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Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2292767 in Healthy Participants Who Smoke Cigarettes

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ClinicalTrials.gov Identifier: NCT03045887
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: GSK2292767 50 μg
Drug: GSK2292767 500 μg
Drug: Placebo
Enrollment 38
Recruitment Details 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.
Pre-assignment Details 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
Arm/Group Title Part A: Placebo/200 µg GSK2292767/1000 µg GSK2292767 Part A:50 µg GSK2292767/Placebo/1000 µg GSK2292767 Part A:50 µg GSK2292767/200 µg GSK2292767/Placebo Part A:50 µg GSK2292767/200 µg GSK2292767/1000 µg GSK2292767 Part A:Placebo/500 µg GSK2292767/2000 µg GSK2292767 Part A:100 µg GSK2292767/Placebo/2000 µg GSK2292767 Part A:100 µg GSK2292767/500 µg GSK2292767/Placebo Part A:100 µg GSK2292767/500 µg GSK2292767/2000 µg GSK2292767 Part B:Placebo Part B:GSK2292767 2000 µg OD
Hide Arm/Group Description 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 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 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 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 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 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 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 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. Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Period Title: Part A, Period (1 Day)
Started 7 4 5 5 4 4 4 4 0 0
Completed 7 4 5 5 4 4 4 4 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Part A,Washout Period 1(4 Weeks)
Started 7 4 5 5 4 4 4 4 0 0
Completed 4 4 5 4 4 4 4 4 0 0
Not Completed 3 0 0 1 0 0 0 0 0 0
Reason Not Completed
Physician Decision             3             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             1             0             0             0             0             0             0
Period Title: Part A, Period 2 (1 Day)
Started 4 4 5 4 4 4 4 4 0 0
Completed 3 4 5 4 4 4 4 4 0 0
Not Completed 1 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0             0             0             0             0
Period Title: Part A,Washout Period 2 (4 Weeks)
Started 3 4 5 4 4 4 4 4 0 0
Completed 3 4 4 2 4 4 4 4 0 0
Not Completed 0 0 1 2 0 0 0 0 0 0
Reason Not Completed
Physician Decision             0             0             1             1             0             0             0             0             0             0
Withdrawal by Subject             0             0             0             1             0             0             0             0             0             0
Period Title: Part A, Period 3 (1 Day)
Started 3 4 4 2 4 4 4 4 0 0
Completed 3 4 4 2 4 4 4 4 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Part B (14 Days)
Started 0 0 0 0 0 0 0 0 3 9
Completed 0 0 0 0 0 0 0 0 3 9
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Part A:Placebo/200 µg GSK2292767/1000 µg GSK2292767 Part A:50 µg GSK2292767/Placebo/1000 µg GSK2292767 Part A:50 µg GSK2292767/200 µg GSK2292767/Placebo Part A:50 µg GSK2292767/200 µg GSK2292767/1000 µg GSK2292767 Part A:Placebo/500 µg GSK2292767/2000 µg GSK2292767 Part A:100 µg GSK2292767/Placebo/2000 µg GSK2292767 Part A:100 µg GSK2292767/500 µg GSK2292767/Placebo Part A:100 µg GSK2292767/500 µg GSK2292767/2000 µg GSK2292767 Part B: Placebo Part B: GSK2292767 2000 µg OD Total
Hide Arm/Group Description 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 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 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 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 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 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 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 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. Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI Total of all reporting groups
Overall Number of Baseline Participants 7 3 5 6 4 4 4 4 3 9 49
Hide Baseline Analysis Population Description
Data is presented for Part A and Part B. In Part B, 12 participants were included, 11 of them were taken from Part A and 1 additional participant only for Part B. Thus total number of participants included were 38 and not 49.
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 5 participants 6 participants 4 participants 4 participants 4 participants 4 participants 3 participants 9 participants 49 participants
<=18 years
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Between 18 and 65 years
7
 100.0%
2
  66.7%
5
 100.0%
6
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
3
 100.0%
9
 100.0%
48
  98.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: All enrolled participants have been confirmed by site to have been at least 18 years at the time of screening. One participants has a derived age of 17 due to the way in which their partial birthdate was imputed.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 5 participants 6 participants 4 participants 4 participants 4 participants 4 participants 3 participants 9 participants 49 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
3
 100.0%
5
 100.0%
6
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
3
 100.0%
9
 100.0%
49
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 5 participants 6 participants 4 participants 4 participants 4 participants 4 participants 3 participants 9 participants 49 participants
African American/African Heritage
2
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.1%
Asian - Central/South Asian Heritage
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
White
5
  71.4%
3
 100.0%
4
  80.0%
6
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
3
 100.0%
9
 100.0%
46
  93.9%
1.Primary Outcome
Title Part A: Number of Participants With Any Non-serious Adverse Event (nSAE) and Any Serious Adverse Event (SAE)
Hide Description 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.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised of all randomized participants who took at least 1 dose of study treatment.
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Measure Type: Count of Participants
Unit of Measure: Participants
nSAE
6
  26.1%
9
  75.0%
6
  50.0%
7
  53.8%
6
  50.0%
4
  44.4%
5
  41.7%
SAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Part B: Number of Participants With Any AE and Any SAE
Hide Description 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.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
nSAE
3
 100.0%
8
  88.9%
SAE
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description 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.
Time Frame Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
DBP, 30 min 0.3  (6.66) 2.0  (6.48) 2.4  (4.91) 2.0  (5.23) 2.5  (6.20) -1.6  (5.36) 1.9  (3.58)
DBP, 1 hour 0.8  (7.02) 3.1  (4.98) 3.8  (4.65) 1.2  (3.63) 4.1  (4.44) -0.9  (7.72) 0.8  (5.04)
DBP, 6 hour 0.1  (5.48) 0.3  (7.41) 1.8  (3.84) 1.9  (7.04) 3.2  (6.22) -2.0  (2.83) 3.1  (7.93)
DBP, 12 hour 2.3  (6.36) 3.1  (6.72) 2.9  (3.45) 4.0  (7.92) 2.3  (6.41) 0.7  (4.39) 3.1  (7.76)
DBP, 24 hour -1.3  (6.81) 0.6  (6.32) 1.5  (3.90) 3.6  (8.03) 3.6  (4.21) -2.9  (5.62) -0.1  (5.12)
SBP, 30 min -3.2  (6.28) -0.2  (5.06) -3.9  (9.67) 0.8  (5.16) -2.3  (6.20) -6.1  (4.73) -3.3  (5.85)
SBP, 1 hour -3.4  (7.72) -1.5  (4.74) -5.6  (8.07) -3.4  (7.01) -2.2  (6.53) -7.1  (9.06) -3.9  (8.38)
SBP, 6 hour 1.3  (8.79) 0.7  (8.23) -3.8  (9.03) 4.5  (7.92) 2.8  (6.34) -0.3  (7.48) -0.8  (5.86)
SBP, 12 hour 3.9  (6.65) 3.3  (6.52) -1.3  (8.65) 3.6  (4.93) 5.0  (9.53) 1.6  (4.03) 3.3  (7.33)
SBP, 24 hour -0.7  (6.19) -0.9  (7.54) -5.3  (5.26) 0.0  (8.67) -1.5  (6.78) -4.3  (5.74) -2.8  (5.77)
4.Primary Outcome
Title Part B: Change From Baseline in SBP and DBP
Hide Description 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.
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
DBP, Day 2, pre-dose -6.0  (10.15) -3.0  (4.72)
DBP, Day 3, pre-dose -8.3  (9.45) -1.3  (5.85)
DBP, Day 4, pre-dose -7.3  (12.10) -3.4  (4.90)
DBP, Day 5, pre-dose -10.7  (11.72) -2.2  (5.09)
DBP, Day 6, pre-dose -7.7  (10.02) -3.7  (4.72)
DBP, Day 7, pre-dose -8.3  (9.45) -2.3  (3.57)
DBP, Day 8, pre-dose -5.7  (12.42) -4.3  (3.91)
DBP, Day 9, pre-dose -6.3  (11.93) -2.8  (4.02)
DBP, Day 10, pre-dose -8.7  (11.93) -0.6  (6.21)
DBP, Day 11, pre-dose -9.3  (12.74) -2.1  (4.46)
DBP, Day 12, pre-dose -7.3  (7.51) -2.9  (4.23)
DBP, Day 13, pre-dose -7.0  (10.58) -3.0  (5.43)
DBP, Day 14, pre-dose -8.3  (10.97) -3.2  (3.83)
DBP, Day 14, 24 hours -1.3  (1.53) -1.0  (5.17)
SBP, Day 2, pre-dose 3.3  (11.24) -5.4  (7.60)
SBP, Day 3, pre-dose -0.7  (9.07) -0.1  (8.70)
SBP, Day 4, pre-dose 2.3  (10.50) -4.1  (7.75)
SBP, Day 5, pre-dose -1.0  (9.85) -5.1  (8.74)
SBP, Day 6, pre-dose -1.7  (8.50) -7.2  (7.26)
SBP, Day 7, pre-dose -4.7  (5.86) -5.0  (9.50)
SBP, Day 8, pre-dose -1.3  (8.08) -7.6  (10.01)
SBP, Day 9, pre-dose 0.0  (3.61) -5.8  (4.27)
SBP, Day 10, pre-dose -4.7  (5.13) -5.2  (6.65)
SBP, Day 11, pre-dose -6.3  (5.51) -4.4  (9.06)
SBP, Day 12, pre-dose -6.3  (4.73) -5.4  (6.54)
SBP, Day 13, pre-dose 2.3  (4.93) -4.9  (6.51)
SBP, Day 14, pre-dose -1.7  (7.57) -4.6  (7.33)
SBP, Day 14, 24 hours -0.7  (2.08) -3.7  (6.71)
5.Primary Outcome
Title Part A: Change From Baseline in Heart Rate
Hide Description 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.
Time Frame Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Mean (Standard Deviation)
Unit of Measure: Beats per minute
30 min -5.3  (5.39) -5.8  (5.40) -8.9  (8.46) -6.1  (5.25) -6.3  (5.37) -12.4  (6.80) -6.1  (7.24)
1 hour -8.0  (5.60) -4.8  (3.57) -9.0  (8.90) -7.2  (5.27) -4.3  (7.63) -13.0  (7.98) -9.8  (7.55)
6 hour 4.3  (9.45) 4.3  (5.58) 1.0  (9.55) 4.9  (5.42) 7.4  (6.37) -1.3  (7.42) 2.4  (7.98)
12 hour 4.2  (7.11) 6.4  (7.80) -0.3  (10.17) 3.7  (6.24) 3.7  (5.85) -1.8  (8.61) 5.3  (10.38)
24 hour -2.3  (6.24) -1.7  (6.69) -1.8  (8.70) -3.0  (7.23) -1.8  (8.02) -6.9  (5.88) -4.0  (8.18)
6.Primary Outcome
Title Part B: Change From Baseline in Heart Rate
Hide Description 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.
Time Frame 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 14
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Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 2, pre-dose -0.3  (6.11) -0.7  (7.14)
Day 3, pre-dose 3.0  (6.56) 0.0  (6.76)
Day 4, pre-dose 6.7  (11.50) -2.2  (8.03)
Day 5, pre-dose -2.3  (9.45) -3.2  (9.26)
Day 6, pre-dose -2.7  (8.14) -6.4  (7.80)
Day 7, pre-dose 3.7  (9.07) -0.8  (11.12)
Day 8, pre-dose 4.7  (13.50) -3.2  (5.85)
Day 9, pre-dose 1.7  (5.13) -3.4  (8.49)
Day 10, pre-dose 1.0  (11.79) -2.7  (10.28)
Day 11, pre-dose -1.3  (14.64) -2.8  (11.98)
Day 12, pre-dose -5.7  (7.23) -4.9  (6.47)
Day 13, pre-dose 4.0  (15.00) -4.4  (6.13)
Day 14, pre-dose 6.0  (11.27) -5.8  (9.36)
Day 14, 24 hours -2.3  (7.57) -2.2  (7.56)
7.Primary Outcome
Title Part A: Change From Baseline in Respiratory Rate
Hide Description 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.
Time Frame Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Median (Standard Deviation)
Unit of Measure: Breaths per minute
30 min -0.2  (1.78) -1.1  (2.81) -1.5  (1.98) 0.8  (2.48) 0.3  (2.01) 0.3  (2.74) -0.2  (1.95)
1 hour -0.3  (2.27) -1.0  (2.76) -1.2  (2.17) 0.8  (2.03) 0.6  (2.23) -0.3  (2.35) -0.8  (2.41)
6 hour 0.1  (2.18) 0.0  (3.67) 1.0  (1.95) 1.0  (2.97) 0.8  (3.33) 0.6  (2.74) 0.3  (2.23)
12 hour 0.7  (2.31) 0.7  (3.11) -0.4  (2.43) 1.3  (2.14) 0.6  (2.75) 0.3  (2.55) -0.3  (1.86)
24 hour -0.6  (2.29) -0.9  (3.20) -1.0  (2.63) 0.4  (2.50) -0.8  (2.08) -0.8  (3.15) -0.4  (1.68)
8.Primary Outcome
Title Part B: Change From Baseline in Respiratory Rate
Hide Description 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.
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
Day 2, pre-dose -2.3  (0.58) -0.6  (3.17)
Day 3, pre-dose -2.3  (2.31) -1.0  (3.20)
Day 4, pre-dose -2.3  (2.08) -0.3  (2.96)
Day 5, pre-dose -2.7  (2.31) -1.4  (2.65)
Day 6, pre-dose -2.7  (0.58) -1.6  (2.92)
Day 7, pre-dose -2.3  (2.31) -0.8  (2.59)
Day 8, pre-dose -2.7  (0.58) -0.7  (2.45)
Day 9, pre-dose -2.0  (2.00) 0.1  (2.98)
Day 10, pre-dose -1.7  (2.31) -1.2  (2.54)
Day 11, pre-dose -3.3  (0.58) -0.9  (3.62)
Day 12, pre-dose -2.3  (1.15) -1.0  (2.74)
Day 13, pre-dose -1.3  (1.15) -0.1  (3.06)
Day 14, pre-dose -2.0  (1.73) -1.1  (2.89)
Day 14, 24 hours -2.3  (1.53) -1.1  (2.26)
9.Primary Outcome
Title Part A: Change From Baseline in Tympanic Temperature
Hide Description 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.
Time Frame Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Mean (Standard Deviation)
Unit of Measure: Celsius
30 min 0.03  (0.313) 0.07  (0.210) 0.04  (0.574) 0.05  (0.395) -0.05  (0.366) 0.03  (0.287) 0.16  (0.385)
1 hour -0.10  (0.348) 0.06  (0.173) 0.05  (0.498) -0.06  (0.287) 0.05  (0.478) 0.12  (0.311) 0.10  (0.449)
6 hour 0.20  (0.390) 0.08  (0.259) 0.18  (0.566) 0.07  (0.446) 0.17  (0.409) 0.14  (0.361) 0.19  (0.493)
12 hour 0.14  (0.478) 0.31  (0.370) 0.27  (0.542) 0.26  (0.355) 0.20  (0.591) 0.46  (0.400) 0.18  (0.622)
24 hour -0.06  (0.375) -0.02  (0.233) -0.02  (0.513) 0.03  (0.287) 0.07  (0.392) 0.11  (0.326) 0.02  (0.497)
10.Primary Outcome
Title Part B: Change From Baseline in Tympanic Temperature
Hide Description 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.
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Mean (Standard Deviation)
Unit of Measure: Celsius
Day 2, pre-dose 0.17  (0.058) 0.26  (0.477)
Day 3, pre-dose 0.03  (0.379) 0.37  (0.450)
Day 4, pre-dose 0.13  (0.153) 0.26  (0.416)
Day 5, pre-dose 0.13  (0.404) 0.34  (0.445)
Day 6, pre-dose 0.10  (0.265) 0.31  (0.322)
Day 7, pre-dose -0.10  (0.100) 0.41  (0.448)
Day 8, pre-dose -0.27  (0.231) 0.29  (0.462)
Day 9, pre-dose -0.03  (0.153) 0.21  (0.326)
Day 10, pre-dose 0.13  (0.451) 0.31  (0.392)
Day 11, pre-dose 0.13  (0.306) 0.34  (0.343)
Day 12, pre-dose 0.00  (0.265) 0.32  (0.415)
Day 13, pre-dose 0.07  (0.513) 0.33  (0.466)
Day 14, pre-dose 0.17  (0.115) 0.32  (0.458)
Day 14, 24 hours 0.17  (0.115) 0.32  (0.502)
11.Primary Outcome
Title Part A: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Hide Description 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.
Time Frame Day 1 (pre-dose and 1 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Mean (Standard Deviation)
Unit of Measure: Liters
Pre-dose 4.389  (0.6781) 4.044  (0.6717) 4.768  (0.8348) 3.896  (0.7292) 4.288  (0.5288) 4.036  (0.4806) 4.391  (0.5072)
1 hour 4.347  (0.6781) 4.028  (0.7177) 4.461  (0.4693) 3.811  (0.6757) 4.223  (0.5153) 4.024  (0.5971) 4.435  (0.5851)
12.Primary Outcome
Title Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)
Hide Description 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.
Time Frame Up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Mean (Standard Deviation)
Unit of Measure: Liters
Day -1 4.333  (0.1739) 4.570  (0.6275)
Day 1,pre-dose 4.277  (0.0987) 4.408  (0.6852)
Day 1,1 hour 4.323  (0.0981) 4.413  (0.6931)
Day 2,pre-dose 4.357  (0.0551) 4.446  (0.7230)
Day 2,1 hour 4.373  (0.0569) 4.486  (0.6828)
Day 3,pre-dose 4.407  (0.1504) 4.474  (0.6999)
Day 3,1 hour 4.460  (0.2771) 4.493  (0.6548)
Day 4,pre-dose 4.447  (0.1159) 4.483  (0.7241)
Day 4,1 hour 4.307  (0.1060) 4.519  (0.7444)
Day 5,pre-dose 4.290  (0.1082) 4.494  (0.8042)
Day 5,1 hour 4.480  (0.2600) 4.486  (0.7647)
Day 6,pre-dose 4.300  (0.0173) 4.498  (0.7086)
Day 6,1 hour 4.533  (0.3177) 4.573  (0.7994)
Day 7,pre-dose 4.467  (0.2386) 4.503  (0.8559)
Day 7,1 hour 4.400  (0.2207) 4.581  (0.8018)
Day 8,pre-dose 4.383  (0.0351) 4.449  (0.7952)
Day 8,1 hour 4.440  (0.1229) 4.572  (0.6952)
Day 9,pre-dose 4.483  (0.2458) 4.512  (0.7483)
Day 9,1 hour 4.470  (0.1179) 4.627  (0.7737)
Day 10,pre-dose 4.443  (0.1419) 4.473  (0.6942)
Day 10,1 hour 4.583  (0.1914) 4.582  (0.7609)
Day 11,pre-dose 4.423  (0.1422) 4.570  (0.7944)
Day 11,1 hour 4.463  (0.2540) 4.609  (0.7460)
Day 12,pre-dose 4.417  (0.1258) 4.599  (0.7469)
Day 12,1 hour 4.440  (0.0917) 4.600  (0.7029)
Day 13,pre-dose 4.400  (0.2252) 4.514  (0.7352)
Day 13,1 hour 4.653  (0.2146) 4.768  (0.7609)
Day 14,pre-dose 4.533  (0.0666) 4.541  (0.8512)
Day 14,1 hour 4.557  (0.1701) 4.609  (0.8102)
13.Primary Outcome
Title Part A: Forced Vital Capacity (FVC)
Hide Description 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.
Time Frame Day 1 (pre-dose and 1 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Primary Outcome
Title Part B: Forced Vital Capacity (FVC)
Hide Description 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.
Time Frame Day 1 (pre-dose and 1 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Primary Outcome
Title Part A: Number of Participants With Electrocardiogram (ECG) Abnormalities
Hide Description 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.
Time Frame Day 1 of each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal - not clinically significant
2
   8.7%
2
  16.7%
1
   8.3%
0
   0.0%
1
   8.3%
0
   0.0%
1
   8.3%
Abnormal - clinically significant
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
16.Primary Outcome
Title Part B: Number of Participants With ECG Abnormalities
Hide Description 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.
Time Frame Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal - not clinically significant
1
  33.3%
2
  22.2%
Abnormal - clinically significant
0
   0.0%
0
   0.0%
17.Primary Outcome
Title Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)
Hide Description 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.
Time Frame 24 hours post-dose in each treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Measure Type: Count of Participants
Unit of Measure: Participants
Alkaline Phosphatase; to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Alanine Amino Transferase; to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
Aspartate Amino Transferase; to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin; to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium; to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium; to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose; to high
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose; to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium; to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; to high
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium; to low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18.Primary Outcome
Title Part B: Number of Participants With Clinical Chemistry Values of PCC
Hide Description 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)
Time Frame Pre-dose on Days 2, 4, 6, 8, 10, 12, and 14, 24 hours post-dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
Alkaline Phosphatase,Day 2;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alkaline Phosphatase,Day 4;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alkaline Phosphatase,Day 6;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alkaline Phosphatase,Day 8;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alkaline Phosphatase,Day 10;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alkaline Phosphatase,Day 12;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alkaline Phosphatase,Day 14,pre-dose;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alkaline Phosphatase,Day 14,24 hour;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 2;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 4;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 6;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 8;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 10;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 12;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 14,pre dose;to n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Alanine Amino Transferase,Day 14,24 hour;to hn=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 2;to high,n=3,8 Number Analyzed 3 participants 8 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 4;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 6;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 8;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 10;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 12;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 14,pre dose;n=2,9 Number Analyzed 2 participants 9 participants
0
   0.0%
0
   0.0%
Aspartate Amino Transferase,Day 14,24 hour,n=3,8 Number Analyzed 3 participants 8 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 2,;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 4;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 6;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 8;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 10;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 12;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 14,pre dose,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Total Bilirubin,Day 14,24 hours,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 2;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 2;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 4;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 4;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 6;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 6;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 8;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 8;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 10;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 10;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 12;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 12;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 14,pre dose,to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 14,pre dose,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 14,24 hour,to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Calcium,Day 14,24 hour,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 2;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 2;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 4;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 4;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 6;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 6;to low, n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 8;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 8;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 10;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 10;to low,,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 12;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 12;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 14;pre dose,to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 14;pre dose,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 14;24 hours,to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Glucose,Day 14;24 hours,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 2;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 2;to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 4;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 4,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 6;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 6,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 8;to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 8, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 10;to high,,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 10,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 12;to high,,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 12,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 14,pre dose,to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 14,pre dose,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 14,24 hour ,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Potassium,Day 14,24 hour,to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 2, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 2, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 4, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 4, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 6, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 6, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 8, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 8, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 10, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 10, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 12, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 12, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 14,pre dose, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 14,pre dose, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 14,24 hour, to high,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
Sodium,Day 14,24 hour, to low,n=3,9 Number Analyzed 3 participants 9 participants
0
   0.0%
0
   0.0%
19.Primary Outcome
Title Part A: Number of Participants With Hematology Values of PCC
Hide Description 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)
Time Frame 24 hours post-dose in each treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route.
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 23 12 12 13 12 9 12
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin; to high,n=23,12,12,13,12,9,12 Number Analyzed 23 participants 12 participants 12 participants 13 participants 12 participants 9 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hematocrit; to high,n=23,12,12,13,12,9,12 Number Analyzed 23 participants 12 participants 12 participants 13 participants 12 participants 9 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes; to low,n=23,12,12,13,12,9,12 Number Analyzed 23 participants 12 participants 12 participants 13 participants 12 participants 9 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Neutrophils; to low,n=23,12,12,13,12,9,12 Number Analyzed 23 participants 12 participants 12 participants 13 participants 12 participants 9 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count;to high;n=23, 12, 11, 13, 11, 9, 11 Number Analyzed 23 participants 12 participants 11 participants 13 participants 11 participants 9 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count; to low;n=23, 12, 11, 13, 11, 9, 11 Number Analyzed 23 participants 12 participants 11 participants 13 participants 11 participants 9 participants 11 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC count,to high,n=23, 12, 12, 13, 12, 9, 12 Number Analyzed 23 participants 12 participants 12 participants 13 participants 12 participants 9 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC count,to low,n=23, 12, 12, 13, 12, 9, 12 Number Analyzed 23 participants 12 participants 12 participants 13 participants 12 participants 9 participants 12 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
20.Primary Outcome
Title Part B: Number of Participants With Hematology Values of PCC
Hide Description 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
Time Frame Pre-dose on Days 2, 4, 6, 8, 10, 12, and 14, 24 hours post-dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Placebo 2000 µg OD
Hide Arm/Group Description:
Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
Hemoglobin,Day 2
0
   0.0%
0
   0.0%
Hemoglobin,Day 4
0
   0.0%
0
   0.0%
Hemoglobin,Day 6
0
   0.0%
0
   0.0%
Hemoglobin,Day 8
0
   0.0%
0
   0.0%
Hemoglobin,Day 10
0
   0.0%
0
   0.0%
Hemoglobin,Day 12
0
   0.0%
0
   0.0%
Hemoglobin,Day 14,pre dose
0
   0.0%
0
   0.0%
Hemoglobin,Day 14,24 hour
0
   0.0%
0
   0.0%
Hematocrit,Day 2
0
   0.0%
0
   0.0%
Hematocrit,Day 4
0
   0.0%
0
   0.0%
Hematocrit,Day 6
0
   0.0%
0
   0.0%
Hematocrit,Day 8
0
   0.0%
0
   0.0%
Hematocrit,Day 10
0
   0.0%
0
   0.0%
Hematocrit,Day 12
0
   0.0%
0
   0.0%
Hematocrit,Day 14,pre dose
0
   0.0%
0
   0.0%
Hematocrit,Day 14,24 hour
0
   0.0%
0
   0.0%
Lymphocytes,Day 2
0
   0.0%
0
   0.0%
Lymphocytes,Day 4
0
   0.0%
0
   0.0%
Lymphocytes,Day 6
0
   0.0%
0
   0.0%
Lymphocytes,Day 8
0
   0.0%
0
   0.0%
Lymphocytes,Day 10
0
   0.0%
0
   0.0%
Lymphocytes,Day 12
0
   0.0%
0
   0.0%
Lymphocytes,Day 14,pre dose
0
   0.0%
0
   0.0%
Lymphocytes,Day 14,24 hour
0
   0.0%
0
   0.0%
Total Neutrophils,Day 2
0
   0.0%
0
   0.0%
Total Neutrophils,Day 4
0
   0.0%
0
   0.0%
Total Neutrophils,Day 6
0
   0.0%
0
   0.0%
Total Neutrophils,Day 8
0
   0.0%
0
   0.0%
Total Neutrophils,Day 10
0
   0.0%
0
   0.0%
Total Neutrophils,Day 12
0
   0.0%
0
   0.0%
Total Neutrophils,Day 14,pre dose
0
   0.0%
0
   0.0%
Total Neutrophils,Day 14,24 hour
0
   0.0%
0
   0.0%
Platelet count,Day 2
0
   0.0%
0
   0.0%
Platelet count,Day 4
0
   0.0%
0
   0.0%
Platelet count,Day 6
0
   0.0%
0
   0.0%
Platelet count,Day 8
0
   0.0%
0
   0.0%
Platelet count,Day 10
0
   0.0%
0
   0.0%
Platelet count,Day 12
0
   0.0%
0
   0.0%
Platelet count,Day 14,pre dose
0
   0.0%
0
   0.0%
Platelet count,Day 14,24 hour
0
   0.0%
0
   0.0%
WBC count,Day 2
0
   0.0%
0
   0.0%
WBC count,Day 4
0
   0.0%
0
   0.0%
WBC count,Day 6
0
   0.0%
0
   0.0%
WBC count,Day 8
0
   0.0%
0
   0.0%
WBC count,Day 10
0
   0.0%
0
   0.0%
WBC count,Day 12
0
   0.0%
0
   0.0%
WBC count,Day 14,pre dose
0
   0.0%
0
   0.0%
WBC count,Day 14,24 hour
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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 periods
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 12 12 13 12 9 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*picograms per milliliter
AUC (0-24);n=0,2,5,10,8,11 Number Analyzed 0 participants 2 participants 5 participants 10 participants 8 participants 11 participants
596.1161
(10.0%)
721.9301
(57.9%)
2460.3695
(70.3%)
3689.7545
(36.0%)
7781.2593
(52.5%)
AUC(0-inf);n=0,2,5,7,6,10 Number Analyzed 0 participants 2 participants 5 participants 7 participants 6 participants 10 participants
596.4042
(10.1%)
724.6058
(57.8%)
2211.9120
(81.5%)
3709.6509
(40.6%)
8383.6427
(57.8%)
AUC (0-t);n=12,12,12,12,9,12 Number Analyzed 12 participants 12 participants 12 participants 12 participants 9 participants 12 participants
69.5822
(133.1%)
337.0775
(48.3%)
633.3267
(59.6%)
2164.3817
(72.3%)
3440.6354
(37.1%)
7758.9831
(50.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50 µg OD, 100 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.41
Confidence Interval (2-Sided) 90%
0.27 to 0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.243
Estimation Comments AUC(0-t). Standard error of mean was on logged scale
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 200 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 90%
0.65 to 1.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.243
Estimation Comments AUC(0-t).Standard error of mean was on logged scale
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 500 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.33
Confidence Interval (2-Sided) 90%
1.01 to 1.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.161
Estimation Comments AUC(0-t).Standard error of mean was on logged scale
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 1000 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 90%
0.69 to 1.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.255
Estimation Comments AUC(0-t).Standard error of mean was on logged scale
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 2000 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.25
Confidence Interval (2-Sided) 90%
0.95 to 1.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.161
Estimation Comments AUC(0-t).Standard error of mean was on logged scale
22.Secondary Outcome
Title Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767
Hide Description 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).
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population
Arm/Group Title 2000 µg OD
Hide Arm/Group Description:
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*picograms per milliliter
AUC (0-24); Day 1; n=8 Number Analyzed 8 participants
8163.4986
(71.7%)
AUC (0-24); Day 14; n=9 Number Analyzed 9 participants
9941.5681
(53.5%)
AUC(0-inf); Day 1; n=7 Number Analyzed 7 participants
10162.0636
(66.1%)
AUC(0-inf);Day 14; n=7 Number Analyzed 7 participants
13798.7637
(66.7%)
AUC (0-t); Day 1; n=9 Number Analyzed 9 participants
7506.5587
(72.3%)
AUC (0-t); Day 14; n=9 Number Analyzed 9 participants
11861.0783
(59.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2000 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.22
Confidence Interval (2-Sided) 90%
1.01 to 1.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.098
Estimation Comments Treatment ratio of adjusted geometric mean (Day 14/Day 1) for AUC(0-24) is presented
23.Secondary Outcome
Title Part A: Maximum Observed Plasma Drug Concentration (Cmax) of GSK2292767
Hide Description 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.
Time Frame 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 periods
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 12 12 12 12 9 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picograms per milliliter
36.9018
(31.9%)
90.8927
(30.6%)
170.7836
(43.7%)
356.0719
(39.4%)
579.8303
(39.5%)
1325.3877
(44.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 50 µg OD, 100 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio
Estimated Value 0.78
Confidence Interval (2-Sided) 90%
0.61 to 0.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.145
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 200 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.75 to 1.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.145
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 500 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio
Estimated Value 0.81
Confidence Interval (2-Sided) 90%
0.68 to 0.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.106
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 1000 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio
Estimated Value 0.66
Confidence Interval (2-Sided) 90%
0.51 to 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.154
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 100 µg OD, 2000 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio
Estimated Value 0.76
Confidence Interval (2-Sided) 90%
0.63 to 0.90
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.106
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Part B: Cmax of GSK2292767
Hide Description 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.
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 2000 µg OD
Hide Arm/Group Description:
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picograms per milliliter
Day 1
1145.7369
(45.9%)
Day 2
804.0363
(40.9%)
Day 3
871.6343
(38.0%)
Day 4
836.4375
(36.0%)
Day 5
764.7799
(35.5%)
Day 6
785.9632
(49.0%)
Day 7
877.1960
(37.7%)
Day 8
780.2829
(42.0%)
Day 9
745.6613
(35.2%)
Day 10
829.2395
(41.8%)
Day 11
952.5536
(40.1%)
Day 12
881.2328
(46.0%)
Day 13
888.9151
(42.9%)
Day 14
1305.8068
(41.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2000 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio
Estimated Value 1.14
Confidence Interval (2-Sided) 90%
0.96 to 1.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.104
Estimation Comments Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Cmax is presented
25.Secondary Outcome
Title Part A: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK2292767
Hide Description Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Tmax of GSK2292767 for part A is presented.
Time Frame 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 periods
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 12 12 12 12 9 12
Median (Full Range)
Unit of Measure: Hours
1.0046
(0.083 to 3.006)
0.7540
(0.086 to 4.002)
0.7500
(0.085 to 3.006)
0.7583
(0.085 to 4.001)
1.0264
(0.509 to 2.000)
1.0125
(0.502 to 3.010)
26.Secondary Outcome
Title Part B: Tmax of GSK2292767
Hide Description Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Tmax of GSK2292767 for part B is presented.
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 2000 µg OD
Hide Arm/Group Description:
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: Hours
Day 1
1.0056
(0.083 to 4.004)
Day 14
1.0050
(0.085 to 3.008)
27.Secondary Outcome
Title Part A: Terminal Half-life (T1/2) of GSK2292767
Hide Description 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.
Time Frame 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 periods
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 0 2 5 7 6 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
1.6658
(32.1%)
2.3157
(16.9%)
3.9789
(57.6%)
3.1712
(30.2%)
6.3179
(35.8%)
28.Secondary Outcome
Title Part B: T1/2 of GSK2292767
Hide Description 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.
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 2000 µg OD
Hide Arm/Group Description:
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours
Day 1
6.4625
(35.0%)
Day 14
11.7665
(48.6%)
29.Secondary Outcome
Title Part A: Trough Concentrations (Ctau) of GSK2292767
Hide Description 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.
Time Frame 24 hr post dose in each of the 3 treatment periods
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population
Arm/Group Title 50 µg OD 100 µg OD 200 µg OD 500 µg OD 1000 µg OD 2000 µg OD
Hide Arm/Group Description:
Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 0 0 0 6 3 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picograms per milliliter
43.5566
(65.9%)
44.1985
(46.4%)
71.6727
(55.6%)
30.Secondary Outcome
Title Part B: Ctau of GSK2292767
Hide Description 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).
Time Frame 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 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 2000 µg OD
Hide Arm/Group Description:
Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Pico grams per milliliter
Day 1;n=8 Number Analyzed 8 participants
78.4862
(91.4%)
Day 2;n=9 Number Analyzed 9 participants
103.4247
(83.8%)
Day 3;n=9 Number Analyzed 9 participants
98.3515
(84.1%)
Day 4;n=9 Number Analyzed 9 participants
112.5132
(83.4%)
Day 5;n=9 Number Analyzed 9 participants
98.4430
(87.6%)
Day 6;n=9 Number Analyzed 9 participants
106.6896
(96.2%)
Day 7;n=9 Number Analyzed 9 participants
101.1219
(88.3%)
Day 8;n=8 Number Analyzed 8 participants
116.9160
(62.4%)
Day 9;n=9 Number Analyzed 9 participants
105.3676
(81.7%)
Day 10;n=9 Number Analyzed 9 participants
117.8348
(80.5%)
Day 11;n=9 Number Analyzed 9 participants
112.3146
(66.4%)
Day 12;n=8 Number Analyzed 8 participants
129.6370
(62.8%)
Day 13;n=8 Number Analyzed 8 participants
154.5480
(52.6%)
Day 14;n=9 Number Analyzed 9 participants
138.2161
(96.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2000 µg OD
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 2.06
Confidence Interval (2-Sided) 90%
1.67 to 2.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.128
Estimation Comments Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Ctau is presented.
31.Secondary Outcome
Title Part B: Concentration of GSK2292767 in Bronchoalveolar Lavage (BAL)
Hide Description BAL samples were collected by bronchoscopy.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title 2000 µg OD
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Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picograms per milliliter
8852.94
(236.8%)
32.Secondary Outcome
Title Part B: Concentration of GSK2292767 in Lung Epithelial Lining Fluid (ELF)
Hide Description 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).
Time Frame Day 15
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Pharmacokinetic Population
Arm/Group Title 2000 µg OD
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Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
Overall Number of Participants Analyzed 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Picograms per milliliters
24 Hr Wash 1,n=0 Number Analyzed 0 participants
24 Hr Wash 2,n=8 Number Analyzed 8 participants
9777.25
(290.8%)
24 Hr Wash 3,n=7 Number Analyzed 7 participants
11921.13
(251.4%)
Time Frame nSAEs and SAEs were collected from start of study treatment up to 16 weeks
Adverse Event Reporting Description nSAEs and SAEs were collected in Safety Population
 
Arm/Group Title Part A: Placebo Part A: 50 µg OD Part A: 100 µg OD Part A: 200 µg OD Part A: 500 µg OD Part A: 1000 µg OD Part A: 2000 µg OD Part B: Placebo Part B: 2000ug OD
Hide Arm/Group Description Participants administered a single dose of placebo using ELLIPTA DPI via inhalation route. Participants administered a single dose of 50 µg GSK2292767 via inhalation route using ELLIPTA DPI Participants administered a single dose of 100 µg GSK2292767 via inhalation route using ELLIPTA DPI Participants administered a single dose of 200 µg GSK2292767 via inhalation route using ELLIPTA DPI Participants administered a single dose of 500 µg GSK2292767 via inhalation route using ELLIPTA DPI Participants administered a single dose of 1000 µg GSK2292767 via inhalation route using ELLIPTA DPI Participants administered a single dose of 2000 µg GSK2292767 via inhalation route using ELLIPTA DPI Participants were administered once daily dose of placebo for 14 days via inhalation route using ELLIPTA DPI Participants were administered 2000 µg GSK2292767 once daily for 14 days via inhalation route using ELLIPTA DPI
All-Cause Mortality
Part A: Placebo Part A: 50 µg OD Part A: 100 µg OD Part A: 200 µg OD Part A: 500 µg OD Part A: 1000 µg OD Part A: 2000 µg OD Part B: Placebo Part B: 2000ug OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/13 (0.00%)   0/12 (0.00%)   0/9 (0.00%)   0/12 (0.00%)   0/3 (0.00%)   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Part A: Placebo Part A: 50 µg OD Part A: 100 µg OD Part A: 200 µg OD Part A: 500 µg OD Part A: 1000 µg OD Part A: 2000 µg OD Part B: Placebo Part B: 2000ug OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/13 (0.00%)   0/12 (0.00%)   0/9 (0.00%)   0/12 (0.00%)   0/3 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: Placebo Part A: 50 µg OD Part A: 100 µg OD Part A: 200 µg OD Part A: 500 µg OD Part A: 1000 µg OD Part A: 2000 µg OD Part B: Placebo Part B: 2000ug OD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/23 (26.09%)   9/12 (75.00%)   6/12 (50.00%)   7/13 (53.85%)   6/12 (50.00%)   4/9 (44.44%)   5/12 (41.67%)   3/3 (100.00%)   8/9 (88.89%) 
Blood and lymphatic system disorders                   
Lymphadenopathy  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Cardiac disorders                   
Rhythm idioventricular  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Ear and labyrinth disorders                   
Ear disorder  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Ear pain  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Eye disorders                   
Visual impairment  1  0/23 (0.00%)  2/12 (16.67%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders                   
Gingival bleeding  1  0/23 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Lip ulceration  1  0/23 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Nausea  1  0/23 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Toothache  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/9 (0.00%) 
General disorders                   
Chest discomfort  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Chills  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Feeling cold  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Malaise  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Catheter site bruise  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Catheter site haematoma  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Chest pain  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Vessel puncture site bruise  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  3/9 (33.33%) 
Immune system disorders                   
Seasonal allergy  1  1/23 (4.35%)  0/12 (0.00%)  0/12 (0.00%)  1/13 (7.69%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Infections and infestations                   
Viral infection  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Viral upper respiratory tract infection  1  0/23 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  1/13 (7.69%)  2/12 (16.67%)  1/9 (11.11%)  0/12 (0.00%)  0/3 (0.00%)  0/9 (0.00%) 
Oropharyngeal candidiasis  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications                   
Contusion  1  0/23 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/13 (0.00%)  2/12 (16.67%)  0/9 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/9 (0.00%)