Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT02130635)

Results Overview

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalized ratio \>1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

From the start of study treatment until follow-up (assessed for approximately 19 days)

Results posted on

2018-10-11

Participant Flow

This study was comprised of two parts. In Part A, participants were randomized to active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses of active treatment in an equal ratio. Each part comprised a separate sample of participants.

Participant milestones

Participant milestones
Measure	Part A: Placebo Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: Placebo Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.	Part B: GSK2269577 100 µg Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A-Safety and Tolerability STARTED	7	21	0	0	0	0	0	0	0
Part A-Safety and Tolerability COMPLETED	7	21	0	0	0	0	0	0	0
Part A-Safety and Tolerability NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part B-Dose-Response Relationship STARTED	0	0	5	5	5	5	6	5	5
Part B-Dose-Response Relationship COMPLETED	0	0	5	5	5	5	6	5	5
Part B-Dose-Response Relationship NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

N=28

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: Placebo n=5 Participants Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.	Part B: GSK2269577 100 µg n=5 Participants Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.	Total n=64 Participants Total of all reporting groups
Age, Continuous	65.1 Years STANDARD_DEVIATION 5.81 • n=7 Participants • N=28	60.5 Years STANDARD_DEVIATION 6.68 • n=21 Participants • N=28	64.4 Years STANDARD_DEVIATION 4.45 • n=5 Participants • N=36	61.6 Years STANDARD_DEVIATION 4.56 • n=5 Participants • N=36	62.2 Years STANDARD_DEVIATION 8.23 • n=5 Participants • N=36	65.4 Years STANDARD_DEVIATION 5.81 • n=5 Participants • N=36	64.7 Years STANDARD_DEVIATION 7.26 • n=6 Participants • N=36	62.4 Years STANDARD_DEVIATION 9.24 • n=5 Participants • N=36	62.4 Years STANDARD_DEVIATION 6.43 • n=5 Participants • N=36	63.3 Years STANDARD_DEVIATION 6.34 • n=36 Participants • N=36
Sex: Female, Male Female	1 Participants n=7 Participants	7 Participants n=21 Participants	2 Participants n=5 Participants	4 Participants n=5 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants	3 Participants n=6 Participants	3 Participants n=5 Participants	3 Participants n=5 Participants	24 Participants n=64 Participants
Sex: Female, Male Male	6 Participants n=7 Participants	14 Participants n=21 Participants	3 Participants n=5 Participants	1 Participants n=5 Participants	4 Participants n=5 Participants	5 Participants n=5 Participants	3 Participants n=6 Participants	2 Participants n=5 Participants	2 Participants n=5 Participants	40 Participants n=64 Participants
Race/Ethnicity, Customized White-White/Caucasian/European Heritage	7 Participants n=7 Participants	21 Participants n=21 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	6 Participants n=6 Participants	5 Participants n=5 Participants	5 Participants n=5 Participants	64 Participants n=64 Participants

PRIMARY outcome

Timeframe: From the start of study treatment until follow-up (assessed for approximately 19 days)

Population: Safety Population: all participants who received at least one dose of study treatment.

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalized ratio \>1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event At least one AE	2 Participants	9 Participants	—	—	—	—	—
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event At least one SAE	0 Participants	1 Participants	—	—	—	—	—
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event At least one drug-related AE	2 Participants	6 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Total ANC; Day 14, 24 h post dose	-0.153 10^9 cells per liter (GI/L) Standard Deviation 0.887	-0.547 10^9 cells per liter (GI/L) Standard Deviation 0.977	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Lymphocytes; Day 7/Day 8, pre-dose	-0.033 10^9 cells per liter (GI/L) Standard Deviation 0.321	0.172 10^9 cells per liter (GI/L) Standard Deviation 0.597	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Monocytes; Day 7/Day 8, pre-dose	-0.036 10^9 cells per liter (GI/L) Standard Deviation 0.074	0.046 10^9 cells per liter (GI/L) Standard Deviation 0.149	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Monocytes; Day 14, 24 h post dose	0.039 10^9 cells per liter (GI/L) Standard Deviation 0.178	-0.022 10^9 cells per liter (GI/L) Standard Deviation 0.116	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Eosinophils; Day 7/Day 8, pre-dose	-0.006 10^9 cells per liter (GI/L) Standard Deviation 0.051	0.032 10^9 cells per liter (GI/L) Standard Deviation 0.074	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Lymphocytes; Day 14, 24 h post dose	-0.049 10^9 cells per liter (GI/L) Standard Deviation 0.197	0.030 10^9 cells per liter (GI/L) Standard Deviation 0.245	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points WBC; Day 7/Day 8, pre-dose	-0.736 10^9 cells per liter (GI/L) Standard Deviation 0.937	-0.080 10^9 cells per liter (GI/L) Standard Deviation 1.387	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points WBC; Day 14, 24 h post dose	-0.140 10^9 cells per liter (GI/L) Standard Deviation 1.220	-0.510 10^9 cells per liter (GI/L) Standard Deviation 0.947	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Total ANC; Day 7/Day 8, pre-dose	-0.664 10^9 cells per liter (GI/L) Standard Deviation 0.624	-0.363 10^9 cells per liter (GI/L) Standard Deviation 1.342	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Eosinophils; Day 14, 24 h post dose	0.001 10^9 cells per liter (GI/L) Standard Deviation 0.085	0.010 10^9 cells per liter (GI/L) Standard Deviation 0.075	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Basophils; Day 7/Day 8, pre-dose	-0.001 10^9 cells per liter (GI/L) Standard Deviation 0.006	0.006 10^9 cells per liter (GI/L) Standard Deviation 0.015	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Basophils; Day 14, 24 h post dose	-0.003 10^9 cells per liter (GI/L) Standard Deviation 0.013	0.002 10^9 cells per liter (GI/L) Standard Deviation 0.018	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Platelets; Day 7/Day 8, pre-dose	1.6 10^9 cells per liter (GI/L) Standard Deviation 20.58	17.9 10^9 cells per liter (GI/L) Standard Deviation 36.44	—	—	—	—	—
Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points Platelets; Day 14, 24 h post dose	14.7 10^9 cells per liter (GI/L) Standard Deviation 21.80	23.5 10^9 cells per liter (GI/L) Standard Deviation 37.43	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 h post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points Hemoglobin; Day 7/Day 8, pre-dose	-1.3 Grams/Liter (g/L) Standard Deviation 6.63	1.6 Grams/Liter (g/L) Standard Deviation 4.17	—	—	—	—	—
Part A: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points Hemoglobin; Day 14, 24 h post dose	0.3 Grams/Liter (g/L) Standard Deviation 6.97	1.0 Grams/Liter (g/L) Standard Deviation 4.12	—	—	—	—	—
Part A: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points MCHC; Day 7/Day 8, pre-dose	-5.3 Grams/Liter (g/L) Standard Deviation 7.32	-2.2 Grams/Liter (g/L) Standard Deviation 4.54	—	—	—	—	—
Part A: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points MCHC; Day 14, 24 h post dose	-8.4 Grams/Liter (g/L) Standard Deviation 4.39	-2.4 Grams/Liter (g/L) Standard Deviation 6.45	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Hematocrit at the Indicated Time Points Hematocrit; Day 7/Day 8, pre-dose	0.003 Ratio Standard Deviation 0.023	0.007 Ratio Standard Deviation 0.013	—	—	—	—	—
Part A: Change From Baseline in Hematocrit at the Indicated Time Points Hematocrit; Day 14, 24 h post dose	0.011 Ratio Standard Deviation 0.019	0.006 Ratio Standard Deviation 0.016	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points RBCs; Day 7/Day 8, pre-dose	0.023 10^12 cells/Liter (TI/L) Standard Deviation 0.230	0.060 10^12 cells/Liter (TI/L) Standard Deviation 0.141	—	—	—	—	—
Part A: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points RBCs; Day 14, 24 h post dose	0.119 10^12 cells/Liter (TI/L) Standard Deviation 0.201	0.063 10^12 cells/Liter (TI/L) Standard Deviation 0.160	—	—	—	—	—
Part A: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points Reticulocytes; Day 7/Day 8, pre-dose	0.005 10^12 cells/Liter (TI/L) Standard Deviation 0.014	0.003 10^12 cells/Liter (TI/L) Standard Deviation 0.009	—	—	—	—	—
Part A: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points Reticulocytes; Day 14, 24 h post dose	0.009 10^12 cells/Liter (TI/L) Standard Deviation 0.014	0.003 10^12 cells/Liter (TI/L) Standard Deviation 0.010	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points MCH; Day 7/Day 8, pre-dose	-0.46 Picograms (pg) Standard Deviation 0.602	-0.06 Picograms (pg) Standard Deviation 0.440	—	—	—	—	—
Part A: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points MCH; Day 14, 24 h post dose	-0.76 Picograms (pg) Standard Deviation 0.586	-0.23 Picograms (pg) Standard Deviation 0.593	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points MCV; Day 7/Day 8, pre-dose	0.11 Femtoliters (fL) Standard Deviation 0.687	0.43 Femtoliters (fL) Standard Deviation 0.697	—	—	—	—	—
Part A: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points MCV; Day 14, 24 h post dose	0.07 Femtoliters (fL) Standard Deviation 0.848	-0.03 Femtoliters (fL) Standard Deviation 1.193	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin; Day 7/Day 8, pre-dose	0.56 g/L Standard Deviation 2.230	0.80 g/L Standard Deviation 1.576	—	—	—	—	—
Part A: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin; Day 14, 24 h post doseTotal protein; Day	0.53 g/L Standard Deviation 2.379	0.52 g/L Standard Deviation 2.004	—	—	—	—	—
Part A: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein; Day 7/Day 8, pre-dose	0.56 g/L Standard Deviation 3.619	1.28 g/L Standard Deviation 2.599	—	—	—	—	—
Part A: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein; Day 14, 24 h post dose	0.84 g/L Standard Deviation 3.887	1.15 g/L Standard Deviation 2.606	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALT; Day 7/Day 8, pre-dose	2.46 International Units per Liter (IU/L) Standard Deviation 2.585	-0.61 International Units per Liter (IU/L) Standard Deviation 2.208	—	—	—	—	—
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALT; Day 14, 24 h post dose	1.51 International Units per Liter (IU/L) Standard Deviation 2.667	-0.40 International Units per Liter (IU/L) Standard Deviation 4.117	—	—	—	—	—
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALP; Day 7/Day 8, pre-dose	-0.64 International Units per Liter (IU/L) Standard Deviation 6.937	1.14 International Units per Liter (IU/L) Standard Deviation 8.586	—	—	—	—	—
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALP; Day 14, 24 h post dose	-2.23 International Units per Liter (IU/L) Standard Deviation 6.522	-0.21 International Units per Liter (IU/L) Standard Deviation 9.785	—	—	—	—	—
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points AST; Day 7/Day 8, pre-dose	3.14 International Units per Liter (IU/L) Standard Deviation 7.674	-1.03 International Units per Liter (IU/L) Standard Deviation 3.081	—	—	—	—	—
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points AST; Day 14, 24 h post dose	1.83 International Units per Liter (IU/L) Standard Deviation 4.750	-0.71 International Units per Liter (IU/L) Standard Deviation 2.592	—	—	—	—	—
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points GGT; Day 7/Day 8, pre-dose	-0.91 International Units per Liter (IU/L) Standard Deviation 2.203	0.11 International Units per Liter (IU/L) Standard Deviation 2.550	—	—	—	—	—
Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points GGT; Day 14, 24 h post dose	-1.96 International Units per Liter (IU/L) Standard Deviation 2.873	-0.46 International Units per Liter (IU/L) Standard Deviation 4.187	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Creatinine; Day 7/Day 8, pre-dose	2.31 Micromoles/Liter (micromol/L) Standard Deviation 4.385	-0.62 Micromoles/Liter (micromol/L) Standard Deviation 5.104	—	—	—	—	—
Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Creatinine; Day 14, 24 h post dose	3.64 Micromoles/Liter (micromol/L) Standard Deviation 6.035	0.07 Micromoles/Liter (micromol/L) Standard Deviation 3.259	—	—	—	—	—
Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Direct bilirubin; Day 7/Day 8, pre-dose	0.33 Micromoles/Liter (micromol/L) Standard Deviation 0.419	0.04 Micromoles/Liter (micromol/L) Standard Deviation 0.398	—	—	—	—	—
Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Direct bilirubin; Day 14, 24 h post dose	0.27 Micromoles/Liter (micromol/L) Standard Deviation 0.496	0.10 Micromoles/Liter (micromol/L) Standard Deviation 0.329	—	—	—	—	—
Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Total bilirubin; Day 7/Day 8, pre-dose	1.23 Micromoles/Liter (micromol/L) Standard Deviation 2.447	0.02 Micromoles/Liter (micromol/L) Standard Deviation 2.590	—	—	—	—	—
Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Total bilirubin; Day 14, 24 h post dose	0.90 Micromoles/Liter (micromol/L) Standard Deviation 2.805	0.78 Micromoles/Liter (micromol/L) Standard Deviation 1.720	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Calcium; Day 7/Day 8, pre-dose	0.033 Millimoles per Liter (mmol/L) Standard Deviation 0.0535	0.033 Millimoles per Liter (mmol/L) Standard Deviation 0.0617	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Calcium; Day 14, 24 h post dose	0.033 Millimoles per Liter (mmol/L) Standard Deviation 0.0850	0.029 Millimoles per Liter (mmol/L) Standard Deviation 0.0588	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Glucose; Day 7/Day 8, pre-dose	-0.053 Millimoles per Liter (mmol/L) Standard Deviation 0.3333	0.012 Millimoles per Liter (mmol/L) Standard Deviation 0.2888	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Glucose; Day 14, 24 h post dose	0.161 Millimoles per Liter (mmol/L) Standard Deviation 0.2659	0.024 Millimoles per Liter (mmol/L) Standard Deviation 0.4914	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Potassium; Day 7/Day 8, pre-dose	0.103 Millimoles per Liter (mmol/L) Standard Deviation 0.2279	0.011 Millimoles per Liter (mmol/L) Standard Deviation 0.3539	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Potassium; Day 14, 24 h post dose	0.161 Millimoles per Liter (mmol/L) Standard Deviation 0.2562	0.065 Millimoles per Liter (mmol/L) Standard Deviation 0.3347	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Sodium; Day 7/Day 8, pre-dose	1.21 Millimoles per Liter (mmol/L) Standard Deviation 2.800	0.88 Millimoles per Liter (mmol/L) Standard Deviation 1.560	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Sodium; Day 14, 24 h post dose	0.81 Millimoles per Liter (mmol/L) Standard Deviation 1.297	0.83 Millimoles per Liter (mmol/L) Standard Deviation 1.390	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points BUN; Day 7/Day 8, pre-dose	-0.530 Millimoles per Liter (mmol/L) Standard Deviation 1.0830	-0.192 Millimoles per Liter (mmol/L) Standard Deviation 0.8124	—	—	—	—	—
Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points BUN; Day 14, 24 h post dose	-0.464 Millimoles per Liter (mmol/L) Standard Deviation 1.1979	0.111 Millimoles per Liter (mmol/L) Standard Deviation 1.2147	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 7, and Day 14

Population: Safety Population

Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes \[min\] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). Potential clinical concern range for SBP was \<85 millimeters of mercury (mmHg) (low) and \>160 mmHg (high), for DBP \<45 mmHg (low) and \>100 mmHg (high) and for HR \<40 bpm and \>110 bpm. All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline SBP high	1 Participants	1 Participants	—	—	—	—	—
Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline SBP low	0 Participants	0 Participants	—	—	—	—	—
Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline DBP high	0 Participants	0 Participants	—	—	—	—	—
Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline DBP low	1 Participants	0 Participants	—	—	—	—	—
Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline HR high	0 Participants	1 Participants	—	—	—	—	—
Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline HR low	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 7, and Day 14

Population: Safety Population

Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Clinical significance was judged by the investigator. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline Normal	2 Participants	13 Participants	—	—	—	—	—
Part A: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline Abnormal - not clinically significant	5 Participants	8 Participants	—	—	—	—	—
Part A: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline Abnormal - clinically significant	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 1 (1 h post-dose), Day 7 (pre-dose and 1 h post-dose), and Day 14 (24 h post-dose)

Population: Safety Population

Baseline is Day 1 pre-dose. FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded. Baseline was the maximum of the planned pre-dose measurements on Day 1. Change from Baseline at any post-dose time point was calculated as the post-dose value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=7 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FEV1, Day 7/8, 1 h post dose	0.27 Liters Interval 0.15 to 0.39	0.18 Liters Interval 0.1 to 0.26	—	—	—	—	—
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FEV1, Day 1, 1 h post dose	0.15 Liters Interval -0.01 to 0.3	0.10 Liters Interval 0.02 to 0.18	—	—	—	—	—
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FEV1, Day 7/8, Pre-dose	0.03 Liters Interval -0.09 to 0.15	-0.04 Liters Interval -0.13 to 0.05	—	—	—	—	—
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FEV1, Day 14, 24 h post dose	-0.01 Liters Interval -0.09 to 0.06	0.01 Liters Interval -0.07 to 0.09	—	—	—	—	—
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FVC, Day 1, 1 h post dose	0.17 Liters Interval -0.13 to 0.47	0.16 Liters Interval 0.01 to 0.32	—	—	—	—	—
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FVC, Day 7/8, Predose	0.02 Liters Interval -0.23 to 0.26	0.00 Liters Interval -0.12 to 0.13	—	—	—	—	—
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FVC, Day 7/8, 1 h post dose	0.33 Liters Interval 0.09 to 0.58	0.22 Liters Interval 0.09 to 0.36	—	—	—	—	—
Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points FVC, Day 14, 24 h post dose	-0.04 Liters Interval -0.3 to 0.22	0.10 Liters Interval -0.07 to 0.27	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7 (pre-dose) and Day 14 (24 h post-dose)

Population: Safety Population

This outcome measure was used to estimate the inhibition levels of various doses of GSK2269557 by analyzing inflammatory cytokines IL6, IL8, and TNF alpha using Bayesian methods of statistical analysis, using non-informative prior distributions for all modeling parameters. Posterior medians (adjusted median response) and 95% credible intervals are reported here as medians and 95% confidence intervals respectively. 95% credible interval is reported as 2-sided 95% confidence in the statistical analyses. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14 IL6, Day 7/Day 8	41.30 Picograms/milliliter (pg/mL) Interval 22.07 to 78.24	37.40 Picograms/milliliter (pg/mL) Interval 19.64 to 70.65	28.23 Picograms/milliliter (pg/mL) Interval 14.8 to 53.18	30.82 Picograms/milliliter (pg/mL) Interval 16.23 to 58.0	52.23 Picograms/milliliter (pg/mL) Interval 28.73 to 94.94	31.25 Picograms/milliliter (pg/mL) Interval 16.01 to 63.01	33.40 Picograms/milliliter (pg/mL) Interval 17.52 to 63.23
Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14 IL6, Day 14	35.15 Picograms/milliliter (pg/mL) Interval 17.72 to 70.01	37.60 Picograms/milliliter (pg/mL) Interval 18.71 to 74.49	28.27 Picograms/milliliter (pg/mL) Interval 14.1 to 56.22	22.68 Picograms/milliliter (pg/mL) Interval 11.32 to 45.13	35.19 Picograms/milliliter (pg/mL) Interval 18.32 to 66.93	42.56 Picograms/milliliter (pg/mL) Interval 20.57 to 90.25	41.52 Picograms/milliliter (pg/mL) Interval 20.62 to 82.81
Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14 IL8, Day 7/Day 8	2633.21 Picograms/milliliter (pg/mL) Interval 1401.19 to 4879.27	2118.15 Picograms/milliliter (pg/mL) Interval 1157.33 to 3866.74	1860.78 Picograms/milliliter (pg/mL) Interval 995.35 to 3499.61	1523.63 Picograms/milliliter (pg/mL) Interval 834.99 to 2745.9	2650.13 Picograms/milliliter (pg/mL) Interval 1535.07 to 4634.07	2636.08 Picograms/milliliter (pg/mL) Interval 1412.65 to 4978.59	2279.48 Picograms/milliliter (pg/mL) Interval 1205.35 to 4210.75
Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14 IL8, Day 14	2942.28 Picograms/milliliter (pg/mL) Interval 1375.08 to 6216.67	2664.75 Picograms/milliliter (pg/mL) Interval 1269.52 to 5544.49	1879.92 Picograms/milliliter (pg/mL) Interval 876.5 to 4056.53	1619.12 Picograms/milliliter (pg/mL) Interval 778.39 to 3309.81	1356.35 Picograms/milliliter (pg/mL) Interval 696.37 to 2645.82	2394.65 Picograms/milliliter (pg/mL) Interval 1125.17 to 5196.2	2170.41 Picograms/milliliter (pg/mL) Interval 1010.85 to 4582.03
Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14 TNFalpha, Day 7/Day 8	3.35 Picograms/milliliter (pg/mL) Interval 1.22 to 8.98	1.55 Picograms/milliliter (pg/mL) Interval 0.57 to 4.33	1.16 Picograms/milliliter (pg/mL) Interval 0.42 to 3.25	1.54 Picograms/milliliter (pg/mL) Interval 0.57 to 4.19	7.32 Picograms/milliliter (pg/mL) Interval 3.02 to 17.85	3.68 Picograms/milliliter (pg/mL) Interval 1.26 to 10.51	2.62 Picograms/milliliter (pg/mL) Interval 0.94 to 7.15
Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14 TNFalpha, Day 14	2.91 Picograms/milliliter (pg/mL) Interval 1.26 to 6.54	3.02 Picograms/milliliter (pg/mL) Interval 1.33 to 7.0	1.25 Picograms/milliliter (pg/mL) Interval 0.55 to 2.9	1.26 Picograms/milliliter (pg/mL) Interval 0.55 to 2.87	3.99 Picograms/milliliter (pg/mL) Interval 1.86 to 8.5	3.00 Picograms/milliliter (pg/mL) Interval 1.34 to 6.75	1.53 Picograms/milliliter (pg/mL) Interval 0.66 to 3.47

SECONDARY outcome

Timeframe: Day 1 (Pre-dose, 5 min, 30 min, 1, 2, 4 & 6 hours post-dose)

Population: PK Population: participants in the Safety Population for whom a PK sample was obtained and analyzed.

A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Only those participants who were available at the indicated time points were analyzed (represented by n=X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=21 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose Pre-dose; n=0	NA pg/mL A value of NA indicates that the geometric mean or 95% confidence interval is not available.	—	—	—	—	—	—
Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 5 min; n=21	386.2 pg/mL Interval 287.5 to 518.7	—	—	—	—	—	—
Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 30 min; n=21	337.2 pg/mL Interval 274.6 to 414.0	—	—	—	—	—	—
Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 1 h; n=21	379.1 pg/mL Interval 320.2 to 448.9	—	—	—	—	—	—
Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 2 h; n=21	531.1 pg/mL Interval 448.2 to 629.4	—	—	—	—	—	—
Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 4 h; n=21	419.5 pg/mL Interval 357.6 to 492.1	—	—	—	—	—	—
Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 6 h; n=21	334.4 pg/mL Interval 287.0 to 389.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, and 6 h post-dose on Day 1

Population: PK Population

A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Concentration measurements were log-transformed. Only those participants who were available at the indicated time points were analyzed (represented by n=X,X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=6 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=5 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose Pre-dose; n=0,0,0,0,0,0	NA pg/mL A value of NA indicates that the geometric mean or 95% confidence interval is not available.	NA pg/mL A value of NA indicates that the geometric mean or 95% confidence interval is not available.	NA pg/mL A value of NA indicates that the geometric mean or 95% confidence interval is not available.	NA pg/mL A value of NA indicates that the geometric mean or 95% confidence interval is not available.	NA pg/mL A value of NA indicates that the geometric mean or 95% confidence interval is not available.	NA pg/mL A value of NA indicates that the geometric mean or 95% confidence interval is not available.	—
Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 5 min; n=5,5,5,6,5,5	55.3 pg/mL Interval 33.7 to 90.7	80.4 pg/mL Interval 38.4 to 168.2	173.1 pg/mL Interval 88.4 to 339.0	466.6 pg/mL Interval 147.3 to 1478.0	853.4 pg/mL Interval 380.2 to 1915.6	982.9 pg/mL Interval 311.1 to 3105.3	—
Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 30 min; n=5,5,5,6,5,5	51.7 pg/mL Interval 36.2 to 74.1	73.8 pg/mL Interval 41.6 to 130.8	203 pg/mL Interval 111.2 to 370.5	402.3 pg/mL Interval 218.0 to 742.5	556.9 pg/mL Interval 384.8 to 806.0	1011.6 pg/mL Interval 757.1 to 1351.6	—
Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 1 h; n=5,5,5,6,5,5	61.3 pg/mL Interval 45.7 to 82.3	77.2 pg/mL Interval 44.1 to 135.2	253.2 pg/mL Interval 155.0 to 413.8	429.1 pg/mL Interval 294.2 to 626.0	599.7 pg/mL Interval 370.5 to 970.7	1203.3 pg/mL Interval 799.1 to 1812.0	—
Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 2 h; n=5,5,5,6,5,5	60.6 pg/mL Interval 44.8 to 81.9	88.8 pg/mL Interval 60.2 to 130.9	300.9 pg/mL Interval 173.7 to 521.1	556.7 pg/mL Interval 372.4 to 832.3	672.3 pg/mL Interval 434.0 to 1041.5	1402 pg/mL Interval 892.8 to 2201.4	—
Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 4 h; n=5,5,5,6,5,5	45.0 pg/mL Interval 33.1 to 61.2	73.4 pg/mL Interval 60.5 to 89.1	251 pg/mL Interval 146.0 to 431.6	391.6 pg/mL Interval 303.3 to 505.5	468.7 pg/mL Interval 305.5 to 719.2	1098.5 pg/mL Interval 781.9 to 1543.2	—
Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose 6 h; n=5,5,5,6,5,5	38.3 pg/mL Interval 29.7 to 49.5	63.8 pg/mL Interval 50.7 to 80.3	201.5 pg/mL Interval 128.3 to 316.6	294.6 pg/mL Interval 222.3 to 390.4	466.5 pg/mL Interval 273.1 to 796.6	900.8 pg/mL Interval 723.8 to 1121.0	—

SECONDARY outcome

Timeframe: Day 7 immediately after dosing

Population: PK Population

Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Day 7 sampling could be done on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=21 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7	1109.1 pg/mL Interval 901.5 to 1364.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 7 immediately after dosing

Population: PK Population

Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Concentration values were log-transformed. Day 7 sampling could be done on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=6 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=5 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7	109.6 pg/mL Interval 62.6 to 191.8	203.4 pg/mL Interval 140.3 to 294.8	511.8 pg/mL Interval 233.2 to 1123.3	1022.2 pg/mL Interval 623.7 to 1675.2	1655.1 pg/mL Interval 803.2 to 3410.4	2923.4 pg/mL Interval 1769.4 to 4830.0	—

SECONDARY outcome

Timeframe: Day 7 and Day 15

Population: PK Population

Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=21 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part A: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15 Day 7/Day 8	604.1 pg/mL Interval 496.6 to 735.0	—	—	—	—	—	—
Part A: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15 Day 15	711.2 pg/mL Interval 561.8 to 900.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 7 and Day 15

Population: PK Population

Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=6 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=5 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15 Day 7/Day 8	55.3 pg/mL Interval 41.22 to 74.21	119.17 pg/mL Interval 78.47 to 180.97	314.38 pg/mL Interval 182.64 to 541.16	588.09 pg/mL Interval 486.63 to 710.69	724.33 pg/mL Interval 581.37 to 902.45	1468.94 pg/mL Interval 1000.5 to 2156.7	—
Part B: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15 Day 15	74.93 pg/mL Interval 48.26 to 116.33	128.71 pg/mL Interval 92.02 to 180.03	237.36 pg/mL Interval 66.38 to 848.74	665.9 pg/mL Interval 497.61 to 891.1	1218.5 pg/mL Interval 985.88 to 1506.01	1767.34 pg/mL Interval 1079.72 to 2892.86	—

SECONDARY outcome

Timeframe: Day 1 to Day 15

Population: Safety Population

Rescue medication was identified from concomitant medication records and the patient diaries which were provided to the participants to record data throughout the treatment period. Only participants who used rescue medication were analyzed. The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=3 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=1 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=1 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=1 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=3 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=1 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Number of Times Rescue Medication Was Used by Participants Daily, During the Treatment Period	2.00 Number of times Standard Deviation 0.00	2.3 Number of times Standard Deviation NA The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.	2.2 Number of times Standard Deviation NA The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.	—	1.0 Number of times Standard Deviation NA The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.	1.4 Number of times Standard Deviation 0.63	1.0 Number of times Standard Deviation NA The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.

SECONDARY outcome

Timeframe: From the start of study treatment until follow-up (assessed for approximately 19 days)

Population: Safety Population

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase \>=3 x upper limit of normal (ULN), and total bilirubin \>=2 x ULN or international normalized ratio \>1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event At least one AE	3 Participants	3 Participants	2 Participants	1 Participants	3 Participants	4 Participants	2 Participants
Part B: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event At least one SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event At least one drug-related AE	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Monocytes; Day 14, 24 h post dose	-0.022 10^9 cells per liter (GI/L) Standard Deviation 0.0676	-0.012 10^9 cells per liter (GI/L) Standard Deviation 0.0926	-0.036 10^9 cells per liter (GI/L) Standard Deviation 0.0829	-0.004 10^9 cells per liter (GI/L) Standard Deviation 0.1313	0.03 10^9 cells per liter (GI/L) Standard Deviation 0.0699	0.108 10^9 cells per liter (GI/L) Standard Deviation 0.3437	-0.11 10^9 cells per liter (GI/L) Standard Deviation 0.0834
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Platelets; Day 7/Day 8, pre-dose	-13.8 10^9 cells per liter (GI/L) Standard Deviation 14.22	-0.8 10^9 cells per liter (GI/L) Standard Deviation 18.07	10 10^9 cells per liter (GI/L) Standard Deviation 24.52	15.6 10^9 cells per liter (GI/L) Standard Deviation 17.78	11.7 10^9 cells per liter (GI/L) Standard Deviation 15.41	26.5 10^9 cells per liter (GI/L) Standard Deviation 32.77	-0.6 10^9 cells per liter (GI/L) Standard Deviation 14.4
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Basophils; Day 7/Day 8, pre-dose	0.014 10^9 cells per liter (GI/L) Standard Deviation 0.0241	-0.002 10^9 cells per liter (GI/L) Standard Deviation 0.0228	0.01 10^9 cells per liter (GI/L) Standard Deviation 0.0187	0.004 10^9 cells per liter (GI/L) Standard Deviation 0.0182	0.007 10^9 cells per liter (GI/L) Standard Deviation 0.0052	-0.005 10^9 cells per liter (GI/L) Standard Deviation 0.01	0 10^9 cells per liter (GI/L) Standard Deviation 0.01
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Basophils; Day 14, 24 h post dose	0.004 10^9 cells per liter (GI/L) Standard Deviation 0.0167	-0.006 10^9 cells per liter (GI/L) Standard Deviation 0.0261	0.01 10^9 cells per liter (GI/L) Standard Deviation 0.0122	-0.002 10^9 cells per liter (GI/L) Standard Deviation 0.0192	0.007 10^9 cells per liter (GI/L) Standard Deviation 0.0175	-0.008 10^9 cells per liter (GI/L) Standard Deviation 0.0189	0.01 10^9 cells per liter (GI/L) Standard Deviation 0.0122
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Eosinophils; Day 7/Day 8, pre-dose	-0.002 10^9 cells per liter (GI/L) Standard Deviation 0.0576	0.01 10^9 cells per liter (GI/L) Standard Deviation 0.0485	-0.034 10^9 cells per liter (GI/L) Standard Deviation 0.0702	-0.026 10^9 cells per liter (GI/L) Standard Deviation 0.0498	0.022 10^9 cells per liter (GI/L) Standard Deviation 0.1289	-0.002 10^9 cells per liter (GI/L) Standard Deviation 0.0287	0.012 10^9 cells per liter (GI/L) Standard Deviation 0.0438
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Eosinophils; Day 14, 24 h post dose	0.046 10^9 cells per liter (GI/L) Standard Deviation 0.0472	-0.01 10^9 cells per liter (GI/L) Standard Deviation 0.0292	-0.046 10^9 cells per liter (GI/L) Standard Deviation 0.0378	-0.054 10^9 cells per liter (GI/L) Standard Deviation 0.1498	0.025 10^9 cells per liter (GI/L) Standard Deviation 0.1078	0.023 10^9 cells per liter (GI/L) Standard Deviation 0.0222	0.022 10^9 cells per liter (GI/L) Standard Deviation 0.0396
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Lymphocytes; Day 7/Day 8, pre-dose	0.242 10^9 cells per liter (GI/L) Standard Deviation 0.4797	-0.178 10^9 cells per liter (GI/L) Standard Deviation 0.5657	-0.022 10^9 cells per liter (GI/L) Standard Deviation 0.1326	-0.094 10^9 cells per liter (GI/L) Standard Deviation 0.3092	0.093 10^9 cells per liter (GI/L) Standard Deviation 0.2813	-0.118 10^9 cells per liter (GI/L) Standard Deviation 0.3223	-0.218 10^9 cells per liter (GI/L) Standard Deviation 0.6236
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Lymphocytes; Day 14, 24 h post dose	-0.09 10^9 cells per liter (GI/L) Standard Deviation 0.4499	-0.264 10^9 cells per liter (GI/L) Standard Deviation 0.3134	-0.216 10^9 cells per liter (GI/L) Standard Deviation 0.208	0.092 10^9 cells per liter (GI/L) Standard Deviation 0.9722	0.21 10^9 cells per liter (GI/L) Standard Deviation 0.3855	-0.243 10^9 cells per liter (GI/L) Standard Deviation 0.3054	-0.398 10^9 cells per liter (GI/L) Standard Deviation 0.736
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Monocytes; Day 7/Day 8, pre-dose	-0.062 10^9 cells per liter (GI/L) Standard Deviation 0.0867	0.05 10^9 cells per liter (GI/L) Standard Deviation 0.0941	-0.02 10^9 cells per liter (GI/L) Standard Deviation 0.0806	0.05 10^9 cells per liter (GI/L) Standard Deviation 0.2108	0.018 10^9 cells per liter (GI/L) Standard Deviation 0.1209	0.165 10^9 cells per liter (GI/L) Standard Deviation 0.5166	-0.08 10^9 cells per liter (GI/L) Standard Deviation 0.1398
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Platelets; Day 14, 24 h post dose	-3.3 10^9 cells per liter (GI/L) Standard Deviation 22.25	-13 10^9 cells per liter (GI/L) Standard Deviation 26.52	-7.2 10^9 cells per liter (GI/L) Standard Deviation 20.41	-1.4 10^9 cells per liter (GI/L) Standard Deviation 44.86	7 10^9 cells per liter (GI/L) Standard Deviation 19.81	-8.3 10^9 cells per liter (GI/L) Standard Deviation 51.57	-11.4 10^9 cells per liter (GI/L) Standard Deviation 29.39
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points WBC; Day 7/Day 8, pre-dose	0.372 10^9 cells per liter (GI/L) Standard Deviation 1.5852	-0.024 10^9 cells per liter (GI/L) Standard Deviation 1.1519	0.102 10^9 cells per liter (GI/L) Standard Deviation 1.1107	0.926 10^9 cells per liter (GI/L) Standard Deviation 3.1314	0.497 10^9 cells per liter (GI/L) Standard Deviation 0.8673	0.5 10^9 cells per liter (GI/L) Standard Deviation 2.676	-0.802 10^9 cells per liter (GI/L) Standard Deviation 0.7889
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points WBC; Day 14, 24 h post dose	-0.49 10^9 cells per liter (GI/L) Standard Deviation 0.5204	-0.864 10^9 cells per liter (GI/L) Standard Deviation 1.4151	-0.164 10^9 cells per liter (GI/L) Standard Deviation 0.7907	-0.178 10^9 cells per liter (GI/L) Standard Deviation 2.2899	0.648 10^9 cells per liter (GI/L) Standard Deviation 1.143	0.825 10^9 cells per liter (GI/L) Standard Deviation 1.6016	-1.012 10^9 cells per liter (GI/L) Standard Deviation 1.3388
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Total ANC; Day 7/Day 8, pre-dose	0.164 10^9 cells per liter (GI/L) Standard Deviation 0.9782	0.09 10^9 cells per liter (GI/L) Standard Deviation 0.6553	0.17 10^9 cells per liter (GI/L) Standard Deviation 1.0481	1.018 10^9 cells per liter (GI/L) Standard Deviation 2.6669	0.335 10^9 cells per liter (GI/L) Standard Deviation 0.5921	0.448 10^9 cells per liter (GI/L) Standard Deviation 2.153	-0.51 10^9 cells per liter (GI/L) Standard Deviation 0.285
Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points Total ANC; Day 14, 24 h post dose	-0.44 10^9 cells per liter (GI/L) Standard Deviation 0.4288	-0.538 10^9 cells per liter (GI/L) Standard Deviation 1.1027	0.134 10^9 cells per liter (GI/L) Standard Deviation 0.801	-0.18 10^9 cells per liter (GI/L) Standard Deviation 1.469	0.385 10^9 cells per liter (GI/L) Standard Deviation 1.2151	0.958 10^9 cells per liter (GI/L) Standard Deviation 1.8925	-0.51 10^9 cells per liter (GI/L) Standard Deviation 0.7931

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points Hemoglobin; Day 7/Day 8, pre-dose	3 g/L Standard Deviation 2.55 • Interval 2.55 to	0.8 g/L Standard Deviation 5.76	3.8 g/L Standard Deviation 6.76	1 g/L Standard Deviation 4.74	0.3 g/L Standard Deviation 5.65	6 g/L Standard Deviation 5.89	1 g/L Standard Deviation 3.39
Part B: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points Hemoglobin; Day 14, 24 h post dose	4.2 g/L Standard Deviation 6.14 • Interval 6.14 to	-1.2 g/L Standard Deviation 6.14	-0.6 g/L Standard Deviation 8.02	-2 g/L Standard Deviation 6.86	-2.2 g/L Standard Deviation 2.14	-0.3 g/L Standard Deviation 4.65	-0.2 g/L Standard Deviation 4.44
Part B: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points MCHC; Day 7/Day 8, pre-dose	-2.4 g/L Standard Deviation 2.07 • Interval 2.07 to	-0.6 g/L Standard Deviation 8.17	-4.0 g/L Standard Deviation 7.31	-4.4 g/L Standard Deviation 9.61	0.5 g/L Standard Deviation 5.17	3.3 g/L Standard Deviation 8.18	7.8 g/L Standard Deviation 10.85
Part B: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points MCHC; Day 14, 24 h post dose	3.8 g/L Standard Deviation 5.07 • Interval 5.07 to	-2.6 g/L Standard Deviation 3.51	-4.4 g/L Standard Deviation 8.73	3.0 g/L Standard Deviation 4.00	2.5 g/L Standard Deviation 3.83	-8.5 g/L Standard Deviation 7.59	1.6 g/L Standard Deviation 11.76

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=4 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points RBC; Day 7/Day 8, pre-dose	0.076 10^12 cells/Liter (TI/L) Standard Deviation 0.1148	0.036 10^12 cells/Liter (TI/L) Standard Deviation 0.1549	0.18 10^12 cells/Liter (TI/L) Standard Deviation 0.2703	0.058 10^12 cells/Liter (TI/L) Standard Deviation 0.1314	-0.023 10^12 cells/Liter (TI/L) Standard Deviation 0.1508	0.14 10^12 cells/Liter (TI/L) Standard Deviation 0.0879	-0.058 10^12 cells/Liter (TI/L) Standard Deviation 0.1252
Part B: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points RBC; Day 14, 24 h post dose	0.11 10^12 cells/Liter (TI/L) Standard Deviation 0.1891	-0.038 10^12 cells/Liter (TI/L) Standard Deviation 0.1663	0.034 10^12 cells/Liter (TI/L) Standard Deviation 0.1785	-0.07 10^12 cells/Liter (TI/L) Standard Deviation 0.1815	-0.083 10^12 cells/Liter (TI/L) Standard Deviation 0.0958	0.042 10^12 cells/Liter (TI/L) Standard Deviation 0.1031	-0.084 10^12 cells/Liter (TI/L) Standard Deviation 0.1496
Part B: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points Reticulocytes; Day 7/Day 8, pre-dose	-0.00064 10^12 cells/Liter (TI/L) Standard Deviation 0.01328	0.00714 10^12 cells/Liter (TI/L) Standard Deviation 0.020838	0.01298 10^12 cells/Liter (TI/L) Standard Deviation 0.011129	0.01258 10^12 cells/Liter (TI/L) Standard Deviation 0.014565	0.00397 10^12 cells/Liter (TI/L) Standard Deviation 0.008856	0.00882 10^12 cells/Liter (TI/L) Standard Deviation 0.018576	0.01792 10^12 cells/Liter (TI/L) Standard Deviation 0.012824
Part B: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points Reticulocytes; Day 14, 24 h post dose	0.0034 10^12 cells/Liter (TI/L) Standard Deviation 0.014934	0.0006 10^12 cells/Liter (TI/L) Standard Deviation 0.010183	0.01032 10^12 cells/Liter (TI/L) Standard Deviation 0.015404	0.0156 10^12 cells/Liter (TI/L) Standard Deviation 0.013092	-0.00172 10^12 cells/Liter (TI/L) Standard Deviation 0.005382	-0.01063 10^12 cells/Liter (TI/L) Standard Deviation 0.018329	0.00884 10^12 cells/Liter (TI/L) Standard Deviation 0.015546

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Hematocrit at the Indicated Time Points Day 7/Day 8, pre-dose	0.012 Ratio Standard Deviation 0.0084	0.004 Ratio Standard Deviation 0.0182	0.018 Ratio Standard Deviation 0.0259	0.01 Ratio Standard Deviation 0.01	0 Ratio Standard Deviation 0.0141	0.015 Ratio Standard Deviation 0.0058	-0.010 Ratio Standard Deviation 0.0235
Part B: Change From Baseline in Hematocrit at the Indicated Time Points Day 14, 24 h post dose	0.008 Ratio Standard Deviation 0.0217	0 Ratio Standard Deviation 0.0212	0.006 Ratio Standard Deviation 0.0152	-0.012 Ratio Standard Deviation 0.0217	-0.01 Ratio Standard Deviation 0.0063	0.01 Ratio Standard Deviation 0.0082	-0.004 Ratio Standard Deviation 0.0207

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=4 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points Day 7/Day 8, pre-dose	0.18 pg Standard Deviation 0.415	-0.06 pg Standard Deviation 0.397	-0.36 pg Standard Deviation 0.351	-0.08 pg Standard Deviation 0.669	0.2 pg Standard Deviation 0.529	0.35 pg Standard Deviation 0.961	0.58 pg Standard Deviation 0.46
Part B: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points Day 14, 24 h post dose	0.18 pg Standard Deviation 0.626	0.02 pg Standard Deviation 0.259	-0.34 pg Standard Deviation 0.74	0.12 pg Standard Deviation 0.396	0.1 pg Standard Deviation 0.363	-0.33 pg Standard Deviation 0.754	0.52 pg Standard Deviation 0.268

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=4 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points MCV; Day 14, 24 h post dose	-0.66 fL Standard Deviation 1.537	0.80 fL Standard Deviation 1.257	0.26 fL Standard Deviation 1.935	-0.62 fL Standard Deviation 1.281	-0.53 fL Standard Deviation 1.601	1.53 fL Standard Deviation 0.699	0.98 fL Standard Deviation 3.155
Part B: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points MCV; Day 7/Day 8, pre-dose	1.24 fL Standard Deviation 0.706	-0.14 fL Standard Deviation 1.794	-0.12 fL Standard Deviation 1.708	0.88 fL Standard Deviation 1.085	0.42 fL Standard Deviation 2.302	0.20 fL Standard Deviation 0.583	-0.70 fL Standard Deviation 2.719

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin; Day 7/Day 8, pre-dose	0.96 g/L Standard Deviation 1.773	1.22 g/L Standard Deviation 1.571	0.96 g/L Standard Deviation 3.012	0.88 g/L Standard Deviation 0.887	-0.6 g/L Standard Deviation 1.814	1.18 g/L Standard Deviation 1.069	0.3 g/L Standard Deviation 1.49
Part B: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Albumin; Day 14, 24 h post dose	0.9 g/L Standard Deviation 2.965	0.7 g/L Standard Deviation 2.134	-0.12 g/L Standard Deviation 2.538	-1.16 g/L Standard Deviation 2.157	-1.13 g/L Standard Deviation 1.365	0.44 g/L Standard Deviation 1.001	0.26 g/L Standard Deviation 1.187
Part B: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein; Day 7/Day 8, pre-dose	1.34 g/L Standard Deviation 2.46	0.72 g/L Standard Deviation 1.203	2.22 g/L Standard Deviation 4.953	0.98 g/L Standard Deviation 2.039	-1.4 g/L Standard Deviation 2.662	1.78 g/L Standard Deviation 2.338	1.12 g/L Standard Deviation 1.571
Part B: Change From Baseline in Albumin and Total Protein at the Indicated Time Points Total protein; Day 14, 24 h post dose	0.96 g/L Standard Deviation 3.392	0.96 g/L Standard Deviation 2.393	-0.16 g/L Standard Deviation 3.737	-1.96 g/L Standard Deviation 3.635	-2.13 g/L Standard Deviation 2.156	0.72 g/L Standard Deviation 1.154	0.7 g/L Standard Deviation 2.277

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALP; Day 7/Day 8, pre-dose	1.88 International Units per Liter (IU/L) Standard Deviation 5.45	1.62 International Units per Liter (IU/L) Standard Deviation 5.756	1.64 International Units per Liter (IU/L) Standard Deviation 7.946	5.7 International Units per Liter (IU/L) Standard Deviation 9.986	-0.95 International Units per Liter (IU/L) Standard Deviation 7.807	-0.92 International Units per Liter (IU/L) Standard Deviation 22.572	1.66 International Units per Liter (IU/L) Standard Deviation 5.465
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALP; Day 14, 24 h post dose	1.54 International Units per Liter (IU/L) Standard Deviation 4.503	4.78 International Units per Liter (IU/L) Standard Deviation 7.294	-0.2 International Units per Liter (IU/L) Standard Deviation 6.109	0.26 International Units per Liter (IU/L) Standard Deviation 9.829	-1.1 International Units per Liter (IU/L) Standard Deviation 8.535	-5.34 International Units per Liter (IU/L) Standard Deviation 19.016	5.2 International Units per Liter (IU/L) Standard Deviation 4.038
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALT; Day 7/Day 8, pre-dose	1.58 International Units per Liter (IU/L) Standard Deviation 2.24	3.66 International Units per Liter (IU/L) Standard Deviation 6.057	-2.44 International Units per Liter (IU/L) Standard Deviation 7.23	2.6 International Units per Liter (IU/L) Standard Deviation 4.994	-0.1 International Units per Liter (IU/L) Standard Deviation 2.994	-2.4 International Units per Liter (IU/L) Standard Deviation 5.036	1.42 International Units per Liter (IU/L) Standard Deviation 2.791
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points ALT; Day 14, 24 h post dose	0.36 International Units per Liter (IU/L) Standard Deviation 2.268	2.18 International Units per Liter (IU/L) Standard Deviation 3.17	-2.76 International Units per Liter (IU/L) Standard Deviation 6.176	0.84 International Units per Liter (IU/L) Standard Deviation 5.223	-0.72 International Units per Liter (IU/L) Standard Deviation 4.63	-2.86 International Units per Liter (IU/L) Standard Deviation 5.478	1.58 International Units per Liter (IU/L) Standard Deviation 3.754
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points AST; Day 7/Day 8, pre-dose	1.38 International Units per Liter (IU/L) Standard Deviation 2.464	3.76 International Units per Liter (IU/L) Standard Deviation 11.142	-0.42 International Units per Liter (IU/L) Standard Deviation 3.13	0.26 International Units per Liter (IU/L) Standard Deviation 5.185	-0.22 International Units per Liter (IU/L) Standard Deviation 3.672	-2.56 International Units per Liter (IU/L) Standard Deviation 5.607	3.04 International Units per Liter (IU/L) Standard Deviation 2.048
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points AST; Day 14, 24 h post dose	0.44 International Units per Liter (IU/L) Standard Deviation 1.691	0.16 International Units per Liter (IU/L) Standard Deviation 1.673	-2.44 International Units per Liter (IU/L) Standard Deviation 3.443	-1.64 International Units per Liter (IU/L) Standard Deviation 6.027	0.02 International Units per Liter (IU/L) Standard Deviation 3.129	-1.66 International Units per Liter (IU/L) Standard Deviation 4.536	2.66 International Units per Liter (IU/L) Standard Deviation 1.25
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points GGT; Day 7/Day 8, pre-dose	-0.6 International Units per Liter (IU/L) Standard Deviation 2.119	-0.3 International Units per Liter (IU/L) Standard Deviation 1.856	-0.96 International Units per Liter (IU/L) Standard Deviation 4.556	-0.3 International Units per Liter (IU/L) Standard Deviation 4.471	1.88 International Units per Liter (IU/L) Standard Deviation 4.747	-3.18 International Units per Liter (IU/L) Standard Deviation 9.7	0.74 International Units per Liter (IU/L) Standard Deviation 1.141
Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points GGT; Day 14, 24 h post dose	-0.64 International Units per Liter (IU/L) Standard Deviation 0.934	0.1 International Units per Liter (IU/L) Standard Deviation 2.625	-2.64 International Units per Liter (IU/L) Standard Deviation 6.532	-0.72 International Units per Liter (IU/L) Standard Deviation 5.485	1.52 International Units per Liter (IU/L) Standard Deviation 5.783	-6.16 International Units per Liter (IU/L) Standard Deviation 17.113	0.54 International Units per Liter (IU/L) Standard Deviation 1.923

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Direct bilirubin; Day 7/Day 8, pre-dose	-0.02 Micromoles/Liter (micromol/L) Standard Deviation 0.327	0.24 Micromoles/Liter (micromol/L) Standard Deviation 0.493	-0.28 Micromoles/Liter (micromol/L) Standard Deviation 0.881	0.16 Micromoles/Liter (micromol/L) Standard Deviation 0.261	0.23 Micromoles/Liter (micromol/L) Standard Deviation 0.65	-0.18 Micromoles/Liter (micromol/L) Standard Deviation 1.36	-0.32 Micromoles/Liter (micromol/L) Standard Deviation 0.37
Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Direct bilirubin; Day 14, 24 h post dose	-0.1 Micromoles/Liter (micromol/L) Standard Deviation 0.453	-0.02 Micromoles/Liter (micromol/L) Standard Deviation 0.192	-0.58 Micromoles/Liter (micromol/L) Standard Deviation 0.581	0.22 Micromoles/Liter (micromol/L) Standard Deviation 0.409	0.2 Micromoles/Liter (micromol/L) Standard Deviation 0.429	0.02 Micromoles/Liter (micromol/L) Standard Deviation 0.554	-0.14 Micromoles/Liter (micromol/L) Standard Deviation 0.456
Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Total bilirubin; Day 7/Day 8, pre-dose	0.28 Micromoles/Liter (micromol/L) Standard Deviation 2.255	0.56 Micromoles/Liter (micromol/L) Standard Deviation 2.151	-0.7 Micromoles/Liter (micromol/L) Standard Deviation 4.049	0.72 Micromoles/Liter (micromol/L) Standard Deviation 2.196	1.08 Micromoles/Liter (micromol/L) Standard Deviation 2.775	-0.86 Micromoles/Liter (micromol/L) Standard Deviation 1.75	-1.5 Micromoles/Liter (micromol/L) Standard Deviation 1.739
Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Total bilirubin; Day 14, 24 h post dose	-0.5 Micromoles/Liter (micromol/L) Standard Deviation 3.389	0.08 Micromoles/Liter (micromol/L) Standard Deviation 0.87	-2.08 Micromoles/Liter (micromol/L) Standard Deviation 2.387	0.52 Micromoles/Liter (micromol/L) Standard Deviation 2.7	1.22 Micromoles/Liter (micromol/L) Standard Deviation 3.008	0.5 Micromoles/Liter (micromol/L) Standard Deviation 2.804	-1.06 Micromoles/Liter (micromol/L) Standard Deviation 1.479
Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Creatinine; Day 7/Day 8, pre-dose	4.52 Micromoles/Liter (micromol/L) Standard Deviation 4.533	1.6 Micromoles/Liter (micromol/L) Standard Deviation 3.77	4.38 Micromoles/Liter (micromol/L) Standard Deviation 2.217	-0.3 Micromoles/Liter (micromol/L) Standard Deviation 4.567	0.52 Micromoles/Liter (micromol/L) Standard Deviation 4.397	3.48 Micromoles/Liter (micromol/L) Standard Deviation 3.084	0.76 Micromoles/Liter (micromol/L) Standard Deviation 5.421
Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points Creatinine; Day 14, 24 h post dose	1.58 Micromoles/Liter (micromol/L) Standard Deviation 7.276	0.76 Micromoles/Liter (micromol/L) Standard Deviation 3.319	4.84 Micromoles/Liter (micromol/L) Standard Deviation 4.636	-0.46 Micromoles/Liter (micromol/L) Standard Deviation 6.98	2.05 Micromoles/Liter (micromol/L) Standard Deviation 3.17	1.36 Micromoles/Liter (micromol/L) Standard Deviation 2.545	1.42 Micromoles/Liter (micromol/L) Standard Deviation 5.058

SECONDARY outcome

Timeframe: Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)

Population: Safety Population

Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Calcium; Day 14, 24 h post dose	0.024 Millimoles per Liter (mmol/L) Standard Deviation 0.0865	-0.012 Millimoles per Liter (mmol/L) Standard Deviation 0.0482	0.05 Millimoles per Liter (mmol/L) Standard Deviation 0.0696	-0.01 Millimoles per Liter (mmol/L) Standard Deviation 0.0758	-0.042 Millimoles per Liter (mmol/L) Standard Deviation 0.0422	0.03 Millimoles per Liter (mmol/L) Standard Deviation 0.0292	0.036 Millimoles per Liter (mmol/L) Standard Deviation 0.0568
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Calcium; Day 7/Day 8, pre-dose	0.048 Millimoles per Liter (mmol/L) Standard Deviation 0.0444	0.044 Millimoles per Liter (mmol/L) Standard Deviation 0.0397	0.06 Millimoles per Liter (mmol/L) Standard Deviation 0.0579	0.01 Millimoles per Liter (mmol/L) Standard Deviation 0.0648	-0.008 Millimoles per Liter (mmol/L) Standard Deviation 0.0655	0.066 Millimoles per Liter (mmol/L) Standard Deviation 0.0811	0.044 Millimoles per Liter (mmol/L) Standard Deviation 0.0365
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Glucose; Day 7/Day 8, pre-dose	-0.06 Millimoles per Liter (mmol/L) Standard Deviation 0.2939	0.054 Millimoles per Liter (mmol/L) Standard Deviation 0.4057	0.05 Millimoles per Liter (mmol/L) Standard Deviation 0.1937	-0.43 Millimoles per Liter (mmol/L) Standard Deviation 1.4084	-0.11 Millimoles per Liter (mmol/L) Standard Deviation 0.5658	0.11 Millimoles per Liter (mmol/L) Standard Deviation 0.4369	-0.246 Millimoles per Liter (mmol/L) Standard Deviation 0.273
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Glucose; Day 14, 24 h post dose	-0.086 Millimoles per Liter (mmol/L) Standard Deviation 0.3743	-0.142 Millimoles per Liter (mmol/L) Standard Deviation 0.3746	0.26 Millimoles per Liter (mmol/L) Standard Deviation 0.5456	0.054 Millimoles per Liter (mmol/L) Standard Deviation 0.2294	-0.34 Millimoles per Liter (mmol/L) Standard Deviation 0.7332	-0.076 Millimoles per Liter (mmol/L) Standard Deviation 0.3518	-0.314 Millimoles per Liter (mmol/L) Standard Deviation 0.3871
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Potassium; Day 7/Day 8, pre-dose	0.246 Millimoles per Liter (mmol/L) Standard Deviation 0.3088	0.09 Millimoles per Liter (mmol/L) Standard Deviation 0.2793	0.434 Millimoles per Liter (mmol/L) Standard Deviation 0.5451	-0.204 Millimoles per Liter (mmol/L) Standard Deviation 0.2563	0.135 Millimoles per Liter (mmol/L) Standard Deviation 0.3172	0.276 Millimoles per Liter (mmol/L) Standard Deviation 0.3566	0.192 Millimoles per Liter (mmol/L) Standard Deviation 0.4587
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Potassium; Day 14, 24 h post dose	0.19 Millimoles per Liter (mmol/L) Standard Deviation 0.1944	0.12 Millimoles per Liter (mmol/L) Standard Deviation 0.4282	0.336 Millimoles per Liter (mmol/L) Standard Deviation 0.5268	-0.128 Millimoles per Liter (mmol/L) Standard Deviation 0.3241	0.013 Millimoles per Liter (mmol/L) Standard Deviation 0.203	0.14 Millimoles per Liter (mmol/L) Standard Deviation 0.1259	0.072 Millimoles per Liter (mmol/L) Standard Deviation 0.5946
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Sodium; Day 7/Day 8, pre-dose	0 Millimoles per Liter (mmol/L) Standard Deviation 1.206	0.6 Millimoles per Liter (mmol/L) Standard Deviation 1.626	-0.12 Millimoles per Liter (mmol/L) Standard Deviation 1.714	1.18 Millimoles per Liter (mmol/L) Standard Deviation 1.139	-0.33 Millimoles per Liter (mmol/L) Standard Deviation 2.072	0.7 Millimoles per Liter (mmol/L) Standard Deviation 1.815	-0.84 Millimoles per Liter (mmol/L) Standard Deviation 2.137
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Sodium; Day 14, 24 h post dose	-0.16 Millimoles per Liter (mmol/L) Standard Deviation 1.301	-0.04 Millimoles per Liter (mmol/L) Standard Deviation 3.233	0.58 Millimoles per Liter (mmol/L) Standard Deviation 1.399	0.46 Millimoles per Liter (mmol/L) Standard Deviation 1.447	-0.18 Millimoles per Liter (mmol/L) Standard Deviation 2.515	1.06 Millimoles per Liter (mmol/L) Standard Deviation 1.074	-0.4 Millimoles per Liter (mmol/L) Standard Deviation 2.72
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Urea/BUN; Day 7/Day 8, pre-dose	0.314 Millimoles per Liter (mmol/L) Standard Deviation 0.7077	-0.504 Millimoles per Liter (mmol/L) Standard Deviation 0.6955	0.342 Millimoles per Liter (mmol/L) Standard Deviation 0.8193	-0.91 Millimoles per Liter (mmol/L) Standard Deviation 1.0653	-0.29 Millimoles per Liter (mmol/L) Standard Deviation 0.4396	-0.244 Millimoles per Liter (mmol/L) Standard Deviation 1.2909	0.162 Millimoles per Liter (mmol/L) Standard Deviation 1.2285
Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points Urea/BUN; Day 14, 24 h post dose	-0.232 Millimoles per Liter (mmol/L) Standard Deviation 0.3592	-0.124 Millimoles per Liter (mmol/L) Standard Deviation 0.7502	0.142 Millimoles per Liter (mmol/L) Standard Deviation 1.0269	-0.906 Millimoles per Liter (mmol/L) Standard Deviation 1.6431	-0.335 Millimoles per Liter (mmol/L) Standard Deviation 0.2793	-0.364 Millimoles per Liter (mmol/L) Standard Deviation 0.8554	0.186 Millimoles per Liter (mmol/L) Standard Deviation 2.0478

SECONDARY outcome

Timeframe: Day 1, Day 7, and Day 14

Population: Safety Population

Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes \[min\] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline SBP high	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline SBP low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline DBP high	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline DBP low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline HR high	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline HR low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1, Day 7, and Day 14

Population: Safety Population

Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Day 7 assessments could be conducted on Day 7 or Day 8.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline Normal	4 Participants	5 Participants	3 Participants	2 Participants	5 Participants	5 Participants	4 Participants
Part B: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline Abnormal - not clinically significant	1 Participants	0 Participants	2 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Part B: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline Abnormal - clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Screening (up to 30 days prior to Day 1) and Follow-up (approximately Day 19)

Population: Safety Population

FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded.

Outcome measures

Outcome measures
Measure	Part A: Placebo n=5 Participants Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: GSK2269577 200 µg n=5 Participants Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 Participants Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 Participants Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 Participants Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 Participants Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Part B: Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Screening and Follow-up FVC, Follow-up	2.96 Liters Interval 2.432 to 3.488	3.042 Liters Interval 1.809 to 4.275	3.764 Liters Interval 2.533 to 4.995	4.192 Liters Interval 3.527 to 4.857	3.137 Liters Interval 2.057 to 4.217	3.03 Liters Interval 1.691 to 4.369	3.192 Liters Interval 1.968 to 4.416
Part B: Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Screening and Follow-up FEV1, Screening	1.586 Liters Interval 1.093 to 2.079	1.387 Liters Interval 0.783 to 1.99	1.533 Liters Interval 0.784 to 2.282	1.558 Liters Interval 0.916 to 2.199	1.573 Liters Interval 1.092 to 2.055	1.36 Liters Interval 1.126 to 1.594	1.407 Liters Interval 0.768 to 2.046
Part B: Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Screening and Follow-up FEV1, Follow-up	1.494 Liters Interval 1.174 to 1.813	1.272 Liters Interval 0.69 to 1.855	1.523 Liters Interval 0.775 to 2.271	1.34 Liters Interval 1.092 to 1.589	1.501 Liters Interval 0.989 to 2.013	1.405 Liters Interval 0.948 to 1.861	1.431 Liters Interval 0.834 to 2.028
Part B: Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Screening and Follow-up FVC, Screening	3.05 Liters Interval 2.476 to 3.624	3.08 Liters Interval 1.901 to 4.259	3.632 Liters Interval 2.585 to 4.679	4.348 Liters Interval 3.565 to 5.131	3.277 Liters Interval 2.389 to 4.164	2.958 Liters Interval 1.6 to 4.316	3.156 Liters Interval 2.099 to 4.213

Adverse Events

Part A: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: GSK2269577 1000 µg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: GSK2269577 100 µg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: GSK2269577 200 µg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B: GSK2269577 500 µg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: GSK2269577 700 µg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: GSK2269577 1000 µg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B: GSK2269577 2000 µg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Placebo n=7 participants at risk Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 participants at risk Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: Placebo n=5 participants at risk Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.	Part B: GSK2269577 100 µg n=5 participants at risk Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 200 µg n=5 participants at risk Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 participants at risk Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 participants at risk Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 participants at risk Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 participants at risk Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Cardiac disorders Atrial fibrillation	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	4.8% 1/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.

Other adverse events

Other adverse events
Measure	Part A: Placebo n=7 participants at risk Participants received 2 inhalations of matching placebo once daily for 14 consecutive days.	Part A: GSK2269577 1000 µg n=21 participants at risk Participants received repeat doses of GSK2269557 1000 micrograms (µg) (2 inhalations of 500 µg each from a single device) administered as a dry powder inhalation, once daily for 14 consecutive days.	Part B: Placebo n=5 participants at risk Participants received four inhalations of matching placebo (from four inhalation devices) once daily for 14 consecutive days.	Part B: GSK2269577 100 µg n=5 participants at risk Participants received repeat doses of GSK2269557 100 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 200 µg n=5 participants at risk Participants received repeat doses of GSK2269557 200 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 100 µg or placebo.	Part B: GSK2269577 500 µg n=5 participants at risk Participants received repeat doses of GSK2269557 500 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 700 µg n=6 participants at risk Participants received repeat doses of GSK2269557 700 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 100 µg, 500 µg, or placebo.	Part B: GSK2269577 1000 µg n=5 participants at risk Participants received repeat doses of GSK2269557 1000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing either GSK2269557 500 µg or placebo.	Part B: GSK2269577 2000 µg n=5 participants at risk Participants received repeat doses of GSK2269557 2000 µg administered as a dry powder inhalation, once daily for 14 consecutive days. To maintain blinding, the total dose was delivered through four inhalation devices, each device containing GSK2269557 500 µg.
Gastrointestinal disorders Diarrhoea	14.3% 1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	14.3% 1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	14.3% 1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	4.8% 1/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Infections and infestations Oral herpes	14.3% 1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	9.5% 2/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Headache	14.3% 1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	14.3% 3/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	19.0% 4/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	50.0% 3/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	80.0% 4/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	40.0% 2/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Eye disorders Lacrimation increased	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Gastrointestinal disorders Toothache	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
General disorders Catheter site haematoma	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
General disorders Vessel puncture site inflammation	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Infections and infestations Rhinitis	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Infections and infestations Sinusitis	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	16.7% 1/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Psychiatric disorders Sleep disorder	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/7 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/21 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	20.0% 1/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/6 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.	0.00% 0/5 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs), defined as those events occurring from the start of treatment until follow-up (up to approximately 19 days), are reported. SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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