Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2292767 in Healthy Participants Who Smoke Cigarettes (NCT NCT03045887)
NCT ID: NCT03045887
Last Updated: 2019-07-24
Results Overview
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants with 5 percent nSAEs and SAEs has been reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
Up to 12 weeks
Results posted on
2019-07-24
Participant Flow
This is a two part, single site, randomized, double-blind (sponsor open), placebo controlled study in healthy smokers. Study was conducted in the United Kingdom.
Part A comprised of two cohorts, each of which consisted of 3 treatment periods with 4 treatment sequences. Out of 98 screened participants, 37 were randomized, 58 were screen failures and 3 were retained as reserve participants. In Part B, 12 participants were included, 11 of them were taken from Part A and 1 additional participant only for Part B
Participant milestones
| Measure |
Part A: Placebo/200 µg GSK2292767/1000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 1 were administered a single dose of placebo in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA Dry Powder Inhaler (DPI). There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/Placebo/1000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 2 were administered a single dose of 50 µg GSK2292767 in Period 1, placebo in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/200 µg GSK2292767/Placebo
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 3 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/200 µg GSK2292767/1000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 4 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:Placebo/500 µg GSK2292767/2000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 5 were administered a single dose of placebo in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/Placebo/2000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 6 were administered a single dose of 100 ug GSK2292767 in Period 1, placebo in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/500 µg GSK2292767/Placebo
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 7 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/500 µg GSK2292767/2000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 8 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI . There was a period of 4 weeks between doses for an individual participant.
|
Part B:Placebo
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
|
Part B:GSK2292767 2000 µg OD
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A, Period (1 Day)
STARTED
|
7
|
4
|
5
|
5
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A, Period (1 Day)
COMPLETED
|
7
|
4
|
5
|
5
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A, Period (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A,Washout Period 1(4 Weeks)
STARTED
|
7
|
4
|
5
|
5
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A,Washout Period 1(4 Weeks)
COMPLETED
|
4
|
4
|
5
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A,Washout Period 1(4 Weeks)
NOT COMPLETED
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A, Period 2 (1 Day)
STARTED
|
4
|
4
|
5
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A, Period 2 (1 Day)
COMPLETED
|
3
|
4
|
5
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A, Period 2 (1 Day)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A,Washout Period 2 (4 Weeks)
STARTED
|
3
|
4
|
5
|
4
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A,Washout Period 2 (4 Weeks)
COMPLETED
|
3
|
4
|
4
|
2
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A,Washout Period 2 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A, Period 3 (1 Day)
STARTED
|
3
|
4
|
4
|
2
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A, Period 3 (1 Day)
COMPLETED
|
3
|
4
|
4
|
2
|
4
|
4
|
4
|
4
|
0
|
0
|
|
Part A, Period 3 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
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0
|
0
|
|
Part B (14 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
9
|
|
Part B (14 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
9
|
|
Part B (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Placebo/200 µg GSK2292767/1000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 1 were administered a single dose of placebo in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA Dry Powder Inhaler (DPI). There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/Placebo/1000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 2 were administered a single dose of 50 µg GSK2292767 in Period 1, placebo in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/200 µg GSK2292767/Placebo
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 3 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/200 µg GSK2292767/1000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 4 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:Placebo/500 µg GSK2292767/2000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 5 were administered a single dose of placebo in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/Placebo/2000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 6 were administered a single dose of 100 ug GSK2292767 in Period 1, placebo in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/500 µg GSK2292767/Placebo
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 7 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/500 µg GSK2292767/2000 µg GSK2292767
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 8 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI . There was a period of 4 weeks between doses for an individual participant.
|
Part B:Placebo
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
|
Part B:GSK2292767 2000 µg OD
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A,Washout Period 1(4 Weeks)
Physician Decision
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A,Washout Period 1(4 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A, Period 2 (1 Day)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A,Washout Period 2 (4 Weeks)
Physician Decision
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A,Washout Period 2 (4 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2292767 in Healthy Participants Who Smoke Cigarettes
Baseline characteristics by cohort
| Measure |
Part A:Placebo/200 µg GSK2292767/1000 µg GSK2292767
n=7 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 1 were administered a single dose of placebo in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA Dry Powder Inhaler (DPI). There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/Placebo/1000 µg GSK2292767
n=3 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 2 were administered a single dose of 50 µg GSK2292767 in Period 1, placebo in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/200 µg GSK2292767/Placebo
n=5 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 3 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:50 µg GSK2292767/200 µg GSK2292767/1000 µg GSK2292767
n=6 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 4 were administered a single dose of 50 µg GSK2292767 in Period 1, 200 µg GSK2292767 in Period 2 and 1000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:Placebo/500 µg GSK2292767/2000 µg GSK2292767
n=4 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 5 were administered a single dose of placebo in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/Placebo/2000 µg GSK2292767
n=4 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 6 were administered a single dose of 100 ug GSK2292767 in Period 1, placebo in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/500 µg GSK2292767/Placebo
n=4 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 7 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and placebo in Period 3. The treatment was administered via ELLIPTA DPI. There was a period of 4 weeks between doses for an individual participant.
|
Part A:100 µg GSK2292767/500 µg GSK2292767/2000 µg GSK2292767
n=4 Participants
Part A consisted of two cohorts each containing three treatment periods with four treatment sequences. Participants randomized to Sequence 8 were administered a single dose of 100 µg GSK2292767 in Period 1, 500 µg GSK2292767 in Period 2 and 2000 µg GSK2292767 in Period 3. The treatment was administered via ELLIPTA DPI . There was a period of 4 weeks between doses for an individual participant.
|
Part B: Placebo
n=3 Participants
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
|
Part B: GSK2292767 2000 µg OD
n=9 Participants
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
9 Participants
|
48 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
9 Participants
|
49 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
9 Participants
|
46 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Population comprised of all randomized participants who took at least 1 dose of study treatment.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants with 5 percent nSAEs and SAEs has been reported.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Any Non-serious Adverse Event (nSAE) and Any Serious Adverse Event (SAE)
nSAE
|
6 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Part A: Number of Participants With Any Non-serious Adverse Event (nSAE) and Any Serious Adverse Event (SAE)
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants with 5 percent nSAEs and SAEs has been reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Any AE and Any SAE
nSAE
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Any AE and Any SAE
SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment periodPopulation: Safety Population
Blood pressure in part A was assessed in a semi supine position with a completely automated device. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 24 hour
|
-1.3 Millimeters of mercury
Standard Deviation 6.81
|
0.6 Millimeters of mercury
Standard Deviation 6.32
|
1.5 Millimeters of mercury
Standard Deviation 3.90
|
3.6 Millimeters of mercury
Standard Deviation 8.03
|
3.6 Millimeters of mercury
Standard Deviation 4.21
|
-2.9 Millimeters of mercury
Standard Deviation 5.62
|
-0.1 Millimeters of mercury
Standard Deviation 5.12
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 30 min
|
0.3 Millimeters of mercury
Standard Deviation 6.66
|
2.0 Millimeters of mercury
Standard Deviation 6.48
|
2.4 Millimeters of mercury
Standard Deviation 4.91
|
2.0 Millimeters of mercury
Standard Deviation 5.23
|
2.5 Millimeters of mercury
Standard Deviation 6.20
|
-1.6 Millimeters of mercury
Standard Deviation 5.36
|
1.9 Millimeters of mercury
Standard Deviation 3.58
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 1 hour
|
0.8 Millimeters of mercury
Standard Deviation 7.02
|
3.1 Millimeters of mercury
Standard Deviation 4.98
|
3.8 Millimeters of mercury
Standard Deviation 4.65
|
1.2 Millimeters of mercury
Standard Deviation 3.63
|
4.1 Millimeters of mercury
Standard Deviation 4.44
|
-0.9 Millimeters of mercury
Standard Deviation 7.72
|
0.8 Millimeters of mercury
Standard Deviation 5.04
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 6 hour
|
0.1 Millimeters of mercury
Standard Deviation 5.48
|
0.3 Millimeters of mercury
Standard Deviation 7.41
|
1.8 Millimeters of mercury
Standard Deviation 3.84
|
1.9 Millimeters of mercury
Standard Deviation 7.04
|
3.2 Millimeters of mercury
Standard Deviation 6.22
|
-2.0 Millimeters of mercury
Standard Deviation 2.83
|
3.1 Millimeters of mercury
Standard Deviation 7.93
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, 12 hour
|
2.3 Millimeters of mercury
Standard Deviation 6.36
|
3.1 Millimeters of mercury
Standard Deviation 6.72
|
2.9 Millimeters of mercury
Standard Deviation 3.45
|
4.0 Millimeters of mercury
Standard Deviation 7.92
|
2.3 Millimeters of mercury
Standard Deviation 6.41
|
0.7 Millimeters of mercury
Standard Deviation 4.39
|
3.1 Millimeters of mercury
Standard Deviation 7.76
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 30 min
|
-3.2 Millimeters of mercury
Standard Deviation 6.28
|
-0.2 Millimeters of mercury
Standard Deviation 5.06
|
-3.9 Millimeters of mercury
Standard Deviation 9.67
|
0.8 Millimeters of mercury
Standard Deviation 5.16
|
-2.3 Millimeters of mercury
Standard Deviation 6.20
|
-6.1 Millimeters of mercury
Standard Deviation 4.73
|
-3.3 Millimeters of mercury
Standard Deviation 5.85
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 1 hour
|
-3.4 Millimeters of mercury
Standard Deviation 7.72
|
-1.5 Millimeters of mercury
Standard Deviation 4.74
|
-5.6 Millimeters of mercury
Standard Deviation 8.07
|
-3.4 Millimeters of mercury
Standard Deviation 7.01
|
-2.2 Millimeters of mercury
Standard Deviation 6.53
|
-7.1 Millimeters of mercury
Standard Deviation 9.06
|
-3.9 Millimeters of mercury
Standard Deviation 8.38
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 6 hour
|
1.3 Millimeters of mercury
Standard Deviation 8.79
|
0.7 Millimeters of mercury
Standard Deviation 8.23
|
-3.8 Millimeters of mercury
Standard Deviation 9.03
|
4.5 Millimeters of mercury
Standard Deviation 7.92
|
2.8 Millimeters of mercury
Standard Deviation 6.34
|
-0.3 Millimeters of mercury
Standard Deviation 7.48
|
-0.8 Millimeters of mercury
Standard Deviation 5.86
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 12 hour
|
3.9 Millimeters of mercury
Standard Deviation 6.65
|
3.3 Millimeters of mercury
Standard Deviation 6.52
|
-1.3 Millimeters of mercury
Standard Deviation 8.65
|
3.6 Millimeters of mercury
Standard Deviation 4.93
|
5.0 Millimeters of mercury
Standard Deviation 9.53
|
1.6 Millimeters of mercury
Standard Deviation 4.03
|
3.3 Millimeters of mercury
Standard Deviation 7.33
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, 24 hour
|
-0.7 Millimeters of mercury
Standard Deviation 6.19
|
-0.9 Millimeters of mercury
Standard Deviation 7.54
|
-5.3 Millimeters of mercury
Standard Deviation 5.26
|
0.0 Millimeters of mercury
Standard Deviation 8.67
|
-1.5 Millimeters of mercury
Standard Deviation 6.78
|
-4.3 Millimeters of mercury
Standard Deviation 5.74
|
-2.8 Millimeters of mercury
Standard Deviation 5.77
|
PRIMARY outcome
Timeframe: Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14Population: Safety Population
Blood pressure in part B were assessed in semi supine position with a completely automated device. SBP and DBP preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 11, pre-dose
|
-9.3 Millimeters of mercury
Standard Deviation 12.74
|
-2.1 Millimeters of mercury
Standard Deviation 4.46
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 12, pre-dose
|
-7.3 Millimeters of mercury
Standard Deviation 7.51
|
-2.9 Millimeters of mercury
Standard Deviation 4.23
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 2, pre-dose
|
-6.0 Millimeters of mercury
Standard Deviation 10.15
|
-3.0 Millimeters of mercury
Standard Deviation 4.72
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 3, pre-dose
|
-8.3 Millimeters of mercury
Standard Deviation 9.45
|
-1.3 Millimeters of mercury
Standard Deviation 5.85
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 4, pre-dose
|
-7.3 Millimeters of mercury
Standard Deviation 12.10
|
-3.4 Millimeters of mercury
Standard Deviation 4.90
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 5, pre-dose
|
-10.7 Millimeters of mercury
Standard Deviation 11.72
|
-2.2 Millimeters of mercury
Standard Deviation 5.09
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 6, pre-dose
|
-7.7 Millimeters of mercury
Standard Deviation 10.02
|
-3.7 Millimeters of mercury
Standard Deviation 4.72
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 7, pre-dose
|
-8.3 Millimeters of mercury
Standard Deviation 9.45
|
-2.3 Millimeters of mercury
Standard Deviation 3.57
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 8, pre-dose
|
-5.7 Millimeters of mercury
Standard Deviation 12.42
|
-4.3 Millimeters of mercury
Standard Deviation 3.91
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 9, pre-dose
|
-6.3 Millimeters of mercury
Standard Deviation 11.93
|
-2.8 Millimeters of mercury
Standard Deviation 4.02
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 10, pre-dose
|
-8.7 Millimeters of mercury
Standard Deviation 11.93
|
-0.6 Millimeters of mercury
Standard Deviation 6.21
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 13, pre-dose
|
-7.0 Millimeters of mercury
Standard Deviation 10.58
|
-3.0 Millimeters of mercury
Standard Deviation 5.43
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 14, pre-dose
|
-8.3 Millimeters of mercury
Standard Deviation 10.97
|
-3.2 Millimeters of mercury
Standard Deviation 3.83
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP, Day 14, 24 hours
|
-1.3 Millimeters of mercury
Standard Deviation 1.53
|
-1.0 Millimeters of mercury
Standard Deviation 5.17
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 2, pre-dose
|
3.3 Millimeters of mercury
Standard Deviation 11.24
|
-5.4 Millimeters of mercury
Standard Deviation 7.60
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 3, pre-dose
|
-0.7 Millimeters of mercury
Standard Deviation 9.07
|
-0.1 Millimeters of mercury
Standard Deviation 8.70
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 4, pre-dose
|
2.3 Millimeters of mercury
Standard Deviation 10.50
|
-4.1 Millimeters of mercury
Standard Deviation 7.75
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 5, pre-dose
|
-1.0 Millimeters of mercury
Standard Deviation 9.85
|
-5.1 Millimeters of mercury
Standard Deviation 8.74
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 6, pre-dose
|
-1.7 Millimeters of mercury
Standard Deviation 8.50
|
-7.2 Millimeters of mercury
Standard Deviation 7.26
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 7, pre-dose
|
-4.7 Millimeters of mercury
Standard Deviation 5.86
|
-5.0 Millimeters of mercury
Standard Deviation 9.50
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 8, pre-dose
|
-1.3 Millimeters of mercury
Standard Deviation 8.08
|
-7.6 Millimeters of mercury
Standard Deviation 10.01
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 9, pre-dose
|
0.0 Millimeters of mercury
Standard Deviation 3.61
|
-5.8 Millimeters of mercury
Standard Deviation 4.27
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 10, pre-dose
|
-4.7 Millimeters of mercury
Standard Deviation 5.13
|
-5.2 Millimeters of mercury
Standard Deviation 6.65
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 11, pre-dose
|
-6.3 Millimeters of mercury
Standard Deviation 5.51
|
-4.4 Millimeters of mercury
Standard Deviation 9.06
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 12, pre-dose
|
-6.3 Millimeters of mercury
Standard Deviation 4.73
|
-5.4 Millimeters of mercury
Standard Deviation 6.54
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 13, pre-dose
|
2.3 Millimeters of mercury
Standard Deviation 4.93
|
-4.9 Millimeters of mercury
Standard Deviation 6.51
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 14, pre-dose
|
-1.7 Millimeters of mercury
Standard Deviation 7.57
|
-4.6 Millimeters of mercury
Standard Deviation 7.33
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP, Day 14, 24 hours
|
-0.7 Millimeters of mercury
Standard Deviation 2.08
|
-3.7 Millimeters of mercury
Standard Deviation 6.71
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment periodPopulation: Safety Population
Heart rate in part A was assessed in a semi supine position with a completely automated device. Heart rate measurement was preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Heart Rate
1 hour
|
-8.0 Beats per minute
Standard Deviation 5.60
|
-4.8 Beats per minute
Standard Deviation 3.57
|
-9.0 Beats per minute
Standard Deviation 8.90
|
-7.2 Beats per minute
Standard Deviation 5.27
|
-4.3 Beats per minute
Standard Deviation 7.63
|
-13.0 Beats per minute
Standard Deviation 7.98
|
-9.8 Beats per minute
Standard Deviation 7.55
|
|
Part A: Change From Baseline in Heart Rate
6 hour
|
4.3 Beats per minute
Standard Deviation 9.45
|
4.3 Beats per minute
Standard Deviation 5.58
|
1.0 Beats per minute
Standard Deviation 9.55
|
4.9 Beats per minute
Standard Deviation 5.42
|
7.4 Beats per minute
Standard Deviation 6.37
|
-1.3 Beats per minute
Standard Deviation 7.42
|
2.4 Beats per minute
Standard Deviation 7.98
|
|
Part A: Change From Baseline in Heart Rate
12 hour
|
4.2 Beats per minute
Standard Deviation 7.11
|
6.4 Beats per minute
Standard Deviation 7.80
|
-0.3 Beats per minute
Standard Deviation 10.17
|
3.7 Beats per minute
Standard Deviation 6.24
|
3.7 Beats per minute
Standard Deviation 5.85
|
-1.8 Beats per minute
Standard Deviation 8.61
|
5.3 Beats per minute
Standard Deviation 10.38
|
|
Part A: Change From Baseline in Heart Rate
24 hour
|
-2.3 Beats per minute
Standard Deviation 6.24
|
-1.7 Beats per minute
Standard Deviation 6.69
|
-1.8 Beats per minute
Standard Deviation 8.70
|
-3.0 Beats per minute
Standard Deviation 7.23
|
-1.8 Beats per minute
Standard Deviation 8.02
|
-6.9 Beats per minute
Standard Deviation 5.88
|
-4.0 Beats per minute
Standard Deviation 8.18
|
|
Part A: Change From Baseline in Heart Rate
30 min
|
-5.3 Beats per minute
Standard Deviation 5.39
|
-5.8 Beats per minute
Standard Deviation 5.40
|
-8.9 Beats per minute
Standard Deviation 8.46
|
-6.1 Beats per minute
Standard Deviation 5.25
|
-6.3 Beats per minute
Standard Deviation 5.37
|
-12.4 Beats per minute
Standard Deviation 6.80
|
-6.1 Beats per minute
Standard Deviation 7.24
|
PRIMARY outcome
Timeframe: Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14Population: Safety Population
Heart rate in part B was assessed in a semi supine position with a completely automated device. Heart rate measurement was preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Heart Rate
Day 2, pre-dose
|
-0.3 Beats per minute
Standard Deviation 6.11
|
-0.7 Beats per minute
Standard Deviation 7.14
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 3, pre-dose
|
3.0 Beats per minute
Standard Deviation 6.56
|
0.0 Beats per minute
Standard Deviation 6.76
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 4, pre-dose
|
6.7 Beats per minute
Standard Deviation 11.50
|
-2.2 Beats per minute
Standard Deviation 8.03
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 5, pre-dose
|
-2.3 Beats per minute
Standard Deviation 9.45
|
-3.2 Beats per minute
Standard Deviation 9.26
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 6, pre-dose
|
-2.7 Beats per minute
Standard Deviation 8.14
|
-6.4 Beats per minute
Standard Deviation 7.80
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 7, pre-dose
|
3.7 Beats per minute
Standard Deviation 9.07
|
-0.8 Beats per minute
Standard Deviation 11.12
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 8, pre-dose
|
4.7 Beats per minute
Standard Deviation 13.50
|
-3.2 Beats per minute
Standard Deviation 5.85
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 9, pre-dose
|
1.7 Beats per minute
Standard Deviation 5.13
|
-3.4 Beats per minute
Standard Deviation 8.49
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 10, pre-dose
|
1.0 Beats per minute
Standard Deviation 11.79
|
-2.7 Beats per minute
Standard Deviation 10.28
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 11, pre-dose
|
-1.3 Beats per minute
Standard Deviation 14.64
|
-2.8 Beats per minute
Standard Deviation 11.98
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 12, pre-dose
|
-5.7 Beats per minute
Standard Deviation 7.23
|
-4.9 Beats per minute
Standard Deviation 6.47
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 13, pre-dose
|
4.0 Beats per minute
Standard Deviation 15.00
|
-4.4 Beats per minute
Standard Deviation 6.13
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 14, pre-dose
|
6.0 Beats per minute
Standard Deviation 11.27
|
-5.8 Beats per minute
Standard Deviation 9.36
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Heart Rate
Day 14, 24 hours
|
-2.3 Beats per minute
Standard Deviation 7.57
|
-2.2 Beats per minute
Standard Deviation 7.56
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment periodPopulation: Safety Population
Respiratory rate in part A was assessed in a semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Respiratory Rate
30 min
|
-0.2 Breaths per minute
Standard Deviation 1.78
|
-1.1 Breaths per minute
Standard Deviation 2.81
|
-1.5 Breaths per minute
Standard Deviation 1.98
|
0.8 Breaths per minute
Standard Deviation 2.48
|
0.3 Breaths per minute
Standard Deviation 2.01
|
0.3 Breaths per minute
Standard Deviation 2.74
|
-0.2 Breaths per minute
Standard Deviation 1.95
|
|
Part A: Change From Baseline in Respiratory Rate
1 hour
|
-0.3 Breaths per minute
Standard Deviation 2.27
|
-1.0 Breaths per minute
Standard Deviation 2.76
|
-1.2 Breaths per minute
Standard Deviation 2.17
|
0.8 Breaths per minute
Standard Deviation 2.03
|
0.6 Breaths per minute
Standard Deviation 2.23
|
-0.3 Breaths per minute
Standard Deviation 2.35
|
-0.8 Breaths per minute
Standard Deviation 2.41
|
|
Part A: Change From Baseline in Respiratory Rate
6 hour
|
0.1 Breaths per minute
Standard Deviation 2.18
|
0.0 Breaths per minute
Standard Deviation 3.67
|
1.0 Breaths per minute
Standard Deviation 1.95
|
1.0 Breaths per minute
Standard Deviation 2.97
|
0.8 Breaths per minute
Standard Deviation 3.33
|
0.6 Breaths per minute
Standard Deviation 2.74
|
0.3 Breaths per minute
Standard Deviation 2.23
|
|
Part A: Change From Baseline in Respiratory Rate
12 hour
|
0.7 Breaths per minute
Standard Deviation 2.31
|
0.7 Breaths per minute
Standard Deviation 3.11
|
-0.4 Breaths per minute
Standard Deviation 2.43
|
1.3 Breaths per minute
Standard Deviation 2.14
|
0.6 Breaths per minute
Standard Deviation 2.75
|
0.3 Breaths per minute
Standard Deviation 2.55
|
-0.3 Breaths per minute
Standard Deviation 1.86
|
|
Part A: Change From Baseline in Respiratory Rate
24 hour
|
-0.6 Breaths per minute
Standard Deviation 2.29
|
-0.9 Breaths per minute
Standard Deviation 3.20
|
-1.0 Breaths per minute
Standard Deviation 2.63
|
0.4 Breaths per minute
Standard Deviation 2.50
|
-0.8 Breaths per minute
Standard Deviation 2.08
|
-0.8 Breaths per minute
Standard Deviation 3.15
|
-0.4 Breaths per minute
Standard Deviation 1.68
|
PRIMARY outcome
Timeframe: Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14Population: Safety Population
Respiratory rate in part B was assessed in a semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Respiratory Rate
Day 2, pre-dose
|
-2.3 Breaths per minute
Standard Deviation 0.58
|
-0.6 Breaths per minute
Standard Deviation 3.17
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 3, pre-dose
|
-2.3 Breaths per minute
Standard Deviation 2.31
|
-1.0 Breaths per minute
Standard Deviation 3.20
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 4, pre-dose
|
-2.3 Breaths per minute
Standard Deviation 2.08
|
-0.3 Breaths per minute
Standard Deviation 2.96
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 5, pre-dose
|
-2.7 Breaths per minute
Standard Deviation 2.31
|
-1.4 Breaths per minute
Standard Deviation 2.65
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 6, pre-dose
|
-2.7 Breaths per minute
Standard Deviation 0.58
|
-1.6 Breaths per minute
Standard Deviation 2.92
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 7, pre-dose
|
-2.3 Breaths per minute
Standard Deviation 2.31
|
-0.8 Breaths per minute
Standard Deviation 2.59
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 8, pre-dose
|
-2.7 Breaths per minute
Standard Deviation 0.58
|
-0.7 Breaths per minute
Standard Deviation 2.45
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 9, pre-dose
|
-2.0 Breaths per minute
Standard Deviation 2.00
|
0.1 Breaths per minute
Standard Deviation 2.98
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 10, pre-dose
|
-1.7 Breaths per minute
Standard Deviation 2.31
|
-1.2 Breaths per minute
Standard Deviation 2.54
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 11, pre-dose
|
-3.3 Breaths per minute
Standard Deviation 0.58
|
-0.9 Breaths per minute
Standard Deviation 3.62
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 12, pre-dose
|
-2.3 Breaths per minute
Standard Deviation 1.15
|
-1.0 Breaths per minute
Standard Deviation 2.74
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 13, pre-dose
|
-1.3 Breaths per minute
Standard Deviation 1.15
|
-0.1 Breaths per minute
Standard Deviation 3.06
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 14, pre-dose
|
-2.0 Breaths per minute
Standard Deviation 1.73
|
-1.1 Breaths per minute
Standard Deviation 2.89
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Respiratory Rate
Day 14, 24 hours
|
-2.3 Breaths per minute
Standard Deviation 1.53
|
-1.1 Breaths per minute
Standard Deviation 2.26
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment periodPopulation: Safety Population
Tympanic temperature in part A was assessed in semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Tympanic Temperature
30 min
|
0.03 Celsius
Standard Deviation 0.313
|
0.07 Celsius
Standard Deviation 0.210
|
0.04 Celsius
Standard Deviation 0.574
|
0.05 Celsius
Standard Deviation 0.395
|
-0.05 Celsius
Standard Deviation 0.366
|
0.03 Celsius
Standard Deviation 0.287
|
0.16 Celsius
Standard Deviation 0.385
|
|
Part A: Change From Baseline in Tympanic Temperature
1 hour
|
-0.10 Celsius
Standard Deviation 0.348
|
0.06 Celsius
Standard Deviation 0.173
|
0.05 Celsius
Standard Deviation 0.498
|
-0.06 Celsius
Standard Deviation 0.287
|
0.05 Celsius
Standard Deviation 0.478
|
0.12 Celsius
Standard Deviation 0.311
|
0.10 Celsius
Standard Deviation 0.449
|
|
Part A: Change From Baseline in Tympanic Temperature
6 hour
|
0.20 Celsius
Standard Deviation 0.390
|
0.08 Celsius
Standard Deviation 0.259
|
0.18 Celsius
Standard Deviation 0.566
|
0.07 Celsius
Standard Deviation 0.446
|
0.17 Celsius
Standard Deviation 0.409
|
0.14 Celsius
Standard Deviation 0.361
|
0.19 Celsius
Standard Deviation 0.493
|
|
Part A: Change From Baseline in Tympanic Temperature
12 hour
|
0.14 Celsius
Standard Deviation 0.478
|
0.31 Celsius
Standard Deviation 0.370
|
0.27 Celsius
Standard Deviation 0.542
|
0.26 Celsius
Standard Deviation 0.355
|
0.20 Celsius
Standard Deviation 0.591
|
0.46 Celsius
Standard Deviation 0.400
|
0.18 Celsius
Standard Deviation 0.622
|
|
Part A: Change From Baseline in Tympanic Temperature
24 hour
|
-0.06 Celsius
Standard Deviation 0.375
|
-0.02 Celsius
Standard Deviation 0.233
|
-0.02 Celsius
Standard Deviation 0.513
|
0.03 Celsius
Standard Deviation 0.287
|
0.07 Celsius
Standard Deviation 0.392
|
0.11 Celsius
Standard Deviation 0.326
|
0.02 Celsius
Standard Deviation 0.497
|
PRIMARY outcome
Timeframe: Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14Population: Safety Population
Tympanic temperature in part B was assessed in semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Tympanic Temperature
Day 2, pre-dose
|
0.17 Celsius
Standard Deviation 0.058
|
0.26 Celsius
Standard Deviation 0.477
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 3, pre-dose
|
0.03 Celsius
Standard Deviation 0.379
|
0.37 Celsius
Standard Deviation 0.450
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 4, pre-dose
|
0.13 Celsius
Standard Deviation 0.153
|
0.26 Celsius
Standard Deviation 0.416
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 5, pre-dose
|
0.13 Celsius
Standard Deviation 0.404
|
0.34 Celsius
Standard Deviation 0.445
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 6, pre-dose
|
0.10 Celsius
Standard Deviation 0.265
|
0.31 Celsius
Standard Deviation 0.322
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 7, pre-dose
|
-0.10 Celsius
Standard Deviation 0.100
|
0.41 Celsius
Standard Deviation 0.448
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 8, pre-dose
|
-0.27 Celsius
Standard Deviation 0.231
|
0.29 Celsius
Standard Deviation 0.462
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 9, pre-dose
|
-0.03 Celsius
Standard Deviation 0.153
|
0.21 Celsius
Standard Deviation 0.326
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 10, pre-dose
|
0.13 Celsius
Standard Deviation 0.451
|
0.31 Celsius
Standard Deviation 0.392
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 11, pre-dose
|
0.13 Celsius
Standard Deviation 0.306
|
0.34 Celsius
Standard Deviation 0.343
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 12, pre-dose
|
0.00 Celsius
Standard Deviation 0.265
|
0.32 Celsius
Standard Deviation 0.415
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 13, pre-dose
|
0.07 Celsius
Standard Deviation 0.513
|
0.33 Celsius
Standard Deviation 0.466
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 14, pre-dose
|
0.17 Celsius
Standard Deviation 0.115
|
0.32 Celsius
Standard Deviation 0.458
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Tympanic Temperature
Day 14, 24 hours
|
0.17 Celsius
Standard Deviation 0.115
|
0.32 Celsius
Standard Deviation 0.502
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose and 1 hour)Population: Safety Population
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry at the indicated time. FEV1 measurements were repeated until three technically acceptable measurements (within 150 milliliter \[mL\] of each other) were made. Data for FEV1 for part A is presented here.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Pre-dose
|
4.389 Liters
Standard Deviation 0.6781
|
4.044 Liters
Standard Deviation 0.6717
|
4.768 Liters
Standard Deviation 0.8348
|
3.896 Liters
Standard Deviation 0.7292
|
4.288 Liters
Standard Deviation 0.5288
|
4.036 Liters
Standard Deviation 0.4806
|
4.391 Liters
Standard Deviation 0.5072
|
|
Part A: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
1 hour
|
4.347 Liters
Standard Deviation 0.6781
|
4.028 Liters
Standard Deviation 0.7177
|
4.461 Liters
Standard Deviation 0.4693
|
3.811 Liters
Standard Deviation 0.6757
|
4.223 Liters
Standard Deviation 0.5153
|
4.024 Liters
Standard Deviation 0.5971
|
4.435 Liters
Standard Deviation 0.5851
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety Population
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry at the indicated time. Existing spirometry equipment was used. FEV1 measurements were repeated until three technically acceptable measurements (within 150 mL of each other) were made. Data for FEV1 for part B is presented here.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 11,pre-dose
|
4.423 Liters
Standard Deviation 0.1422
|
4.570 Liters
Standard Deviation 0.7944
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 11,1 hour
|
4.463 Liters
Standard Deviation 0.2540
|
4.609 Liters
Standard Deviation 0.7460
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 12,pre-dose
|
4.417 Liters
Standard Deviation 0.1258
|
4.599 Liters
Standard Deviation 0.7469
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 12,1 hour
|
4.440 Liters
Standard Deviation 0.0917
|
4.600 Liters
Standard Deviation 0.7029
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 13,pre-dose
|
4.400 Liters
Standard Deviation 0.2252
|
4.514 Liters
Standard Deviation 0.7352
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 13,1 hour
|
4.653 Liters
Standard Deviation 0.2146
|
4.768 Liters
Standard Deviation 0.7609
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 14,pre-dose
|
4.533 Liters
Standard Deviation 0.0666
|
4.541 Liters
Standard Deviation 0.8512
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 14,1 hour
|
4.557 Liters
Standard Deviation 0.1701
|
4.609 Liters
Standard Deviation 0.8102
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day -1
|
4.333 Liters
Standard Deviation 0.1739
|
4.570 Liters
Standard Deviation 0.6275
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 1,pre-dose
|
4.277 Liters
Standard Deviation 0.0987
|
4.408 Liters
Standard Deviation 0.6852
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 1,1 hour
|
4.323 Liters
Standard Deviation 0.0981
|
4.413 Liters
Standard Deviation 0.6931
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 2,pre-dose
|
4.357 Liters
Standard Deviation 0.0551
|
4.446 Liters
Standard Deviation 0.7230
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 2,1 hour
|
4.373 Liters
Standard Deviation 0.0569
|
4.486 Liters
Standard Deviation 0.6828
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 3,pre-dose
|
4.407 Liters
Standard Deviation 0.1504
|
4.474 Liters
Standard Deviation 0.6999
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 3,1 hour
|
4.460 Liters
Standard Deviation 0.2771
|
4.493 Liters
Standard Deviation 0.6548
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 4,pre-dose
|
4.447 Liters
Standard Deviation 0.1159
|
4.483 Liters
Standard Deviation 0.7241
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 4,1 hour
|
4.307 Liters
Standard Deviation 0.1060
|
4.519 Liters
Standard Deviation 0.7444
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 5,pre-dose
|
4.290 Liters
Standard Deviation 0.1082
|
4.494 Liters
Standard Deviation 0.8042
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 5,1 hour
|
4.480 Liters
Standard Deviation 0.2600
|
4.486 Liters
Standard Deviation 0.7647
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 6,pre-dose
|
4.300 Liters
Standard Deviation 0.0173
|
4.498 Liters
Standard Deviation 0.7086
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 6,1 hour
|
4.533 Liters
Standard Deviation 0.3177
|
4.573 Liters
Standard Deviation 0.7994
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 7,pre-dose
|
4.467 Liters
Standard Deviation 0.2386
|
4.503 Liters
Standard Deviation 0.8559
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 7,1 hour
|
4.400 Liters
Standard Deviation 0.2207
|
4.581 Liters
Standard Deviation 0.8018
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 8,pre-dose
|
4.383 Liters
Standard Deviation 0.0351
|
4.449 Liters
Standard Deviation 0.7952
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 8,1 hour
|
4.440 Liters
Standard Deviation 0.1229
|
4.572 Liters
Standard Deviation 0.6952
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 9,pre-dose
|
4.483 Liters
Standard Deviation 0.2458
|
4.512 Liters
Standard Deviation 0.7483
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 9,1 hour
|
4.470 Liters
Standard Deviation 0.1179
|
4.627 Liters
Standard Deviation 0.7737
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 10,pre-dose
|
4.443 Liters
Standard Deviation 0.1419
|
4.473 Liters
Standard Deviation 0.6942
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Day 10,1 hour
|
4.583 Liters
Standard Deviation 0.1914
|
4.582 Liters
Standard Deviation 0.7609
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose and 1 hour)Population: Safety Population. Data was not collected for this outcome as FVC was used only at screening and no further analysis during the study was required.
FVC is a measure of lung function and is defined as total amount of air that can be exhaled during FEV1 test. FVC was planned to measured using spirometry. The FVC need to be normal at screening and is part of the Forced Expiratory ratio (FEV1/FVC) which should lie between 0.7-0.8 to indicate no chronic obstruction or restriction. The FVC was therefore only used at screening and requires no ongoing analysis during the study. All other indications of obstruction in the study, e.g. paradoxical bronchospasm was provided by the FEV1. The FVC therefore require no analysis.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 (pre-dose and 1 hour)Population: Safety Population. Data was not collected for this outcome as FVC was used only at screening and no further analysis during the study was required.
FVC is a measure of lung function and is defined as total amount of air that can be exhaled during FEV1 test. FVC was planned to measured using spirometry. The FVC need to be normal at screening and is part of the Forced Expiratory ratio (FEV1/FVC) which should lie between 0.7-0.8 to indicate no chronic obstruction or restriction. The FVC was therefore only used at screening and requires no ongoing analysis during the study. All other indications of obstruction in the study, e.g. paradoxical bronchospasm was provided by the FEV1. The FVC therefore require no analysis.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1 of each treatment periodPopulation: Safety Population
Triplicate/Single 12-lead ECG was obtained using an automated ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTFc intervals. Number of participants with abnormal clinically significant and abnormal-not clinically significant values at any time post-Baseline is presented.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Electrocardiogram (ECG) Abnormalities
Abnormal - not clinically significant
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Electrocardiogram (ECG) Abnormalities
Abnormal - clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14Population: Safety Population
Triplicate/Single 12-lead ECG was obtained using an automated ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTFc intervals. Number of participants with abnormal clinically significant and abnormal-not clinically significant values at any time post-Baseline is presented.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With ECG Abnormalities
Abnormal - not clinically significant
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With ECG Abnormalities
Abnormal - clinically significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dose in each treatment period.Population: Safety Population
Number of participants with clinical chemistry values that changed from normal to high or low in part A are presented. Chemistry parameters for which PCC values were identified were: Alkaline Phosphatase, Alanine Amino Transferase, aspartate aminotransferase, Total Bilirubin, calcium, glucose, potassium and Sodium.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Sodium; to low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Alkaline Phosphatase; to high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Alanine Amino Transferase; to high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Aspartate Amino Transferase; to high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Total Bilirubin; to high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Calcium; to high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Calcium; to low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Glucose; to high
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Glucose; to low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Potassium; to high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Potassium; to low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Sodium; to high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Days 2, 4, 6, 8, 10, 12, and 14, 24 hours post-dose on Day 14Population: Safety Population
Number of participants with clinical chemistry values that changed from normal to high or low in part B are presented. Chemistry parameters for which PCC values were identified were: Alkaline Phosphatase, Alanine Amino Transferase, aspartate aminotransferase, Total Bilirubin, calcium, glucose, potassium and Sodium. Only participants with data available at specified time points were analyzed (represented by n=X in category titles)
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 8;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 8, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 10;to high,,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 10,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 12;to high,,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 12,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 14,pre dose,to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 14,pre dose,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 8;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 12;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 6,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 2;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 4;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 6;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 8;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 10;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 12;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 14,pre-dose;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alkaline Phosphatase,Day 14,24 hour;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 2;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 4;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 6;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 8;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 10;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 12;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 14,pre dose;to n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Alanine Amino Transferase,Day 14,24 hour;to hn=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 2;to high,n=3,8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 4;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 6;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 8;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 10;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 12;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 6;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 14,pre dose;n=2,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Aspartate Amino Transferase,Day 14,24 hour,n=3,8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 2,;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 4;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 6;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 8;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 10;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 12;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 14,pre dose,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Total Bilirubin,Day 14,24 hours,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 2;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 2;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 4;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 4;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 6;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 6;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 8;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 10;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 10;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 12;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 14,pre dose,to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 14,pre dose,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 14,24 hour,to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Calcium,Day 14,24 hour,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 2;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 2;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 4;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 4;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 6;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 6;to low, n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 8;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 8;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 10;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 10;to low,,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 12;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 12;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 14;pre dose,to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 14;pre dose,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 14;24 hours,to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Glucose,Day 14;24 hours,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 2;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 2;to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 4;to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 4,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 14,24 hour ,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Potassium,Day 14,24 hour,to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 2, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 2, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 4, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 4, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 6, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 6, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 8, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 8, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 10, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 10, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 12, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 12, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 14,pre dose, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 14,pre dose, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 14,24 hour, to high,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Clinical Chemistry Values of PCC
Sodium,Day 14,24 hour, to low,n=3,9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post-dose in each treatment periodPopulation: Safety Population
Number of participants with hematology parameters of PCC which shifted from normal to high in part A are presented. Hematology parameters for which PCC values were identified were: Hemoglobin, Hematocrit, Lymphocytes, Total Neutrophils, Platelet count and White Blood Cell (WBC) Count. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=13 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=12 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=9 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
n=12 Participants
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Hematology Values of PCC
Hemoglobin; to high,n=23,12,12,13,12,9,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Hematology Values of PCC
Hematocrit; to high,n=23,12,12,13,12,9,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Hematology Values of PCC
Lymphocytes; to low,n=23,12,12,13,12,9,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Hematology Values of PCC
Total Neutrophils; to low,n=23,12,12,13,12,9,12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Hematology Values of PCC
Platelet count;to high;n=23, 12, 11, 13, 11, 9, 11
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Hematology Values of PCC
Platelet count; to low;n=23, 12, 11, 13, 11, 9, 11
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Hematology Values of PCC
WBC count,to high,n=23, 12, 12, 13, 12, 9, 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Hematology Values of PCC
WBC count,to low,n=23, 12, 12, 13, 12, 9, 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Pre-dose on Days 2, 4, 6, 8, 10, 12, and 14, 24 hours post-dose on Day 14Population: Safety Population
Number of participants with hematology parameters of PCC which shifted from normal to high in part B are presented. Hematology parameters for which PCC values were identified were: Hemoglobin, Hematocrit, Lymphocytes, Total Neutrophils, Platelet count and WBC count
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=9 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 10
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 12
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 14,pre dose
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hemoglobin,Day 14,24 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 10
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 12
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 14,pre dose
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Hematocrit,Day 14,24 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 10
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 12
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 14,pre dose
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Lymphocytes,Day 14,24 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 10
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 12
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 14,pre dose
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Total Neutrophils,Day 14,24 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 10
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 12
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 14,pre dose
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
Platelet count,Day 14,24 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 8
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 10
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 12
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 14,pre dose
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Number of Participants With Hematology Values of PCC
WBC count,Day 14,24 hour
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (5 minutes (min), 30 min, 45 min, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periodsPopulation: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for AUC (0 to t), AUC (0 to 24) and AUC (0 to inf) of GSK2292767 for part A is presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Pharmacokinetic population comprised of participants in the 'All participant' population for whom a pharmacokinetic sample was obtained and analyzed.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=13 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=12 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=9 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=12 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2292767
AUC (0-24);n=0,2,5,10,8,11
|
—
|
596.1161 Hours*picograms per milliliter
Geometric Coefficient of Variation 10.0
|
721.9301 Hours*picograms per milliliter
Geometric Coefficient of Variation 57.9
|
2460.3695 Hours*picograms per milliliter
Geometric Coefficient of Variation 70.3
|
3689.7545 Hours*picograms per milliliter
Geometric Coefficient of Variation 36.0
|
7781.2593 Hours*picograms per milliliter
Geometric Coefficient of Variation 52.5
|
—
|
|
Part A: Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2292767
AUC(0-inf);n=0,2,5,7,6,10
|
—
|
596.4042 Hours*picograms per milliliter
Geometric Coefficient of Variation 10.1
|
724.6058 Hours*picograms per milliliter
Geometric Coefficient of Variation 57.8
|
2211.9120 Hours*picograms per milliliter
Geometric Coefficient of Variation 81.5
|
3709.6509 Hours*picograms per milliliter
Geometric Coefficient of Variation 40.6
|
8383.6427 Hours*picograms per milliliter
Geometric Coefficient of Variation 57.8
|
—
|
|
Part A: Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2292767
AUC (0-t);n=12,12,12,12,9,12
|
69.5822 Hours*picograms per milliliter
Geometric Coefficient of Variation 133.1
|
337.0775 Hours*picograms per milliliter
Geometric Coefficient of Variation 48.3
|
633.3267 Hours*picograms per milliliter
Geometric Coefficient of Variation 59.6
|
2164.3817 Hours*picograms per milliliter
Geometric Coefficient of Variation 72.3
|
3440.6354 Hours*picograms per milliliter
Geometric Coefficient of Variation 37.1
|
7758.9831 Hours*picograms per milliliter
Geometric Coefficient of Variation 50.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14Population: Pharmacokinetic population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for AUC (0 to t), AUC (0 to 24) and AUC (0 to inf) of GSK2292767 for part B is presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767
AUC (0-24); Day 1; n=8
|
8163.4986 Hours*picograms per milliliter
Geometric Coefficient of Variation 71.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767
AUC (0-24); Day 14; n=9
|
9941.5681 Hours*picograms per milliliter
Geometric Coefficient of Variation 53.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767
AUC(0-inf); Day 1; n=7
|
10162.0636 Hours*picograms per milliliter
Geometric Coefficient of Variation 66.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767
AUC(0-inf);Day 14; n=7
|
13798.7637 Hours*picograms per milliliter
Geometric Coefficient of Variation 66.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767
AUC (0-t); Day 1; n=9
|
7506.5587 Hours*picograms per milliliter
Geometric Coefficient of Variation 72.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767
AUC (0-t); Day 14; n=9
|
11861.0783 Hours*picograms per milliliter
Geometric Coefficient of Variation 59.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (5 min, 30 min, 45 min, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periodsPopulation: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Five min post dose concentrations on Days 2-13 were assumed to be the Cmax values. Data for Cmax of GSK2292767 for part A is presented. Cmax is defined as maximum observed plasma concentration of GSK2292767.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=12 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=9 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=12 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Plasma Drug Concentration (Cmax) of GSK2292767
|
36.9018 Picograms per milliliter
Geometric Coefficient of Variation 31.9
|
90.8927 Picograms per milliliter
Geometric Coefficient of Variation 30.6
|
170.7836 Picograms per milliliter
Geometric Coefficient of Variation 43.7
|
356.0719 Picograms per milliliter
Geometric Coefficient of Variation 39.4
|
579.8303 Picograms per milliliter
Geometric Coefficient of Variation 39.5
|
1325.3877 Picograms per milliliter
Geometric Coefficient of Variation 44.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Five minute post dose concentrations on Days 2-13 were assumed to be the Cmax values. Data for Cmax of GSK2292767 for part B is presented.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Cmax of GSK2292767
Day 1
|
1145.7369 Picograms per milliliter
Geometric Coefficient of Variation 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 2
|
804.0363 Picograms per milliliter
Geometric Coefficient of Variation 40.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 3
|
871.6343 Picograms per milliliter
Geometric Coefficient of Variation 38.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 4
|
836.4375 Picograms per milliliter
Geometric Coefficient of Variation 36.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 5
|
764.7799 Picograms per milliliter
Geometric Coefficient of Variation 35.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 6
|
785.9632 Picograms per milliliter
Geometric Coefficient of Variation 49.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 7
|
877.1960 Picograms per milliliter
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 8
|
780.2829 Picograms per milliliter
Geometric Coefficient of Variation 42.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 9
|
745.6613 Picograms per milliliter
Geometric Coefficient of Variation 35.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 10
|
829.2395 Picograms per milliliter
Geometric Coefficient of Variation 41.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 11
|
952.5536 Picograms per milliliter
Geometric Coefficient of Variation 40.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 12
|
881.2328 Picograms per milliliter
Geometric Coefficient of Variation 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 13
|
888.9151 Picograms per milliliter
Geometric Coefficient of Variation 42.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax of GSK2292767
Day 14
|
1305.8068 Picograms per milliliter
Geometric Coefficient of Variation 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (5 min, 30 min, 45 min, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periodsPopulation: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Tmax of GSK2292767 for part A is presented.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=12 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=12 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=12 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=9 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=12 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK2292767
|
1.0046 Hours
Interval 0.083 to 3.006
|
0.7540 Hours
Interval 0.086 to 4.002
|
0.7500 Hours
Interval 0.085 to 3.006
|
0.7583 Hours
Interval 0.085 to 4.001
|
1.0264 Hours
Interval 0.509 to 2.0
|
1.0125 Hours
Interval 0.502 to 3.01
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Tmax of GSK2292767 for part B is presented.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Tmax of GSK2292767
Day 1
|
1.0056 Hours
Interval 0.083 to 4.004
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Tmax of GSK2292767
Day 14
|
1.0050 Hours
Interval 0.085 to 3.008
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (5 min, 30 min, 45 min, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periodsPopulation: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for T1/2 of GSK2292767 for part A is presented. T1/2 is defined as the time required for one half of the total amount of a particular substance in a biological system to be degraded by biological processes. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Placebo
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
n=2 Participants
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
n=5 Participants
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=7 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=6 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=10 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Terminal Half-life (T1/2) of GSK2292767
|
—
|
1.6658 Hours
Geometric Coefficient of Variation 32.1
|
2.3157 Hours
Geometric Coefficient of Variation 16.9
|
3.9789 Hours
Geometric Coefficient of Variation 57.6
|
3.1712 Hours
Geometric Coefficient of Variation 30.2
|
6.3179 Hours
Geometric Coefficient of Variation 35.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for T1/2 of GSK2292767 for part B is presented. T1/2 was defined as the time required for one half of the total amount of a particular substance in a biological system to be degraded by biological processes. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: T1/2 of GSK2292767
Day 1
|
6.4625 Hours
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: T1/2 of GSK2292767
Day 14
|
11.7665 Hours
Geometric Coefficient of Variation 48.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hr post dose in each of the 3 treatment periodsPopulation: Pharmacokinetic population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Ctau of GSK2292767 for part A is presented. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered.
Outcome measures
| Measure |
Placebo
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
n=6 Participants
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
n=3 Participants
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
n=11 Participants
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part A: Trough Concentrations (Ctau) of GSK2292767
|
—
|
—
|
—
|
43.5566 Picograms per milliliter
Geometric Coefficient of Variation 65.9
|
44.1985 Picograms per milliliter
Geometric Coefficient of Variation 46.4
|
71.6727 Picograms per milliliter
Geometric Coefficient of Variation 55.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Ctau of GSK2292767 for part B is presented. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Ctau of GSK2292767
Day 1;n=8
|
78.4862 Pico grams per milliliter
Geometric Coefficient of Variation 91.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 2;n=9
|
103.4247 Pico grams per milliliter
Geometric Coefficient of Variation 83.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 3;n=9
|
98.3515 Pico grams per milliliter
Geometric Coefficient of Variation 84.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 4;n=9
|
112.5132 Pico grams per milliliter
Geometric Coefficient of Variation 83.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 5;n=9
|
98.4430 Pico grams per milliliter
Geometric Coefficient of Variation 87.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 6;n=9
|
106.6896 Pico grams per milliliter
Geometric Coefficient of Variation 96.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 7;n=9
|
101.1219 Pico grams per milliliter
Geometric Coefficient of Variation 88.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 8;n=8
|
116.9160 Pico grams per milliliter
Geometric Coefficient of Variation 62.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 9;n=9
|
105.3676 Pico grams per milliliter
Geometric Coefficient of Variation 81.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 10;n=9
|
117.8348 Pico grams per milliliter
Geometric Coefficient of Variation 80.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 11;n=9
|
112.3146 Pico grams per milliliter
Geometric Coefficient of Variation 66.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 12;n=8
|
129.6370 Pico grams per milliliter
Geometric Coefficient of Variation 62.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 13;n=8
|
154.5480 Pico grams per milliliter
Geometric Coefficient of Variation 52.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Ctau of GSK2292767
Day 14;n=9
|
138.2161 Pico grams per milliliter
Geometric Coefficient of Variation 96.7
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Pharmacokinetic Population
BAL samples were collected by bronchoscopy.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Concentration of GSK2292767 in Bronchoalveolar Lavage (BAL)
|
8852.94 Picograms per milliliter
Geometric Coefficient of Variation 236.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15Population: Pharmacokinetic Population
ELF from the lung was extracted from BAL samples. ELF drug concentration was calculated as BAL fluid drug concentration multiplied by dilution factor where dilution factor = Plasma urea (pre-bronchoscopy) divided by BAL urea. NA indicates data not available. Only participants with data available at specified time points were analyzed (represented by n=X in category titles).
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
50 µg OD
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
100 µg OD
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
200 µg OD
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
500 µg OD
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
1000 µg OD
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
2000 µg OD
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|
|
Part B: Concentration of GSK2292767 in Lung Epithelial Lining Fluid (ELF)
24 Hr Wash 2,n=8
|
9777.25 Picograms per milliliters
Geometric Coefficient of Variation 290.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Concentration of GSK2292767 in Lung Epithelial Lining Fluid (ELF)
24 Hr Wash 3,n=7
|
11921.13 Picograms per milliliters
Geometric Coefficient of Variation 251.4
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 50 µg OD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part A: 100 µg OD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 200 µg OD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: 500 µg OD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 1000 µg OD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: 2000 µg OD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: 2000ug OD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=23 participants at risk
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
|
Part A: 50 µg OD
n=12 participants at risk
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
Part A: 100 µg OD
n=12 participants at risk
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
Part A: 200 µg OD
n=13 participants at risk
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
Part A: 500 µg OD
n=12 participants at risk
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
Part A: 1000 µg OD
n=9 participants at risk
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
Part A: 2000 µg OD
n=12 participants at risk
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
|
Part B: Placebo
n=3 participants at risk
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
|
Part B: 2000ug OD
n=9 participants at risk
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
|
|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Eye disorders
Visual impairment
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Chest discomfort
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Chills
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Feeling cold
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Malaise
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Immune system disorders
Seasonal allergy
|
4.3%
1/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Infections and infestations
Viral infection
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Investigations
Hepatic enzyme increased
|
4.3%
1/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
1/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
15.4%
2/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
33.3%
4/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
7.7%
1/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
22.2%
2/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
22.2%
2/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Suffocation feeling
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
13.0%
3/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
16.7%
2/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
15.4%
2/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
33.3%
1/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
44.4%
4/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
8.3%
1/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Catheter site bruise
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Catheter site haematoma
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Chest pain
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
33.3%
3/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Investigations
Bronchoscopy abnormal
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
100.0%
3/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
22.2%
2/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Investigations
Sputum abnormal
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
33.3%
1/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/23 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/13 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/12 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
0.00%
0/3 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs and SAEs were collected in Safety Population
|
11.1%
1/9 • nSAEs and SAEs were collected from start of study treatment up to 16 weeks
nSAEs 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