days)
COMPLETED
|
12
|
0
|
|
Part A, Period 6 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Period 1 (4 Days)
STARTED
|
0
|
16
|
|
Part B, Period 1 (4 Days)
COMPLETED
|
0
|
16
|
|
Part B, Period 1 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Washout Period 1 (7 Days)
STARTED
|
0
|
16
|
|
Part B, Washout Period 1 (7 Days)
COMPLETED
|
0
|
15
|
|
Part B, Washout Period 1 (7 Days)
NOT COMPLETED
|
0
|
1
|
|
Part B, Period 2 (4 Days)
STARTED
|
0
|
15
|
|
Part B, Period 2 (4 Days)
COMPLETED
|
0
|
15
|
|
Part B, Period 2 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Washout Period 2 (7 Days)
STARTED
|
0
|
15
|
|
Part B, Washout Period 2 (7 Days)
COMPLETED
|
0
|
15
|
|
Part B, Washout Period 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Period 3 (4 Days)
STARTED
|
0
|
15
|
|
Part B, Period 3 (4 Days)
COMPLETED
|
0
|
15
|
|
Part B, Period 3 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Washout Period 3 (7 Days)
STARTED
|
0
|
15
|
|
Part B, Washout Period 3 (7 Days)
COMPLETED
|
0
|
15
|
|
Part B, Washout Period 3 (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Period 4 (4 Days)
STARTED
|
0
|
15
|
|
Part B, Period 4 (4 Days)
COMPLETED
|
0
|
15
|
|
Part B, Period 4 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Washout Period 4 (7 Days)
STARTED
|
0
|
15
|
|
Part B, Washout Period 4 (7 Days)
COMPLETED
|
0
|
15
|
|
Part B, Washout Period 4 (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Period 5 (4 Days)
STARTED
|
0
|
14
|
|
Part B, Period 5 (4 Days)
COMPLETED
|
0
|
14
|
|
Part B, Period 5 (4 Days)
NOT COMPLETED
|
0
|
0
|
|
Part B, Washout Period 5 (7 Days)
STARTED
|
0
|
14
|
|
Part B, Washout Period 5 (7 Days)
COMPLETED
|
0
|
13
|
|
Part B, Washout Period 5 (7 Days)
NOT COMPLETED
|
0
|
1
|
|
Part B, Period 6 (4days)
STARTED
|
0
|
14
|
|
Part B, Period 6 (4days)
COMPLETED
|
0
|
14
|
|
Part B, Period 6 (4days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast
Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent \[%\] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water.
|
MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std)
Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water.
|
|---|---|---|
|
Part A, Washout Period 1 (7 Days)
Physician Decision
|
1
|
0
|
|
Part A, Washout Period 4 (7 Days)
Adverse Event
|
1
|
0
|
|
Part A, Washout Period 4 (7 Days)
Withdrawal by Subject
|
1
|
0
|
|
Part A, Washout Period 5 (7 Days)
Adverse Event
|
1
|
0
|
|
Part B, Washout Period 1 (7 Days)
Adverse Event
|
0
|
1
|
|
Part B, Washout Period 5 (7 Days)
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772
Baseline characteristics by cohort
| Measure |
MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast
n=17 Participants
Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent \[%\] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water.
|
MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std)
n=16 Participants
Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 Years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
54.0 Years
STANDARD_DEVIATION 6.30 • n=7 Participants
|
48.6 Years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ARABIC/NORTH AFRICAN HERITAGE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
AFRICAN AMERICAN/AFRICAN HERITAGE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
CENTRAL/SOUTH ASIAN HERITAGE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were analyzed using standard non-compartmental analysis. Participants in the 'Safety Population (all participants who received at least one dose of study treatment)' for whom a PK sample was obtained and analyzed were part of PK Population.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 240 mg in IR Formulation
|
14.355 Hours*microgram per milliliter
Geometric Coefficient of Variation 31.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=13 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=7 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation
|
7.757 Hours*microgram per milliliter
Geometric Coefficient of Variation 19.1
|
8.346 Hours*microgram per milliliter
Geometric Coefficient of Variation 27.7
|
7.080 Hours*microgram per milliliter
Geometric Coefficient of Variation 46.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=7 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation After High-fat Breakfast
|
9.372 Hours*microgram per milliliter
Geometric Coefficient of Variation 21.8
|
8.220 Hours*microgram per milliliter
Geometric Coefficient of Variation 37.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 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). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 240 mg for IR Formulation
|
14.269 Hours*microgram per milliliter
Geometric Coefficient of Variation 31.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation
|
8.175 Hours*microgram per milliliter
Geometric Coefficient of Variation 23.9
|
7.828 Hours*microgram per milliliter
Geometric Coefficient of Variation 28.5
|
7.365 Hours*microgram per milliliter
Geometric Coefficient of Variation 36.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
|
9.359 Hours*microgram per milliliter
Geometric Coefficient of Variation 23.1
|
8.384 Hours*microgram per milliliter
Geometric Coefficient of Variation 32.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 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). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 240 mg for IR Formulation
|
14.268 Hours*microgram per milliliter
Geometric Coefficient of Variation 31.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation
|
6.670 Hours*microgram per milliliter
Geometric Coefficient of Variation 24.9
|
5.784 Hours*microgram per milliliter
Geometric Coefficient of Variation 31.8
|
5.466 Hours*microgram per milliliter
Geometric Coefficient of Variation 33.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
|
7.136 Hours*microgram per milliliter
Geometric Coefficient of Variation 33.5
|
5.821 Hours*microgram per milliliter
Geometric Coefficient of Variation 32.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 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. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Concentration (Cmax) of GSK2982772 240 mg for IR Formulation
|
3.177 Microgram per milliliter
Geometric Coefficient of Variation 40.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation
|
0.682 Microgram per milliliter
Geometric Coefficient of Variation 39.4
|
0.527 Microgram per milliliter
Geometric Coefficient of Variation 24.4
|
0.466 Microgram per milliliter
Geometric Coefficient of Variation 27.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
|
0.824 Microgram per milliliter
Geometric Coefficient of Variation 47.5
|
0.678 Microgram per milliliter
Geometric Coefficient of Variation 47.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Concentration at 24 Hours Post-dose (C24h) of GSK2982772 240 mg for IR Formulation
|
0.015 Microgram per milliliter
Geometric Coefficient of Variation 60.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation
|
0.196 Microgram per milliliter
Geometric Coefficient of Variation 64.8
|
0.211 Microgram per milliliter
Geometric Coefficient of Variation 63.1
|
0.165 Microgram per milliliter
Geometric Coefficient of Variation 98.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
|
0.213 Microgram per milliliter
Geometric Coefficient of Variation 70.4
|
0.265 Microgram per milliliter
Geometric Coefficient of Variation 85.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Time to Cmax (Tmax) of GSK2982772 240 mg for IR Formulation
|
2.000 Hours
Interval 1.0 to 5.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation
|
5.000 Hours
Interval 4.0 to 12.03
|
10.000 Hours
Interval 4.0 to 24.2
|
6.000 Hours
Interval 4.0 to 16.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
|
8.000 Hours
Interval 2.0 to 22.0
|
11.000 Hours
Interval 8.0 to 22.32
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Terminal Half-life (t1/2) of GSK2982772 240 mg for IR Formulation
|
3.288 Hours
Standard Deviation 0.5010
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hoursPopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation
|
6.329 Hours
Standard Deviation 2.1447
|
6.953 Hours
Standard Deviation 2.4983
|
7.532 Hours
Standard Deviation 2.2685
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hoursPopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
|
7.763 Hours
Standard Deviation 1.4693
|
6.589 Hours
Standard Deviation 1.0499
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at specified time points were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-inf). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=11 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=8 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
|
20.121 Hours*microgram per milliliter
Geometric Coefficient of Variation 46.2
|
20.178 Hours*microgram per milliliter
Geometric Coefficient of Variation 62.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for AUC(0-t). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=15 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=14 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
|
19.865 Hours*microgram per milliliter
Geometric Coefficient of Variation 39.7
|
17.861 Hours*microgram per milliliter
Geometric Coefficient of Variation 47.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=15 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=14 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: Cmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
|
1.896 Hours*microgram per milliliter
Geometric Coefficient of Variation 63.3
|
1.791 Hours*microgram per milliliter
Geometric Coefficient of Variation 75.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=15 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=14 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: C24h of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
|
0.622 Microgram per milliliter
Geometric Coefficient of Variation 132.9
|
1.176 Microgram per milliliter
Geometric Coefficient of Variation 80.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=15 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=14 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: Tmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
|
12.000 Hours
Interval 6.0 to 28.0
|
22.008 Hours
Interval 10.0 to 24.05
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population. Only those participants with data available at specified time point were analyzed.
Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=11 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=8 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: t1/2 of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
|
4.961 Hours
Standard Deviation 1.0921
|
4.873 Hours
Standard Deviation 1.9915
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 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 FrelFE based on AUC of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=13 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Relative Bioavailability in Fed Versus Fasted Conditions (FrelFE) Based on AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation
|
102.66 Percentage bioavailability
Interval 88.84 to 118.63
|
113.66 Percentage bioavailability
Interval 95.53 to 135.24
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772. Frel for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR Fed/Geometric mean of AUC(0-t) of MR Fasted multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: FrelFE Based on AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation
|
107.11 Percentage bioavailability
Interval 95.72 to 119.85
|
107.81 Percentage bioavailability
Interval 95.16 to 122.14
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fed/Geometric mean of Cmax of MR Fasted multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: FrelFE Based on Cmax of GSK2982772 for MR Coated Tablet Formulation
|
128.79 Percentage bioavailability
Interval 108.64 to 152.67
|
112.15 Percentage bioavailability
Interval 92.9 to 135.38
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 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 FrelFE based on AUC(0-inf) of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=11 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: FrelFE of GSK2982772 Based on AUC(0-inf) for MR Coated Tablet Formulation in Fed vs Fasted State
|
141.75 Percentage bioavailability
Interval 113.47 to 177.07
|
97.13 Percentage bioavailability
Interval 78.47 to 120.22
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of FrelFE based on AUC (0-t) of GSK2982772. FrelFE for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MR Fed/ Geometric mean of AUC (0-t) of MR Fasted multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: FrelFE of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fed vs Fasted State
|
129.63 Percentage bioavailability
Interval 109.23 to 153.83
|
89.77 Percentage bioavailability
Interval 75.37 to 106.92
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. FrelFE for Cmax was calculated as Geometric mean of Cmax of MR Fed/ Geometric mean of Cmax of MR Fasted multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: FrelFE of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fed vs Fasted State
|
173.19 Percentage bioavailability
Interval 138.68 to 216.28
|
102.39 Percentage bioavailability
Interval 81.61 to 128.47
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 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 Frel (dose) based on AUC (0-inf) of GSK2982772. Frel (dose) for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MR formulation (test dose) Fasted/ Geometric mean of AUC (0-inf) of MR Fasted formulation (reference dose) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=10 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=14 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=14 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State
|
214.21 Percentage bioavailability
Interval 171.24 to 267.95
|
530.86 Percentage bioavailability
Interval 431.89 to 652.49
|
247.82 Percentage bioavailability
Interval 201.7 to 304.49
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC(0-t) of GSK2982772. Frel (dose) for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR formulation (test dose) Fasted/ Geometric mean of AUC(0-t) of MR Fasted formulation (reference dose) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=15 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State
|
192.81 Percentage bioavailability
Interval 162.47 to 228.8
|
539.66 Percentage bioavailability
Interval 454.37 to 640.96
|
279.90 Percentage bioavailability
Interval 235.86 to 332.16
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 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 Frel (dose) based on AUC(0-24) of GSK2982772. Frel (dose) for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR formulation (test dose) Fasted/Geometric mean of AUC(0-24) of MR Fasted formulation (reference dose) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=15 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State
|
175.58 Percentage bioavailability
Interval 143.34 to 215.08
|
392.65 Percentage bioavailability
Interval 320.16 to 481.54
|
223.63 Percentage bioavailability
Interval 182.56 to 273.93
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Frel dose. Frel for Cmax was calculated as Geometric mean of Cmax of MR formulation (test) Fasted/ Geometric mean of Cmax of MR Fasted Formulation (reference dose) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=15 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State
|
160.00 Percentage bioavailability
Interval 128.12 to 199.81
|
338.70 Percentage bioavailability
Interval 270.88 to 423.89
|
211.68 Percentage bioavailability
Interval 169.51 to 264.35
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC(0-inf) of GSK2982772 in fasted state. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR formulation (test) Fasted/ Geometric mean of AUC(0-inf) of Fasted of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg
|
54.68 Percentage bioavailability
Interval 47.64 to 62.76
|
48.32 Percentage bioavailability
Interval 40.96 to 57.01
|
57.69 Percentage bioavailability
Interval 50.58 to 65.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hoursPopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC (0-t) was calculated as Geometric mean of AUC(0-t) of MR Fasted formulation (test) / Geometric mean of AUC(0-t) of Fasted of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)
|
57.72 Percentage bioavailability
Interval 51.51 to 64.69
|
49.61 Percentage bioavailability
Interval 43.86 to 56.11
|
54.86 Percentage bioavailability
Interval 49.03 to 61.39
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hoursPopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR Fasted formulation (test) / Geometric mean of AUC(0-24) of Fasted of IR Formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)
|
47.77 Percentage bioavailability
Interval 41.92 to 54.43
|
36.85 Percentage bioavailability
Interval 31.99 to 42.45
|
40.54 Percentage bioavailability
Interval 35.63 to 46.13
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hoursPopulation: PK Population.
Blood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 in fasted state. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fasted formulation (test) / Geometric mean of Cmax of Fasted Formulation of IR formulation (reference) multiplied by 100.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)
|
22.29 Percentage bioavailability
Interval 18.77 to 26.47
|
14.16 Percentage bioavailability
Interval 11.75 to 17.06
|
16.58 Percentage bioavailability
Interval 13.99 to 19.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 67Population: Safety Population consisted of all participants who receive at least 1 dose of study treatment.
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 that 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
2 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 67Population: Safety Population.
Clinical chemistry parameters with PCI values:albumin (low: \<30 millimoles per liter\[mmol/L\]), Alanine transaminase (ALT) (high: \>=2xupper limit of normal \[ULN\]), Aspartate Aminotransferase(AST) (high: \>=2xULN), Alkaline phosphatase(ALP) (high:\>=2xULN), calcium(low: \<2 mmol/L, high: \>2.75 mmol/L),creatinine (high: \>44.2 mmol/L),glucose (low: \<3 mmol/L,high: \>9 mmol/L), potassium (low: \<3 mmol/L,high: \>5.5 mmol/L),sodium (low: \<130 mmol/L,high: \>150 mmol/L),total bilirubin(high :\>= 1.5xULN). 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 participants has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Albumin, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Creatinine, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
ALT, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
ALT, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
AST, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
AST, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
ALP, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
ALP, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Albumin, To Normal or no Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Calcium, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Calcium, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
14 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Calcium, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Creatinine, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Glucose, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Glucose, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Glucose, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Potassium, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Potassium, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Potassium, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Sodium, To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Sodium, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Sodium, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Total Bilirubin, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Total Bilirubin, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 67Population: Safety Population.
Hematology parameters with PCI ranges: hematocrit (high: \>0.54 percentage of red blood cells), hemoglobin (high: \>180 grams per liter \[g/L\]), lymphocytes (low: \<0.8\*giga cells per liter \[10\^9/L\]), total neutrophil count (low: \<1.5\*10\^9/L), platelet count (low: \<100\*10\^9/L and high: \>550\*10\^9/L), and while blood cell (WBC) count (low: \<3\*10\^9/L and high: \>20\*10\^9/L). 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%. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Lymphocytes, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Platelet count, To Normal or No change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Platelet count, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Platelet count, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Hemotocrit, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Hematocrit, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Hemoglobin, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Hemoglobin, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Lymphocytes, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Total neutrophils, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Total Neutrophils, To Normal or No Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
WBC count, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
WBC count, To Normal or no Change
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
16 Participants
|
12 Participants
|
|
Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
WBC count, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2 (post-dose)Population: 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 was performed abnormal data for red blood cells (RBC): 1-9 High potential field (HPF) and WBC: 1-9/ HPF; WBC: 10-50/HPF has been presented.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Urinalysis Dipstick Results
RBC 1-9/ HPF
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Abnormal Urinalysis Dipstick Results
WBC 1-9/HPF
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Part A: Number of Participants With Abnormal Urinalysis Dipstick Results
WBC 10-50/HPF
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hoursPopulation: Safety Population.
SBP and DBP were measured in a semi-supine position after 5 minutes of rest of the participant. 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation
SBP, Day 1, 2 hours
|
-3.9 Millimeters of mercury
Standard Deviation 6.29
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation
SBP, Day 1, 12 hours
|
-3.3 Millimeters of mercury
Standard Deviation 6.39
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation
SBP, Day 2, 24 hours
|
-6.6 Millimeters of mercury
Standard Deviation 7.26
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation
DBP, Day1, 2 hours
|
-1.1 Millimeters of mercury
Standard Deviation 3.00
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation
DBP, Day 1, 12 hours
|
-5.1 Millimeters of mercury
Standard Deviation 3.51
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation
DBP, Day 2, 24 hours
|
-1.4 Millimeters of mercury
Standard Deviation 4.63
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hoursPopulation: Safety Population.
SBP and DBP were measured in a semi-supine position after 5 minutes of rest of the participant. 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
SBP, Day1, 2 hours
|
-2.7 Millimeters of mercury
Standard Deviation 5.76
|
-7.9 Millimeters of mercury
Standard Deviation 6.82
|
-7.3 Millimeters of mercury
Standard Deviation 8.57
|
-4.6 Millimeters of mercury
Standard Deviation 8.38
|
-3.4 Millimeters of mercury
Standard Deviation 9.18
|
—
|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
SBP, Day1, 12 hours
|
-3.0 Millimeters of mercury
Standard Deviation 8.07
|
-6.9 Millimeters of mercury
Standard Deviation 8.32
|
-2.4 Millimeters of mercury
Standard Deviation 10.07
|
-0.09 Millimeters of mercury
Standard Deviation 13.02
|
-1.3 Millimeters of mercury
Standard Deviation 10.54
|
—
|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
SBP, Day 2, 24 hours
|
-3.9 Millimeters of mercury
Standard Deviation 7.55
|
-10.3 Millimeters of mercury
Standard Deviation 8.69
|
-2.8 Millimeters of mercury
Standard Deviation 8.87
|
-6.8 Millimeters of mercury
Standard Deviation 5.72
|
-2.3 Millimeters of mercury
Standard Deviation 7.01
|
—
|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
SBP, Day3, 48 hours,
|
-2.0 Millimeters of mercury
Standard Deviation 9.29
|
-5.3 Millimeters of mercury
Standard Deviation 7.15
|
-1.7 Millimeters of mercury
Standard Deviation 8.87
|
-4.2 Millimeters of mercury
Standard Deviation 7.74
|
2.8 Millimeters of mercury
Standard Deviation 7.88
|
—
|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
DBP, Day1, 2 hours
|
-4.5 Millimeters of mercury
Standard Deviation 5.67
|
-5.3 Millimeters of mercury
Standard Deviation 5.70
|
-6.1 Millimeters of mercury
Standard Deviation 3.53
|
-6.9 Millimeters of mercury
Standard Deviation 5.11
|
-2.3 Millimeters of mercury
Standard Deviation 8.64
|
—
|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
DBP, Day1, 12 hours
|
-7.6 Millimeters of mercury
Standard Deviation 7.46
|
-8.3 Millimeters of mercury
Standard Deviation 5.35
|
-5.7 Millimeters of mercury
Standard Deviation 5.14
|
-5.9 Millimeters of mercury
Standard Deviation 6.35
|
-5.3 Millimeters of mercury
Standard Deviation 7.12
|
—
|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
DBP, Day2, 24 hours
|
-2.4 Millimeters of mercury
Standard Deviation 6.30
|
-10.0 Millimeters of mercury
Standard Deviation 4.15
|
-6.6 Millimeters of mercury
Standard Deviation 5.76
|
-4.5 Millimeters of mercury
Standard Deviation 4.93
|
-0.4 Millimeters of mercury
Standard Deviation 6.82
|
—
|
|
Part A: Change From Baseline in SBP and DBP in MR Formulation
DBP, Day3, 48 hours
|
-3.7 Millimeters of mercury
Standard Deviation 6.26
|
-3.7 Millimeters of mercury
Standard Deviation 4.71
|
-2.1 Millimeters of mercury
Standard Deviation 7.33
|
-2.4 Millimeters of mercury
Standard Deviation 5.20
|
-1.1 Millimeters of mercury
Standard Deviation 7.74
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hoursPopulation: Safety Population.
Heart rate was measured in a semi-supine position after 5 minutes of rest of participant. 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Heart Rate in IR Formulation
Day 1, 2 hours
|
-2.6 Beats per minute
Standard Deviation 8.37
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Heart Rate in IR Formulation
Day 1, 12 hours
|
6.3 Beats per minute
Standard Deviation 11.51
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Heart Rate in IR Formulation
Day 2, 24 hours
|
-2.1 Beats per minute
Standard Deviation 7.73
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hoursPopulation: Safety Population.
Heart rate was measured in a semi-supine position after 5 minutes of rest of participant. 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Heart Rate in MR Formulation
Day 1, 2 hours
|
-1.3 Beats per minute
Standard Deviation 7.22
|
-6.1 Beats per minute
Standard Deviation 7.78
|
5.8 Beats per minute
Standard Deviation 6.87
|
3.1 Beats per minute
Standard Deviation 7.33
|
-1.3 Beats per minute
Standard Deviation 5.87
|
—
|
|
Part A: Change From Baseline in Heart Rate in MR Formulation
Day 1, 12 hours
|
5.4 Beats per minute
Standard Deviation 9.62
|
6.1 Beats per minute
Standard Deviation 9.79
|
9.8 Beats per minute
Standard Deviation 7.72
|
3.4 Beats per minute
Standard Deviation 10.19
|
8.8 Beats per minute
Standard Deviation 8.41
|
—
|
|
Part A: Change From Baseline in Heart Rate in MR Formulation
Day 2, 24 hours
|
0.7 Beats per minute
Standard Deviation 7.36
|
-4.7 Beats per minute
Standard Deviation 8.72
|
2.4 Beats per minute
Standard Deviation 8.56
|
1.6 Beats per minute
Standard Deviation 9.21
|
-2.4 Beats per minute
Standard Deviation 4.12
|
—
|
|
Part A: Change From Baseline in Heart Rate in MR Formulation
Day 3, 48 hours
|
8.6 Beats per minute
Standard Deviation 11.39
|
0.4 Beats per minute
Standard Deviation 8.58
|
3.8 Beats per minute
Standard Deviation 5.67
|
4.7 Beats per minute
Standard Deviation 9.71
|
7.3 Beats per minute
Standard Deviation 7.19
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hoursPopulation: Safety Population.
Respiratory rate was measured in a semi-supine position after 5 minutes of rest of the participant. 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Respiration Rate in IR Formulation
Day 1, 2 hours
|
-0.4 Breaths per minute
Standard Deviation 3.08
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Respiration Rate in IR Formulation
Day 1, 12 hours
|
-0.2 Breaths per minute
Standard Deviation 2.10
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Respiration Rate in IR Formulation
Day 2, 24 hours
|
-0.8 Breaths per minute
Standard Deviation 3.53
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hoursPopulation: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Respiratory rate was measured in a semi-supine position after 5 minutes of rest of the participant. 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Respiration Rate in MR Formulation
Day 1, 2 hours; n=16, 16, 12, 16, 12
|
0.9 Breaths per minute
Standard Deviation 2.89
|
2.5 Breaths per minute
Standard Deviation 2.58
|
2.8 Breaths per minute
Standard Deviation 2.29
|
2.0 Breaths per minute
Standard Deviation 2.13
|
0.0 Breaths per minute
Standard Deviation 3.25
|
—
|
|
Part A: Change From Baseline in Respiration Rate in MR Formulation
Day 1, 12 hours; n=15, 16, 12, 16, 12
|
1.1 Breaths per minute
Standard Deviation 1.68
|
0.8 Breaths per minute
Standard Deviation 1.94
|
2.2 Breaths per minute
Standard Deviation 2.25
|
0.9 Breaths per minute
Standard Deviation 2.14
|
2.1 Breaths per minute
Standard Deviation 3.34
|
—
|
|
Part A: Change From Baseline in Respiration Rate in MR Formulation
Day 2, 24 hours; n=16, 16, 12, 16, 12
|
1.4 Breaths per minute
Standard Deviation 1.93
|
0.9 Breaths per minute
Standard Deviation 2.58
|
1.9 Breaths per minute
Standard Deviation 2.43
|
2.2 Breaths per minute
Standard Deviation 1.64
|
0.9 Breaths per minute
Standard Deviation 2.68
|
—
|
|
Part A: Change From Baseline in Respiration Rate in MR Formulation
Day 3, 48 hours; n=16, 16, 12, 16, 12
|
2.3 Breaths per minute
Standard Deviation 3.00
|
0.4 Breaths per minute
Standard Deviation 1.79
|
4.0 Breaths per minute
Standard Deviation 2.37
|
0.7 Breaths per minute
Standard Deviation 1.99
|
-0.4 Breaths per minute
Standard Deviation 2.64
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Body Temperature in IR Formulation
Day 1, 2 hours
|
0.04 Degrees Celsius
Standard Deviation 0.159
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Body Temperature in IR Formulation
Day 1, 12 hours
|
0.13 Degrees Celsius
Standard Deviation 0.241
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Body Temperature in IR Formulation
Day 2, 24 hours
|
0.10 Degrees Celsius
Standard Deviation 0.183
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 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 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Body Temperature in MR Formulation
Day 1, 2 hours
|
-0.04 Degrees Celsius
Standard Deviation 0.216
|
0.14 Degrees Celsius
Standard Deviation 0.190
|
-0.03 Degrees Celsius
Standard Deviation 0.107
|
-0.06 Degrees Celsius
Standard Deviation 0.141
|
-0.04 Degrees Celsius
Standard Deviation 0.211
|
—
|
|
Part A: Change From Baseline in Body Temperature in MR Formulation
Day 1, 12 hours
|
0.12 Degrees Celsius
Standard Deviation 0.180
|
0.15 Degrees Celsius
Standard Deviation 0.266
|
0.11 Degrees Celsius
Standard Deviation 0.162
|
-0.04 Degrees Celsius
Standard Deviation 0.150
|
0.24 Degrees Celsius
Standard Deviation 0.188
|
—
|
|
Part A: Change From Baseline in Body Temperature in MR Formulation
Day 2, 24 hours
|
-0.03 Degrees Celsius
Standard Deviation 0.188
|
0.12 Degrees Celsius
Standard Deviation 0.148
|
0.06 Degrees Celsius
Standard Deviation 0.151
|
0.05 Degrees Celsius
Standard Deviation 0.175
|
0.08 Degrees Celsius
Standard Deviation 0.175
|
—
|
|
Part A: Change From Baseline in Body Temperature in MR Formulation
Day 3, 48 hours
|
-0.05 Degrees Celsius
Standard Deviation 0.163
|
0.01 Degrees Celsius
Standard Deviation 0.247
|
0.04 Degrees Celsius
Standard Deviation 0.156
|
0.01 Degrees Celsius
Standard Deviation 0.178
|
0.07 Degrees Celsius
Standard Deviation 0.222
|
—
|
SECONDARY outcome
Timeframe: Up to Day 67Population: Safety Population.
Single 12-lead ECGs were obtained using an automated ECG machine that calculated PR, QRS, QT and Corrected QT (QTc) intervals. ECG measurements were performed in a semi-supine or supine position. Number of participants with abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation
Abnormal-Not Clinically Significant
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation
Abnormal - Clinically Significant
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 67Population: Safety Population.
Single 12-lead ECGs were obtained using an automated ECG machine that calculated PR, QRS, QT and Corrected QT (QTc) intervals. ECG measurements were performed in a semi-supine or supine position. Number of participants with abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline has been reported.
Outcome measures
| Measure |
Part A: IR 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-18h 240 mg Fasted
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-16h 240 mg Fasted
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part A: MR-12h 240 mg Fed (High-Fat)
n=16 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240 mg Fed (High-fat)
n=12 Participants
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240 mg Fasted
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation
Abnormal-Not Clinically Significant
|
8 Participants
|
10 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation
Abnormal - Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Part A: IR 240 mg Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: MR-12h 240 mg Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: MR-18h 240mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: MR-12h 240mg Fed (High-Fat)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: MR-18h 240mg Fed (High-Fat)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: MR-16h 240mg Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: MR-16h 480mg Fasted
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: MR-16h 480 mg Fed (Std)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: MR-16h 480mg Fed (High-fat)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: MR-16h 960mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: MR-16h 120mg Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: IR 240 mg Fasted
n=16 participants at risk
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
|
Part A: MR-12h 240 mg Fasted
n=16 participants at risk
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
|
Part A: MR-18h 240mg Fasted
n=16 participants at risk
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
|
Part A: MR-12h 240mg Fed (High-Fat)
n=12 participants at risk
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
|
Part A: MR-18h 240mg Fed (High-Fat)
n=16 participants at risk
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
|
Part A: MR-16h 240mg Fasted
n=12 participants at risk
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
|
Part B: MR-16h 480mg Fasted
n=16 participants at risk
Participants received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
|
Part B: MR-16h 480 mg Fed (Std)
n=14 participants at risk
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after a standard breakfast (fed state)
|
Part B: MR-16h 480mg Fed (High-fat)
n=15 participants at risk
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
|
Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
n=14 participants at risk
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
|
Part B: MR-16h 960mg Fasted
n=15 participants at risk
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state
|
Part B: MR-16h 120mg Fasted
n=15 participants at risk
Participants received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
16.7%
2/12 • Number of events 2 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
18.8%
3/16 • Number of events 3 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Application site irritation
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Chest discomfort
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Investigations
Transaminases increased
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
8.3%
1/12 • Number of events 1 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
General disorders
Peripheral swelling
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Investigations
Cardiac murmur
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/16 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 for Part B
Non-serious AEs and SAEs were collected in Safety population.
|
0.00%
0/12 • Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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 67 for Part A and up to Day 68 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