Trial Outcomes & Findings for An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis (NCT NCT03557281)

NCT ID: NCT03557281

Last Updated: 2023-10-26

Results Overview

The Early Bactericidal Activity was determined by change in log10CFU/mL of sputum over the period Baseline to Day 14. Log(CFU) was calculated as: Log(CFU/mL)=log10(mean\[Total count 1:Total Count 2\]\*2\*5\*10\^Dilution); where total counts 1 and 2 were bacterial counts from plates 1 and 2 respectively; \*2 represents the 1:1 dilution of the original specimen and \*5 represents the 0.2 mL (200 microliter) inoculation of the specimen; Dilution is the dilution factor for that plate. Baseline (Day 0) was defined as the mean of Day -2 and Day -1; if data was available at only one of these timepoints then that value was used as Baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: Baseline and up to Day 14
• Results posted on: 2023-10-26

Participant Flow

This was an open-label trial to investigate the early bactericidal activity, safety and tolerability of GSK3036656 in participants with drug-sensitive pulmonary tuberculosis. Participants received Rifafour e-275 as a standard-of-care or GSK3036656. Rifafour e-275 is a registered trademark of Sanofi-Aventis company.

A total of 76 participants were enrolled (Enrolled Population consisted of all participants who passed screening and entered the study) in this study.

Participant milestones

Measure	Rifafour e-275 All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Overall Study STARTED	18	9	17	16	16
Overall Study Safety Population Consisted of All Randomized Participants Who Received at Least 1 Dose of Treatment	18	9	17	16	15
Overall Study COMPLETED	18	8	15	15	13
Overall Study NOT COMPLETED	0	1	2	1	3

Reasons for withdrawal

Measure	Rifafour e-275 All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Overall Study Investigator discretion	0	0	1	0	0
Overall Study Withdrawal by Subject	0	1	1	1	2
Overall Study Randomized, but did not receive treatment	0	0	0	0	1

Baseline Characteristics

An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis

Baseline characteristics by cohort

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.	Total n=75 Participants Total of all reporting groups
Age, Continuous	37.0 Years STANDARD_DEVIATION 10.20 • n=93 Participants	37.8 Years STANDARD_DEVIATION 8.38 • n=4 Participants	38.1 Years STANDARD_DEVIATION 10.33 • n=27 Participants	39.8 Years STANDARD_DEVIATION 12.33 • n=483 Participants	38.5 Years STANDARD_DEVIATION 9.82 • n=36 Participants	38.2 Years STANDARD_DEVIATION 10.22 • n=10 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants	16 Participants n=483 Participants	15 Participants n=36 Participants	75 Participants n=10 Participants
Race/Ethnicity, Customized Black or African American	18 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants	16 Participants n=483 Participants	15 Participants n=36 Participants	75 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and up to Day 14

Population: Efficacy Population consisted of participants in the safety population who provided at least two evaluable overnight sputum samples.

The Early Bactericidal Activity was determined by change in log10CFU/mL of sputum over the period Baseline to Day 14. Log(CFU) was calculated as: Log(CFU/mL)=log10(mean[Total count 1:Total Count 2]*2*5*10^Dilution); where total counts 1 and 2 were bacterial counts from plates 1 and 2 respectively; *2 represents the 1:1 dilution of the original specimen and *5 represents the 0.2 mL (200 microliter) inoculation of the specimen; Dilution is the dilution factor for that plate. Baseline (Day 0) was defined as the mean of Day -2 and Day -1; if data was available at only one of these timepoints then that value was used as Baseline.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change in log10 Colony Forming Units (CFU) Per (/) Milliliter (mL) of Direct Respiratory Sputum Samples From Baseline to Day 14	-0.199 Log10CFU/mL Standard Error 0.0130	-0.017 Log10CFU/mL Standard Error 0.0182	-0.092 Log10CFU/mL Standard Error 0.0136	-0.092 Log10CFU/mL Standard Error 0.0142	-0.138 Log10CFU/mL Standard Error 0.0147

SECONDARY outcome

Timeframe: Baseline and up to Day 2

Population: Efficacy Population consisted of participants in the safety population who provided at least two evaluable overnight sputum samples. Only those participants with data available at specified time points were analyzed.

The Early Bactericidal Activity was determined by change in log10CFU per mL of sputum over the period Baseline to Day 2. Log(CFU) was calculated as: Log(CFU/mL)=log10(mean[Total count 1:Total Count 2]*2*5*10^Dilution); where total counts 1 and 2 were bacterial counts from plates 1 and 2 respectively; *2 represents the 1:1 dilution of the original specimen and *5 represents the 0.2 mL (200 microliter) inoculation of the specimen; Dilution is the dilution factor for that plate. Baseline (Day 0) was defined as the mean of Day -2 and Day -1; if data was available at only one of these timepoints then that value was used as Baseline.

Outcome measures

Measure	Rifafour e-275 n=17 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change in log10 CFU/mL of Direct Respiratory Sputum Samples From Baseline to Day 2	-0.598 log10CFU/mL Standard Error 0.0801	0.250 log10CFU/mL Standard Error 0.1077	-0.153 log10CFU/mL Standard Error 0.0801	-0.055 log10CFU/mL Standard Error 0.0832	-0.040 log10CFU/mL Standard Error 0.0855

SECONDARY outcome

Timeframe: Day 2 to Day 14

Population: Efficacy Population consisted of participants in the safety population who provided at least two evaluable overnight sputum samples. Only those participants with data available at specified time points were analyzed.

The Early Bactericidal Activity was determined by change in log10CFU per mL of sputum over the period Day 2 to Day 14. Log(CFU) was calculated as: Log(CFU/mL)=log10(mean[Total count 1:Total Count 2]*2*5*10^Dilution); where total counts 1 and 2 were bacterial counts from plates 1 and 2 respectively; *2 represents the 1:1 dilution of the original specimen and *5 represents the 0.2 mL (200 microliter) inoculation of the specimen; Dilution is the dilution factor for that plate.

Outcome measures

Measure	Rifafour e-275 n=17 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=16 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=14 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change in log10 CFU Per mL of Direct Respiratory Sputum Samples From Day 2 to Day 14	-0.162 log10CFU/mL Standard Error 0.0169	-0.037 log10CFU/mL Standard Error 0.0233	-0.080 log10CFU/mL Standard Error 0.0173	-0.086 log10CFU/mL Standard Error 0.0181	-0.129 log10CFU/mL Standard Error 0.0192

SECONDARY outcome

Timeframe: Baseline and up to Day 14

Population: Efficacy Population consisted of participants in the safety population who provided at least two evaluable overnight sputum samples.

The Early Bactericidal Activity was determined by change in TTP per mL sputum over the period Baseline to Day 14. The TTP was measured in the Mycobacterial Growth Indicator Tube (MGIT) automated liquid culture system of time to positivity of Mycobacterium tuberculosis from an overnight sputum collection. Time to sputum-culture positivity was the time between sample inoculation and detection of mycobacterial growth in the mycobacterium growth indicator tube. Baseline (Day 0) was defined as the mean of Day -2 and Day -1; if data was available at only one of these timepoints then that value was used as Baseline.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change in log10 Time to Sputum Culture Positivity (TTP) From Baseline to Day 14	0.025 log10hours Standard Error 0.0010	0.000 log10hours Standard Error 0.0015	0.015 log10hours Standard Error 0.0011	0.021 log10hours Standard Error 0.0012	0.022 log10hours Standard Error 0.0013

SECONDARY outcome

Timeframe: Baseline and up to Day 2

Population: Efficacy Population consisted of participants in the safety population who provided at least two evaluable overnight sputum samples.

The Early Bactericidal Activity was determined by change in TTP per mL sputum over the period Baseline to Day 2. The TTP was measured in the MGIT automated liquid culture system of time to positivity of Mycobacterium tuberculosis from an overnight sputum collection. Time to sputum-culture positivity was the time between sample inoculation and detection of mycobacterial growth in the mycobacterium growth indicator tube. Baseline (Day 0) was defined as the mean of Day -2 and Day -1; if data was available at only one of these timepoints then that value was used as Baseline.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change in log10 TTP From Baseline to Day 2	0.105 log10hours Standard Error 0.0068	-0.003 log10hours Standard Error 0.0096	0.021 log10hours Standard Error 0.0071	0.032 log10hours Standard Error 0.0072	0.066 log10hours Standard Error 0.0074

SECONDARY outcome

Timeframe: Day 2 to Day 14

Population: Efficacy Population consisted of participants in the safety population who provided at least two evaluable overnight sputum samples. Only those participants with data available at specified time points were analyzed.

The Early Bactericidal Activity was determined by change in TTP per mL sputum over the period Day 2 to Day 14. The TTP was measured in the MGIT automated liquid culture system of time to positivity of Mycobacterium tuberculosis from an overnight sputum collection. Time to sputum-culture positivity was the time between sample inoculation and detection of mycobacterial growth in the mycobacterium growth indicator tube.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=16 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change in log10 TTP From Day 2 to Day 14	0.017 log10hours Standard Error 0.0011	0.001 log10hours Standard Error 0.0016	0.013 log10hours Standard Error 0.0012	0.017 log10hours Standard Error 0.0012	0.016 log10hours Standard Error 0.0013

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 14

Population: PK Population consisted of participants in the safety population who received at least one dose of GSK3036656 and had at least one evaluable PK sample. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3036656.

Outcome measures

Measure	Rifafour e-275 n=8 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=14 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=14 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=13 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Area Under the Plasma Drug Concentration Versus Time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) Following Once Daily Dosing of GSK3036656	281.8 Hours*nanogram per milliliter Geometric Coefficient of Variation 25.7	1495.6 Hours*nanogram per milliliter Geometric Coefficient of Variation 12.5	4493.8 Hours*nanogram per milliliter Geometric Coefficient of Variation 12.5	11505.6 Hours*nanogram per milliliter Geometric Coefficient of Variation 17.9	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 14

Population: PK Population consisted of participants in the safety population who received at least one dose of GSK3036656 and had at least one evaluable PK sample. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for PK analysis of GSK3036656.

Outcome measures

Measure	Rifafour e-275 n=8 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=14 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=14 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=13 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Area Under the Plasma Concentration Time Curve From Zero to 24 Hours (AUC[0-24]) Following Once Daily Dosing of GSK3036656	282.1 Hours*nanogram per milliliter Geometric Coefficient of Variation 25.8	1497.1 Hours*nanogram per milliliter Geometric Coefficient of Variation 12.4	4493.9 Hours*nanogram per milliliter Geometric Coefficient of Variation 12.5	11540.0 Hours*nanogram per milliliter Geometric Coefficient of Variation 17.8	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 14

Population: PK Population consisted of participants in the safety population who received at least one dose of GSK3036656 and had at least one evaluable PK sample. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for PK analysis of GSK3036656.

Outcome measures

Measure	Rifafour e-275 n=8 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=14 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=14 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=13 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Maximum Observed Plasma Drug Concentration (Cmax) Following Once Daily Dosing of GSK3036656	16.93 Nanogram per milliliter Geometric Coefficient of Variation 23.7	94.60 Nanogram per milliliter Geometric Coefficient of Variation 24.7	291.41 Nanogram per milliliter Geometric Coefficient of Variation 18.9	705.24 Nanogram per milliliter Geometric Coefficient of Variation 20.2	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 14

Population: PK Population consisted of participants in the safety population who received at least one dose of GSK3036656 and had at least one evaluable PK sample. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points for PK analysis of GSK3036656.

Outcome measures

Measure	Rifafour e-275 n=8 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=14 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=14 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=13 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Time to Reach Cmax (Tmax) Following Once Daily Dosing of GSK3036656	1.500 Hours Interval 0.5 to 6.0	2.492 Hours Interval 0.5 to 4.0	1.000 Hours Interval 0.5 to 4.0	2.000 Hours Interval 0.5 to 8.0	—

SECONDARY outcome

Timeframe: Up to Day 28 (follow-up visit)

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

An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Non-SAEs	14 Participants	7 Participants	14 Participants	15 Participants	9 Participants
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) SAEs1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, and platelet count. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count Basophils	-0.006 10^9 cells per liter Standard Deviation 0.0281	-0.009 10^9 cells per liter Standard Deviation 0.0242	-0.018 10^9 cells per liter Standard Deviation 0.0248	-0.003 10^9 cells per liter Standard Deviation 0.0263	-0.005 10^9 cells per liter Standard Deviation 0.0267
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count Eosinophils	0.086 10^9 cells per liter Standard Deviation 0.1383	0.075 10^9 cells per liter Standard Deviation 0.1135	0.088 10^9 cells per liter Standard Deviation 0.1239	0.072 10^9 cells per liter Standard Deviation 0.0880	0.057 10^9 cells per liter Standard Deviation 0.0642
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count Lymphocytes	0.051 10^9 cells per liter Standard Deviation 0.3024	-0.066 10^9 cells per liter Standard Deviation 0.3066	0.157 10^9 cells per liter Standard Deviation 0.4010	0.099 10^9 cells per liter Standard Deviation 0.5175	0.136 10^9 cells per liter Standard Deviation 0.3861
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count Monocytes	-0.073 10^9 cells per liter Standard Deviation 0.3236	-0.156 10^9 cells per liter Standard Deviation 0.1467	-0.125 10^9 cells per liter Standard Deviation 0.1376	-0.301 10^9 cells per liter Standard Deviation 0.3647	-0.242 10^9 cells per liter Standard Deviation 0.2225
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count Total neutrophils	-0.940 10^9 cells per liter Standard Deviation 1.9563	-0.509 10^9 cells per liter Standard Deviation 0.9609	-0.613 10^9 cells per liter Standard Deviation 1.4654	-1.633 10^9 cells per liter Standard Deviation 1.6475	-0.949 10^9 cells per liter Standard Deviation 1.2011
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count Platelet count	-59.6 10^9 cells per liter Standard Deviation 105.19	-35.0 10^9 cells per liter Standard Deviation 83.00	-93.6 10^9 cells per liter Standard Deviation 81.05	-7.3 10^9 cells per liter Standard Deviation 81.33	-78.6 10^9 cells per liter Standard Deviation 43.53

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Hematology Parameter: Hemoglobin	-3.4 Grams per liter Standard Deviation 9.15	-2.9 Grams per liter Standard Deviation 6.64	0.0 Grams per liter Standard Deviation 7.32	1.7 Grams per liter Standard Deviation 9.21	-4.6 Grams per liter Standard Deviation 14.99

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Hematology Parameter: Hematocrit	-0.012 Proportion of red blood cells in blood Standard Deviation 0.0308	-0.008 Proportion of red blood cells in blood Standard Deviation 0.0225	0.003 Proportion of red blood cells in blood Standard Deviation 0.0247	0.007 Proportion of red blood cells in blood Standard Deviation 0.0277	-0.018 Proportion of red blood cells in blood Standard Deviation 0.0454

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: red blood cells count. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Hematology Parameter: Red Blood Cells Count	-0.130 10^12 cells per liter Standard Deviation 0.3067	-0.091 10^12 cells per liter Standard Deviation 0.2776	0.016 10^12 cells per liter Standard Deviation 0.2753	0.059 10^12 cells per liter Standard Deviation 0.2875	-0.216 10^12 cells per liter Standard Deviation 0.6590

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: mean corpuscular volume. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume	0.2 Femtoliter Standard Deviation 1.92	-0.3 Femtoliter Standard Deviation 0.89	0.1 Femtoliter Standard Deviation 1.36	0.5 Femtoliter Standard Deviation 0.92	0.0 Femtoliter Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin	0.2 Picograms Standard Deviation 0.65	-0.1 Picograms Standard Deviation 0.64	-0.1 Picograms Standard Deviation 0.64	0.1 Picograms Standard Deviation 0.70	0.3 Picograms Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the hematology parameter: reticulocytes. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Hematology Parameter: Reticulocytes	0.0045 Percentage of reticulocytes Standard Deviation 0.00568	0.0035 Percentage of reticulocytes Standard Deviation 0.00245	0.0041 Percentage of reticulocytes Standard Deviation 0.00255	0.0055 Percentage of reticulocytes Standard Deviation 0.00374	0.0025 Percentage of reticulocytes Standard Deviation 0.00456

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameters: glucose, calcium, chloride, potassium, sodium, and blood urea nitrogen. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium, Blood Urea Nitrogen Glucose	-0.29 Millimoles per liter Standard Deviation 0.734	0.05 Millimoles per liter Standard Deviation 0.809	0.17 Millimoles per liter Standard Deviation 1.047	-0.30 Millimoles per liter Standard Deviation 0.902	-0.86 Millimoles per liter Standard Deviation 1.477
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium, Blood Urea Nitrogen Calcium	0.021 Millimoles per liter Standard Deviation 0.0814	-0.018 Millimoles per liter Standard Deviation 0.1007	-0.034 Millimoles per liter Standard Deviation 0.0672	0.005 Millimoles per liter Standard Deviation 0.0633	-0.024 Millimoles per liter Standard Deviation 0.0860
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium, Blood Urea Nitrogen Chloride	1.1 Millimoles per liter Standard Deviation 2.14	1.0 Millimoles per liter Standard Deviation 1.69	1.6 Millimoles per liter Standard Deviation 2.59	2.3 Millimoles per liter Standard Deviation 2.25	2.3 Millimoles per liter Standard Deviation 3.79
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium, Blood Urea Nitrogen Potassium	-0.39 Millimoles per liter Standard Deviation 0.398	-0.79 Millimoles per liter Standard Deviation 0.925	-0.47 Millimoles per liter Standard Deviation 0.403	-0.15 Millimoles per liter Standard Deviation 0.521	-0.28 Millimoles per liter Standard Deviation 0.521
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium, Blood Urea Nitrogen Sodium	0.4 Millimoles per liter Standard Deviation 2.33	1.0 Millimoles per liter Standard Deviation 1.60	0.7 Millimoles per liter Standard Deviation 2.55	2.1 Millimoles per liter Standard Deviation 3.49	0.5 Millimoles per liter Standard Deviation 3.10
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium, Blood Urea Nitrogen Blood urea nitrogen	-0.054 Millimoles per liter Standard Deviation 0.3207	-0.169 Millimoles per liter Standard Deviation 0.5493	0.125 Millimoles per liter Standard Deviation 0.3074	0.145 Millimoles per liter Standard Deviation 0.2860	0.042 Millimoles per liter Standard Deviation 0.3198

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameters: LDH, ALT, ALP, AST and GGT. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Chemistry Parameters: Lactate Dehydrogenase (LDH), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) GGT	-3.9 International units per liter Standard Deviation 22.20	-51.0 International units per liter Standard Deviation 76.64	-14.9 International units per liter Standard Deviation 28.18	-16.4 International units per liter Standard Deviation 30.83	-5.2 International units per liter Standard Deviation 23.23
Change From Baseline in Chemistry Parameters: Lactate Dehydrogenase (LDH), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) LDH	-56.3 International units per liter Standard Deviation 57.81	-52.8 International units per liter Standard Deviation 72.99	-18.3 International units per liter Standard Deviation 36.22	-26.5 International units per liter Standard Deviation 57.92	-8.5 International units per liter Standard Deviation 73.83
Change From Baseline in Chemistry Parameters: Lactate Dehydrogenase (LDH), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) ALT	-20.6 International units per liter Standard Deviation 35.79	-37.0 International units per liter Standard Deviation 62.35	-8.1 International units per liter Standard Deviation 18.22	-11.0 International units per liter Standard Deviation 18.60	5.9 International units per liter Standard Deviation 20.77
Change From Baseline in Chemistry Parameters: Lactate Dehydrogenase (LDH), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) ALP	-3.1 International units per liter Standard Deviation 21.22	-34.1 International units per liter Standard Deviation 61.88	-16.8 International units per liter Standard Deviation 32.52	-4.0 International units per liter Standard Deviation 70.73	-7.5 International units per liter Standard Deviation 13.06
Change From Baseline in Chemistry Parameters: Lactate Dehydrogenase (LDH), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT) AST	-13.7 International units per liter Standard Deviation 22.27	-12.9 International units per liter Standard Deviation 13.94	-5.6 International units per liter Standard Deviation 9.86	-8.4 International units per liter Standard Deviation 13.47	2.2 International units per liter Standard Deviation 8.74

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameters: creatinine, indirect bilirubin, direct bilirubin and total bilirubin. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Chemistry Parameters: Creatinine, Indirect Bilirubin, Direct Bilirubin and Total Bilirubin Creatinine	0.6 Micromoles per liter Standard Deviation 6.09	2.8 Micromoles per liter Standard Deviation 4.74	3.1 Micromoles per liter Standard Deviation 9.13	1.5 Micromoles per liter Standard Deviation 6.24	0.6 Micromoles per liter Standard Deviation 5.08
Change From Baseline in Chemistry Parameters: Creatinine, Indirect Bilirubin, Direct Bilirubin and Total Bilirubin Indirect bilirubin	-1.2 Micromoles per liter Standard Deviation 1.08	-0.9 Micromoles per liter Standard Deviation 1.07	-0.1 Micromoles per liter Standard Deviation 1.51	-1.1 Micromoles per liter Standard Deviation 1.71	0.3 Micromoles per liter Standard Deviation 1.03
Change From Baseline in Chemistry Parameters: Creatinine, Indirect Bilirubin, Direct Bilirubin and Total Bilirubin Direct bilirubin	-0.6 Micromoles per liter Standard Deviation 0.70	-0.5 Micromoles per liter Standard Deviation 1.07	0.0 Micromoles per liter Standard Deviation 0.76	-0.7 Micromoles per liter Standard Deviation 0.90	-0.7 Micromoles per liter Standard Deviation 1.38
Change From Baseline in Chemistry Parameters: Creatinine, Indirect Bilirubin, Direct Bilirubin and Total Bilirubin Total bilirubin	-1.5 Micromoles per liter Standard Deviation 1.34	-1.1 Micromoles per liter Standard Deviation 1.81	-0.1 Micromoles per liter Standard Deviation 1.51	-1.7 Micromoles per liter Standard Deviation 2.05	0.0 Micromoles per liter Standard Deviation 1.58

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Blood samples were collected to analyze the chemistry parameter: total protein. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in Chemistry Parameter: Total Protein	-1.7 Grams per liter Standard Deviation 3.72	-1.0 Grams per liter Standard Deviation 6.46	-1.3 Grams per liter Standard Deviation 4.73	2.2 Grams per liter Standard Deviation 6.73	-4.2 Grams per liter Standard Deviation 5.83

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and up to Day 28 (follow-up visit)

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

Urine samples were collected to assess urine occult blood and urine protein. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased and increase to abnormal for urine occult blood and protein indicating proportional concentrations in the urine sample. 'No change/decreased' means no change from Baseline or a value less than the Baseline value. 'Increase to abnormal' means an increase from the Baseline value that is considered as an abnormal value. Baseline value is the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits. Data for worst-case post Baseline is presented.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Occult blood: No change/decrease	15 Participants	9 Participants	16 Participants	14 Participants	9 Participants
Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Protein: No change/decrease	8 Participants	5 Participants	9 Participants	10 Participants	9 Participants
Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Occult blood: Increase to abnormal	3 Participants	0 Participants	1 Participants	2 Participants	6 Participants
Number of Participants With Worst-Case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method Protein: Increase to abnormal	10 Participants	4 Participants	8 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Day 28 (follow-up visit)

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

Vital signs were measured in a semi-supine or supine position after 5 minutes rest. The PCI range for vital signs were: systolic blood pressure (SBP) (lower: <85 and upper: >160 milliliter of mercury [mmHg]); diastolic blood pressure (DBP) (lower: <45 and upper: >100 mmHg); heart rate (lower: <40 and upper: >110 beats per minute [bpm]); respiratory rate (lower: 10 and upper: 28 breaths per minutes) and temperature (lower: <35 and upper: >37.9 degrees Celsius). Participants were counted in the worst-case category that their value changed to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category was unchanged (e.g. High to High), or whose value became within range, were recorded in the "To w/in Range or No Change category". Participants were counted twice if the participant had values that changed "To Low" and "To High".

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline SBP: To low	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline SBP: To within Range or No Change	17 Participants	8 Participants	17 Participants	15 Participants	15 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline SBP: To High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline DBP: To low	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline DBP: To within Range or No Change	16 Participants	7 Participants	16 Participants	16 Participants	15 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline DBP: To High	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Heart rate: To low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Heart rate: To within Range or No Change	16 Participants	6 Participants	15 Participants	15 Participants	15 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Heart rate: To High	2 Participants	3 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Respiratory rate: To low	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Respiratory rate: To within Range or No Change	18 Participants	9 Participants	17 Participants	13 Participants	15 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Respiratory rate: To High	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Temperature: To low	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Temperature: To within Range or No Change	17 Participants	7 Participants	16 Participants	14 Participants	15 Participants
Number of Participants With Worst Case Vital Sign Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline Temperature: To High	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 28 (follow-up visit)

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, uncorrected QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with abnormal clinically significant ECG findings for worst case post-Baseline has been presented.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Abnormal, not clinically significant	13 Participants	5 Participants	12 Participants	12 Participants	10 Participants
Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings Abnormal - clinically significant	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1, Pre-dose) and at Day 14

Population: Safety Population consisted of all randomized participants who received at least one dose of study treatment. Only those participants with data available at specified time points were analyzed.

Twelve-lead ECGs were obtained to QTcF Interval and measured QT duration corrected for heart rate by Fridericia's formula interval. Baseline value was the latest assessment prior to Day 1 dose with a non-missing value, including those from unscheduled visits and the mean of the triplicate measurements at any given time point was used as the value for that time point. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit (Day 14) value.

Outcome measures

Measure	Rifafour e-275 n=18 Participants All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=8 Participants Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=15 Participants Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=15 Participants Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=13 Participants Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)	6.4 Milliseconds Standard Deviation 13.64	11.3 Milliseconds Standard Deviation 14.40	-1.8 Milliseconds Standard Deviation 20.48	9.5 Milliseconds Standard Deviation 14.91	4.0 Milliseconds Standard Deviation 16.76

Adverse Events

Rifafour e-275

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

GSK3036656 1 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

GSK3036656 5 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

GSK3036656 15 mg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

GSK3036656 30 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rifafour e-275 n=18 participants at risk All participants received a standard-of-care therapy ( rifafour e-275) tablet, orally, once daily from Day 1 to Day 14. Participants received the standard treatment for tuberculosis (i.e. rifafour e-275 or equivalent generic alternative) once the study treatment (Day 1 to Day 14) was completed.	GSK3036656 1 mg n=9 participants at risk Participants received a loading dose of GSK3036656 3 milligram (mg), capsule, orally on Day 1, followed by maintenance dose of GSK3036656 1 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 5 mg n=17 participants at risk Participants received a loading dose of GSK3036656 15 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 5 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 15 mg n=16 participants at risk Participants received a loading dose of GSK3036656 30 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 15 mg, orally, once daily from Day 2 to Day 14.	GSK3036656 30 mg n=15 participants at risk Participants received a loading dose of GSK3036656 75 mg, capsule, orally on Day 1, followed by maintenance dose of GSK3036656 30 mg, orally, once daily from Day 2 to Day 14.
Gastrointestinal disorders Abdominal pain	16.7% 3/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	13.3% 2/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	11.1% 2/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	12.5% 2/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	13.3% 2/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.8% 2/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Odynophagia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	11.1% 2/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	22.2% 2/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	25.0% 4/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash pruritic	11.1% 2/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash papular	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	12.5% 2/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin hypopigmentation	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Acne	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Blister	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Headache	16.7% 3/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	22.2% 2/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	12.5% 2/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	11.1% 2/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Neuropathy peripheral	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Somnolence	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	11.1% 2/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	29.4% 5/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	12.5% 2/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.8% 2/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dry throat	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 2/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	25.0% 4/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	12.5% 2/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Carbuncle	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Conjunctivitis	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Fungal skin infection	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Otitis externa	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Pulmonary tuberculosis	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Infections and infestations Tinea versicolour	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.8% 2/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Chest pain	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Injection site pain	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Peripheral swelling	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Pyrexia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
General disorders Vessel puncture site pain	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Eye disorders Eye irritation	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Eye disorders Uveitis	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Investigations Blood pressure increased	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Investigations Ejection fraction decreased	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.7% 1/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Investigations Electrocardiogram PR prolongation	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Palpitations	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Cardiac disorders Ventricular hypokinesia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	11.1% 1/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Ear and labyrinth disorders Ear pain	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Ear and labyrinth disorders Noninfective myringitis	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Vascular disorders Flushing	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Vascular disorders Orthostatic hypotension	5.6% 1/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Immune system disorders Hypersensitivity	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	5.9% 1/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/18 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/9 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/17 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	6.2% 1/16 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.	0.00% 0/15 • All-cause mortality, SAEs and non-SAEs were collected up to Day 28 (follow-up visit) Safety Population consisted of all randomized participants who received at least one dose of study treatment.

Additional Information

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