Trial Outcomes & Findings for Drug-drug Interaction Study of Gepotidacin (NCT NCT04493931)

Results Overview

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric least square (LS) mean and 90 percent (%) confidence interval (CI) of the geometric LS means have been presented.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

64 participants

Primary outcome timeframe

Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Results posted on

2022-03-04

Participant Flow

This study was conducted at a single center in the United States and designed to assess co-administration of probe substrates with gepotidacin in study Cohorts 1 to 3 and establishing pharmacokinetics and safety in a Japanese cohort in Cohort 4.

A total of 64 participants (14 in Cohort 1, 17 in Cohort 2, 19 in Cohort 3 and 14 participants in Cohort 4) were enrolled in the study.

Participant milestones

Participant milestones
Measure	Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg Participants received a single oral dose of gepotidacin 1500 milligrams (mg) on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants were administered with cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2. Participants had a follow-up of 7 days after the last dose of cimetidine.	Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) along with a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2. Participants had a follow-up of 10 days after the last dose of rifampicin.	Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.	Cohort 3: Gepotidacin 3000 mg + Digoxin + Midazolam/Digoxin+Midazolam Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.	Cohort 4:Gepotidacin 1500 mg Fed/Gepotidacin 1500 mg Fasted/Gepotidacin 3000 mg Fed Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 followed by a washout of 3 days . In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.	Cohort 4:Gepotidacin 1500 mg Fasted/Gepotidacin 1500 mg Fed/Gepotidacin 3000 mg Fed Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.	Cohort 4: Placebo Fed/ Placebo Fasted/ Placebo Fed Japanese participants received a single dose of placebo matching gepotidacin under fed conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of placebo matching gepotidacin under fasted conditions on Day 1 of Period 2, followed by a washout of 3 days. In Period 3, participants were administered with two doses of placebo matching gepotidacin (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days.
Cohort1:Treatment Period 1(Up to 3 Days) STARTED	14	0	0	0	0	0	0
Cohort1:Treatment Period 1(Up to 3 Days) COMPLETED	13	0	0	0	0	0	0
Cohort1:Treatment Period 1(Up to 3 Days) NOT COMPLETED	1	0	0	0	0	0	0
Cohort 1:Washout Period 1 (Up to 3 Days) STARTED	13	0	0	0	0	0	0
Cohort 1:Washout Period 1 (Up to 3 Days) COMPLETED	13	0	0	0	0	0	0
Cohort 1:Washout Period 1 (Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort1:Treatment Period 2(Up to 4 Days) STARTED	13	0	0	0	0	0	0
Cohort1:Treatment Period 2(Up to 4 Days) COMPLETED	13	0	0	0	0	0	0
Cohort1:Treatment Period 2(Up to 4 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort 1: Follow-up (Up to 7 Days) STARTED	13	0	0	0	0	0	0
Cohort 1: Follow-up (Up to 7 Days) COMPLETED	13	0	0	0	0	0	0
Cohort 1: Follow-up (Up to 7 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort2:Treatment Period 1(Up to 3 Days) STARTED	0	17	0	0	0	0	0
Cohort2:Treatment Period 1(Up to 3 Days) COMPLETED	0	17	0	0	0	0	0
Cohort2:Treatment Period 1(Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort 2:Washout Period 1(Up to 3 Days) STARTED	0	17	0	0	0	0	0
Cohort 2:Washout Period 1(Up to 3 Days) COMPLETED	0	17	0	0	0	0	0
Cohort 2:Washout Period 1(Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort2:Treatment Period2(Up to 10 Days) STARTED	0	17	0	0	0	0	0
Cohort2:Treatment Period2(Up to 10 Days) COMPLETED	0	14	0	0	0	0	0
Cohort2:Treatment Period2(Up to 10 Days) NOT COMPLETED	0	3	0	0	0	0	0
Cohort 2: Follow-up (Up to 10 Days) STARTED	0	14	0	0	0	0	0
Cohort 2: Follow-up (Up to 10 Days) COMPLETED	0	14	0	0	0	0	0
Cohort 2: Follow-up (Up to 10 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort3:Treatment Period 1(Up to 5 Days) STARTED	0	0	10	9	0	0	0
Cohort3:Treatment Period 1(Up to 5 Days) COMPLETED	0	0	9	9	0	0	0
Cohort3:Treatment Period 1(Up to 5 Days) NOT COMPLETED	0	0	1	0	0	0	0
Cohort3:Washout Period 1(Up to 10 Days) STARTED	0	0	9	9	0	0	0
Cohort3:Washout Period 1(Up to 10 Days) COMPLETED	0	0	9	9	0	0	0
Cohort3:Washout Period 1(Up to 10 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort3:Treatment Period 2(Up to 5 Days) STARTED	0	0	9	9	0	0	0
Cohort3:Treatment Period 2(Up to 5 Days) COMPLETED	0	0	9	9	0	0	0
Cohort3:Treatment Period 2(Up to 5 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort 3: Follow-up (Up to 10 Days) STARTED	0	0	9	9	0	0	0
Cohort 3: Follow-up (Up to 10 Days) COMPLETED	0	0	9	9	0	0	0
Cohort 3: Follow-up (Up to 10 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort4:Treatment Period 1(Up to 3 Days) STARTED	0	0	0	0	6	5	3
Cohort4:Treatment Period 1(Up to 3 Days) COMPLETED	0	0	0	0	6	5	3
Cohort4:Treatment Period 1(Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort4:Washout Period 1(Up to 3 Days) STARTED	0	0	0	0	6	5	3
Cohort4:Washout Period 1(Up to 3 Days) COMPLETED	0	0	0	0	6	5	3
Cohort4:Washout Period 1(Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort4:Treatment Period 2(Up to 3 Days) STARTED	0	0	0	0	6	5	3
Cohort4:Treatment Period 2(Up to 3 Days) COMPLETED	0	0	0	0	6	5	3
Cohort4:Treatment Period 2(Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort4:Washout Period 2(Up to 3 Days) STARTED	0	0	0	0	6	5	3
Cohort4:Washout Period 2(Up to 3 Days) COMPLETED	0	0	0	0	6	5	3
Cohort4:Washout Period 2(Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort4:Treatment Period 3(Up to 3 Days) STARTED	0	0	0	0	6	5	3
Cohort4:Treatment Period 3(Up to 3 Days) COMPLETED	0	0	0	0	6	5	3
Cohort4:Treatment Period 3(Up to 3 Days) NOT COMPLETED	0	0	0	0	0	0	0
Cohort 4: Follow-up (Up to 7 Days) STARTED	0	0	0	0	6	5	3
Cohort 4: Follow-up (Up to 7 Days) COMPLETED	0	0	0	0	6	5	3
Cohort 4: Follow-up (Up to 7 Days) NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg Participants received a single oral dose of gepotidacin 1500 milligrams (mg) on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants were administered with cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2. Participants had a follow-up of 7 days after the last dose of cimetidine.	Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) along with a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2. Participants had a follow-up of 10 days after the last dose of rifampicin.	Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.
Cohort1:Treatment Period 1(Up to 3 Days) Adverse Event	1	0	0
Cohort2:Treatment Period2(Up to 10 Days) Physician Decision	0	2	0
Cohort2:Treatment Period2(Up to 10 Days) Withdrawal by Subject	0	1	0
Cohort3:Treatment Period 1(Up to 5 Days) Protocol Violation	0	0	1

Baseline Characteristics

Drug-drug Interaction Study of Gepotidacin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Gepotidacin 1500 mg/Cimetidine + Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 milligrams (mg) on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants were administered with cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2. Participants had a follow-up of 7 days after the last dose of cimetidine.	Cohort 2: Gepotidacin 1500 mg/Gepotidacin 1500 mg + Rifampicin n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 followed by a washout of at least 3 days. In Period 2, participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) along with a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2. Participants had a follow-up of 10 days after the last dose of rifampicin.	Cohort 3: Digoxin+Midazolam/Gepotidacin 3000 mg + Digoxin + Midazolam n=10 Participants Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.	Cohort 3: Gepotidacin 3000 mg + Digoxin + Midazolam/Digoxin+Midazolam n=9 Participants Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 followed by a washout of 10 days. In Period 2, participants were administered with digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 2. Participants had a follow-up of 10 days after the last dose of study treatment in Period 2.	Cohort 4:Gepotidacin 1500 mg Fed/Gepotidacin 1500 mg Fasted/Gepotidacin 3000 mg Fed n=6 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 followed by a washout of 3 days . In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.	Cohort 4:Gepotidacin 1500 mg Fasted/Gepotidacin 1500 mg Fed/Gepotidacin 3000 mg Fed n=5 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 2 followed by a washout of 3 days. In Period 3, participants were administered with two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days after the last dose of gepotidacin.	Cohort 4: Placebo Fed/ Placebo Fasted/ Placebo Fed n=3 Participants Japanese participants received a single dose of placebo matching gepotidacin under fed conditions on Day 1 of Period 1 followed by a a washout of 3 days. In Period 2, participants were administered with a single dose of placebo matching gepotidacin under fasted conditions on Day 1 of Period 2, followed by a washout of 3 days. In Period 3, participants were administered with two doses of placebo matching gepotidacin (given 12 hours apart) under fed conditions on Day 1 of Period 3. Participants had a follow-up of 7 days.	Total n=64 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Age, Customized 18-64 years	14 Participants n=99 Participants	17 Participants n=107 Participants	10 Participants n=206 Participants	9 Participants n=7 Participants	6 Participants n=31 Participants	5 Participants n=30 Participants	3 Participants n=3 Participants	64 Participants n=6 Participants
Age, Customized >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Sex: Female, Male Female	7 Participants n=99 Participants	4 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	2 Participants n=31 Participants	2 Participants n=30 Participants	2 Participants n=3 Participants	25 Participants n=6 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	13 Participants n=107 Participants	7 Participants n=206 Participants	4 Participants n=7 Participants	4 Participants n=31 Participants	3 Participants n=30 Participants	1 Participants n=3 Participants	39 Participants n=6 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	8 Participants n=99 Participants	7 Participants n=107 Participants	6 Participants n=206 Participants	5 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	26 Participants n=6 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	2 Participants n=6 Participants
Race/Ethnicity, Customized WHITE	4 Participants n=99 Participants	5 Participants n=107 Participants	4 Participants n=206 Participants	4 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	17 Participants n=6 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN/WHITE	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized ASIAN(A)/BLACK OR AFRICAN AMERICAN	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized JAPANESE HERITAGE(H)/EAST A H/SOUTH EAST A H	0 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	6 Participants n=31 Participants	5 Participants n=30 Participants	3 Participants n=3 Participants	16 Participants n=6 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE/WHITE	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population comprised of all participants in the Pharmacokinetic Population (received at least 1 dose of study intervention and had at least 1 non-missing plasma or urine pharmacokinetic concentration) who received study intervention for whom valid and evaluable plasma or urine pharmacokinetic parameters were derived.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric least square (LS) mean and 90 percent (%) confidence interval (CI) of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma	4.817 Micrograms per milliliter Interval 4.006 to 5.793	4.548 Micrograms per milliliter Interval 3.756 to 5.506	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of Gepotidacin in Plasma	2.500 Hours Interval 1.0 to 4.0	2.500 Hours Interval 1.0 to 4.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Terminal Phase Half-life (t1/2) of Gepotidacin in Plasma	11.344 Hours Interval 10.282 to 12.516	12.415 Hours Interval 11.207 to 13.754	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Gepotidacin in Plasma	20.3 Hours*micrograms per milliliter Interval 17.7 to 23.3	23.4 Hours*micrograms per milliliter Interval 20.4 to 26.9	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: AUC From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of Gepotidacin in Plasma	20.6 Hours* micrograms per milliliter Interval 18.0 to 23.6	23.9 Hours* micrograms per milliliter Interval 20.8 to 27.4	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Cmax of Gepotidacin in Plasma	3.735 Micrograms per milliliter Interval 3.209 to 4.347	2.728 Micrograms per milliliter Interval 2.323 to 3.202	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Lag Time Before Observation of Drug Concentrations (Tlag) of Gepotidacin in Plasma	0.000 Hours Interval 0.0 to 1.0	0.000 Hours Interval 0.0 to 0.5	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Tmax of Gepotidacin in Plasma	2.500 Hours Interval 1.0 to 6.0	2.000 Hours Interval 1.0 to 4.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: AUC(0-t) of Gepotidacin in Plasma	19.0 Hours*micrograms per milliliter Interval 16.9 to 21.3	9.0 Hours*micrograms per milliliter Interval 8.0 to 10.2	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: AUC(0-infinity) of Gepotidacin in Plasma	19.3 Hours*micrograms per milliliter Interval 17.2 to 21.7	9.3 Hours*micrograms per milliliter Interval 8.2 to 10.4	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Cmax of Digoxin in Plasma	1553.135 Picograms per milliliter Interval 1318.39 to 1829.676	2381.259 Picograms per milliliter Interval 2013.503 to 2816.185	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Tlag of Digoxin in Plasma	0.000 Hours Interval 0.0 to 0.0	0.000 Hours Interval 0.0 to 0.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Tmax of Digoxin in Plasma	2.000 Hours Interval 0.5 to 4.0	1.275 Hours Interval 0.5 to 4.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=17 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-t) of Digoxin in Plasma	25353.1 Hours*picograms per milliliter Interval 22490.9 to 28579.6	30842.3 Hours*picograms per milliliter Interval 27241.5 to 34919.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-infinity) of Digoxin in Plasma	30743.6 Hours*picograms per milliliter Interval 27425.5 to 34463.1	34456.5 Hours*picograms per milliliter Interval 30652.1 to 38733.1	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Cmax of Midazolam in Plasma	5.238 Nanograms per milliliter Interval 4.436 to 6.185	6.507 Nanograms per milliliter Interval 5.492 to 7.711	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Tlag of Midazolam in Plasma	0.000 Hours Interval 0.0 to 0.0	0.000 Hours Interval 0.0 to 0.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Tmax of Midazolam in Plasma	0.650 Hours Interval 0.5 to 2.5	0.500 Hours Interval 0.5 to 4.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-t) of Midazolam in Plasma	23.3 Hours*nanograms per milliliter Interval 19.5 to 27.9	44.8 Hours*nanograms per milliliter Interval 37.4 to 53.8	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-infinity) of Midazolam in Plasma	24.9 Hours*nanograms per milliliter Interval 21.1 to 29.6	47.4 Hours*nanograms per milliliter Interval 39.9 to 56.4	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma	5.436 Micrograms per milliliter Geometric Coefficient of Variation 27.8	5.143 Micrograms per milliliter Geometric Coefficient of Variation 34.2	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma	2.000 Hours Interval 1.5 to 4.0	1.500 Hours Interval 1.0 to 4.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 24 Hours Post-dose (AUC[0-24]) of Gepotidacin Following Single Dose of 1500 mg in Plasma	20.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 16.8	19.0 Hours*micrograms per milliliter Geometric Coefficient of Variation 12.9	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Area Under the Concentration-time Curve From Time 0 (Pre-dose) to the Concentration at 48 Hours Post-dose (AUC[0-48]) of Gepotidacin Following Single Dose of 1500 mg in Plasma	21.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 16.0	20.0 Hours*micrograms per milliliter Geometric Coefficient of Variation 13.2	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma	21.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 16.0	20.0 Hours*micrograms per milliliter Geometric Coefficient of Variation 13.2	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma	22.3 Hours*micrograms per milliliter Geometric Coefficient of Variation 15.5	20.4 Hours*micrograms per milliliter Geometric Coefficient of Variation 13.3	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State	11.204 Micrograms per milliliter Geometric Coefficient of Variation 45.0	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg -Fed State	2.000 Hours Interval 1.0 to 4.0	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC From Time 0 (Predose) to Time Tau (AUC[0-tau]) of Gepotidacin in Plasma After the First Dose of 3000 Mg-Fed State	37.3 Hours*micrograms per milliliter Geometric Coefficient of Variation 25.4	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State	12.363 Micrograms per milliliter Geometric Coefficient of Variation 21.3	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State	2.000 Hours Interval 1.0 to 3.0	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Evening Dose)-Fed State	46.7 Hours*micrograms per milliliter Geometric Coefficient of Variation 23.1	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Accumulation Ratio Based on Cmax (RoCmax) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State	1.103 Ratio Geometric Coefficient of Variation 39.3	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Accumulation Ratio Based on AUC(0-tau) (RoAUC) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)-Fed State	1.254 Ratio Geometric Coefficient of Variation 13.1	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State	84.6 Hours*micrograms per milliliter Geometric Coefficient of Variation 23.1	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State	90.8 Hours*micrograms per milliliter Geometric Coefficient of Variation 22.9	—	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State	91.4 Hours*micrograms per milliliter Geometric Coefficient of Variation 23.0	—	—	—

PRIMARY outcome

Timeframe: Up to 22 days

Population: Safety Population comprised of all participants who took at least 1 dose of study intervention.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=3 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted n=11 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed n=11 Participants Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) Any SAE	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE) Any non-SAE	0 Participants	1 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 22 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose laboratory (lab) value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 (%). High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=3 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted n=11 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed n=11 Participants Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Normal or No Change	3 Participants	11 Participants	9 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To High	0 Participants	1 Participants	1 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To High	0 Participants	1 Participants	0 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To High	0 Participants	1 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Low	0 Participants	0 Participants	1 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Normal or No Change	3 Participants	11 Participants	10 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Low	0 Participants	0 Participants	0 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Normal or No Change	3 Participants	11 Participants	11 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To High	0 Participants	0 Participants	2 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Normal or No Change	3 Participants	10 Participants	10 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Normal or No Change	2 Participants	10 Participants	10 Participants	9 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To High	1 Participants	1 Participants	1 Participants	2 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Low	0 Participants	0 Participants	0 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Normal or No Change	3 Participants	10 Participants	11 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To High	0 Participants	1 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Normal or No Change	3 Participants	10 Participants	11 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Normal or No Change	3 Participants	10 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Low	0 Participants	0 Participants	0 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Normal or No Change	3 Participants	11 Participants	11 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants

PRIMARY outcome

Timeframe: Up to 22 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, Blood Urea Nitrogen (BUN). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=3 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted n=11 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed n=11 Participants Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Low	1 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Normal or No Change	2 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	2 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To High	1 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Low	0 Participants	0 Participants	1 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Normal or No Change	3 Participants	11 Participants	10 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Low	1 Participants	0 Participants	0 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Normal or No Change	2 Participants	11 Participants	11 Participants	9 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To High	0 Participants	0 Participants	0 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine;To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Normal or No Change	2 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Normal or No Change	2 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To High	1 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To High	1 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Low	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 22 days

Population: Safety Population

Urine samples were collected at indicated time points for the analysis of urinalysis parameters including potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=3 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted n=11 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed n=11 Participants Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Normal or No Change	2 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Abnormal	1 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Normal or No Change	2 Participants	9 Participants	11 Participants	9 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Abnormal	1 Participants	2 Participants	0 Participants	2 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Normal or No Change	3 Participants	11 Participants	11 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Abnormal	0 Participants	0 Participants	0 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Normal or No Change	2 Participants	11 Participants	10 Participants	10 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Abnormal	1 Participants	0 Participants	1 Participants	1 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Abnormal	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To High	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 22 days

Population: Safety Population

Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal 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 normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=3 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted n=11 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed n=11 Participants Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Low	0 Participants	1 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Normal or No Change	3 Participants	10 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Low	0 Participants	1 Participants	1 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Normal or No Change	3 Participants	10 Participants	10 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To High	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Low	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Normal or No Change	3 Participants	11 Participants	11 Participants	11 Participants
Cohort 4: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To High	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 22 days

Population: Safety Population

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the Bazett formula (QTcB) Interval and corrected QT interval using the Fridericia formula (QTcF) Interval has been reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=3 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted n=11 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed n=11 Participants Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval QTcB Interval	1 Participants	8 Participants	3 Participants	9 Participants
Cohort 4: Number of Participants With Any Increase in Maximum Post-Baseline Electrocardiogram (ECG) Parameter Corrected QT (QTc) Interval QTcF Interval	1 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Cmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants	5.421 Micrograms per milliliter Interval 4.61 to 6.374	5.158 Micrograms per milliliter Interval 4.386 to 6.065	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Tlag of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants	0.000 Hours Interval 0.0 to 0.5	0.000 Hours Interval 0.0 to 0.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Tmax of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants	2.000 Hours Interval 1.5 to 4.0	1.500 Hours Interval 1.0 to 4.0	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-t) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants	21.9 Hours*Micrograms per milliliter Interval 20.3 to 23.7	20.0 Hours*Micrograms per milliliter Interval 18.5 to 21.6	—	—

PRIMARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-infinity) of Gepotidacin Following Single Dose of 1500 mg in Plasma - Food Effect in Japanese Participants	22.3 Hours*Micrograms per milliliter Interval 20.7 to 24.1	20.4 Hours*Micrograms per milliliter Interval 18.9 to 22.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: AUC (0-24) of Gepotidacin in Plasma	19.3 Hours*micrograms per milliliter Geometric Coefficient of Variation 32.6	21.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 29.7	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: AUC(0-48) of Gepotidacin in Plasma	20.3 Hours*micrograms per milliliter Geometric Coefficient of Variation 31.4	23.0 Hours*micrograms per milliliter Geometric Coefficient of Variation 28.4	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Tlag of Gepotidacin in Plasma	0.000 Hours Interval 0.0 to 0.5	0.000 Hours Interval 0.0 to 0.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Apparent Volume of Distribution (Vz/F) of Gepotidacin in Plasma	1190.16 Liters Geometric Coefficient of Variation 34.0	1143.29 Liters Geometric Coefficient of Variation 30.6	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours Post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Apparent Oral Clearance (CL/F) of Gepotidacin in Plasma	72.72 Liters per Hour Geometric Coefficient of Variation 31.2	64.14 Liters per Hour Geometric Coefficient of Variation 28.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=12 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Total Unchanged Drug (Ae Total) of Gepotidacin in Urine	337.92 Milligrams Interval 281.14 to 406.16	410.10 Milligrams Interval 343.16 to 490.08	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours Post-dose in each Treatment periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: AUC(0-24) of Gepotidacin in Urine	3292.1 Hours*micrograms per milliliter Interval 2639.2 to 4106.5	3612.4 Hours*micrograms per milliliter Interval 2888.5 to 4517.7	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: AUC(0-48) of Gepotidacin in Urine	3578.2 Hours*micrograms per milliliter Interval 2890.1 to 4430.0	3831.1 Hours*micrograms per milliliter Interval 3087.7 to 4753.4	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90% CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=12 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Renal Clearance (CLr) of Gepotidacin	16.06 Liters per Hour Interval 14.18 to 18.18	17.59 Liters per Hour Interval 15.62 to 19.81	—	—

SECONDARY outcome

Timeframe: 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (0-2), n=14, 13	28.66 Milligrams Geometric Coefficient of Variation 185.9	NA Milligrams Geometric Coefficient of Variation NA NA indicates that data was not available as urine concentrations were below the lower limit of quantification. Hence, data was not calculated.	—	—
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (2-4), n=14, 12	89.18 Milligrams Geometric Coefficient of Variation 120.8	142.99 Milligrams Geometric Coefficient of Variation 42.7	—	—
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (4-6), n=14, 13	50.52 Milligrams Geometric Coefficient of Variation 119.1	82.77 Milligrams Geometric Coefficient of Variation 44.0	—	—
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (6-8); n=14, 13	34.38 Milligrams Geometric Coefficient of Variation 56.2	46.22 Milligrams Geometric Coefficient of Variation 55.3	—	—
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (8-12), n=12, 13	29.90 Milligrams Geometric Coefficient of Variation 38.3	30.97 Milligrams Geometric Coefficient of Variation 38.0	—	—
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (12-24), n=14, 13	25.44 Milligrams Geometric Coefficient of Variation 38.1	22.04 Milligrams Geometric Coefficient of Variation 121.3	—	—
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (24-36), n=14, 13	10.88 Milligrams Geometric Coefficient of Variation 43.1	8.76 Milligrams Geometric Coefficient of Variation 89.6	—	—
Cohort 1: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Ae (36-48), n=14, 13	4.50 Milligrams Geometric Coefficient of Variation 39.3	4.08 Milligrams Geometric Coefficient of Variation 88.5	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours Post-dose in each Treatment periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 percent (%).

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=12 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin	22.72 Percent dose excreted Geometric Coefficient of Variation 53.2	26.90 Percent dose excreted Geometric Coefficient of Variation 21.3	—	—

SECONDARY outcome

Timeframe: Up to 17 days

Population: Safety Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Number of Participants With SAE and Non-SAE Any SAE	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With SAE and Non-SAE Any non-SAE	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 17 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 %. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Normal or No Change	14 Participants	11 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To High	0 Participants	2 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Normal or No Change	13 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To High	1 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Low	0 Participants	2 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Normal or No Change	14 Participants	11 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Low	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Normal or No Change	13 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To High	1 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Normal or No Change	13 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To High	1 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Normal or No Change	14 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To High	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Normal or No Change	13 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To High	1 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Low	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Normal or No Change	13 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To High	1 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To High	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 17 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Normal or No Change	14 Participants	11 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To High	0 Participants	2 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Low	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Normal or No Change	14 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Normal or No Change	14 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To High	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Low	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	14 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Low	1 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Normal or No Change	13 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Normal or No Change	14 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To High	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Low	1 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Normal or No Change	13 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Normal or No Change	14 Participants	10 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To High	0 Participants	3 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Normal or No Change	14 Participants	12 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To High	0 Participants	1 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Normal or No Change	14 Participants	13 Participants	—	—

SECONDARY outcome

Timeframe: Up to 17 days

Population: Safety Population

Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Abnormal	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Abnormal	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Abnormal	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Normal or No Change	12 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Abnormal	2 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Abnormal	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Normal or No Change	13 Participants	11 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Abnormal	1 Participants	2 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Abnormal	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Normal or No Change	13 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To High	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 17 days

Population: Safety Population

Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal 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 normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To High	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Low	0 Participants	0 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 1: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To High	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 17 days

Population: Safety Population

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=14 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval QTcB Interval	3 Participants	4 Participants	—	—
Cohort 1: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval QTcF Interval	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: AUC(0-24) of Gepotidacin in Plasma	17.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 28.6	8.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 29.6	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: AUC(0-48) of Gepotidacin in Plasma	19.0 Hours*micrograms per milliliter Geometric Coefficient of Variation 27.7	9.5 Hours*micrograms per milliliter Geometric Coefficient of Variation 28.5	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: T1/2 of Gepotidacin in Plasma	10.882 Hours Geometric Coefficient of Variation 25.5	10.972 Hours Geometric Coefficient of Variation 17.2	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Vz/F of Gepotidacin in Plasma	1217.45 Liters Geometric Coefficient of Variation 37.0	2460.46 Liters Geometric Coefficient of Variation 39.2	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: CL/F of Gepotidacin in Plasma	77.55 Liters per Hour Geometric Coefficient of Variation 27.6	155.43 Liters per Hour Geometric Coefficient of Variation 27.9	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Ae Total of Gepotidacin in Urine	312.73 Milligrams Interval 286.95 to 340.82	156.05 Milligrams Interval 141.81 to 171.72	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: AUC(0-24) of Gepotidacin in Urine	3081.3 Hours*micrograms per milliliter Interval 2327.4 to 4079.5	1352.4 Hours*micrograms per milliliter Interval 1014.2 to 1803.4	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: AUC(0-48) of Gepotidacin in Urine	3370.1 Hours*micrograms per milliliter Interval 2571.4 to 4417.0	1476.8 Hours*micrograms per milliliter Interval 1119.2 to 1948.6	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: CLr of Gepotidacin	16.49 Liters per Hour Interval 15.02 to 18.09	17.07 Liters per Hour Interval 15.47 to 18.84	—	—

SECONDARY outcome

Timeframe: 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (0-2)	12.67 Milligrams Geometric Coefficient of Variation 567.5	NA Milligrams Geometric Coefficient of Variation NA NA indicates that data was not available as urine concentrations were below the lower limit of quantification. Hence, data was not calculated.	—	—
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (12-24)	21.17 Milligrams Geometric Coefficient of Variation 79.2	11.51 Milligrams Geometric Coefficient of Variation 36.4	—	—
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (24-36)	11.04 Milligrams Geometric Coefficient of Variation 77.9	4.74 Milligrams Geometric Coefficient of Variation 42.7	—	—
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (2-4)	79.84 Milligrams Geometric Coefficient of Variation 65.6	55.81 Milligrams Geometric Coefficient of Variation 47.4	—	—
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (4-6)	67.48 Milligrams Geometric Coefficient of Variation 44.3	21.66 Milligrams Geometric Coefficient of Variation 66.4	—	—
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (6-8)	33.92 Milligrams Geometric Coefficient of Variation 50.5	13.82 Milligrams Geometric Coefficient of Variation 56.1	—	—
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (8-12)	27.59 Milligrams Geometric Coefficient of Variation 63.1	9.19 Milligrams Geometric Coefficient of Variation 50.7	—	—
Cohort 2: Ae(t1-t2) of Gepotidacin Ae (36-48)	3.61 Milligrams Geometric Coefficient of Variation 90.3	2.75 Milligrams Geometric Coefficient of Variation 31.8	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin	20.85 Percent dose excreted Geometric Coefficient of Variation 16.9	10.42 Percent dose excreted Geometric Coefficient of Variation 25.4	—	—

SECONDARY outcome

Timeframe: Up to 26 days

Population: Safety Population. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=17 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted n=14 Participants Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Number of Participants With SAE and Non-SAE Any non-SAE	3 Participants	2 Participants	2 Participants	—
Cohort 2: Number of Participants With SAE and Non-SAE Any SAE	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to 26 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=17 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To High	0 Participants	1 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Normal or No Change	15 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To High	2 Participants	3 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Normal or No Change	14 Participants	15 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To High	3 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Low	0 Participants	1 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Normal or No Change	17 Participants	15 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To High	0 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Low	1 Participants	3 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Normal or No Change	15 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To High	1 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Low	0 Participants	4 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Normal or No Change	17 Participants	13 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To High	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to 26 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=17 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Normal or No Change	16 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To High	1 Participants	1 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To High	0 Participants	1 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Normal or No Change	16 Participants	15 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To High	1 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	17 Participants	15 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Normal or No Change	17 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Normal or No Change	17 Participants	15 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To High	0 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To High	0 Participants	1 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Low	0 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Low	0 Participants	3 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 2: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To High	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 26 days

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=16 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Abnormal	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Abnormal	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Normal or No Change	16 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Abnormal	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Abnormal	1 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Normal or No Change	17 Participants	15 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Abnormal	0 Participants	1 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Normal or No Change	17 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Abnormal	0 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Abnormal	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Normal or No Change	17 Participants	16 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Normal or No Change	14 Participants	15 Participants	—	—
Cohort 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To High	3 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to 26 days

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal 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 normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Normal or No Change	16 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To High	1 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Normal or No Change	17 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To High	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Low	0 Participants	0 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Normal or No Change	17 Participants	14 Participants	—	—
Cohort 2: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To High	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 26 days

Population: Safety Population. Only those participants with data available at specified time points were analyzed.

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=14 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval QTcB Interval	2 Participants	2 Participants	—	—
Cohort 2: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval QTcF Interval	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Cmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)	7.867 Micrograms per milliliter Geometric Coefficient of Variation 36.8	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Tmax of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)	2.500 Hours Interval 1.0 to 4.07	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)	0.250 Hours Interval 0.0 to 1.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-tau) of Gepotidacin in Plasma First Dose of 3000 mg (First Dose)	29.8 Hours*micrograms per milliliter Geometric Coefficient of Variation 30.8	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Cmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)	10.051 Micrograms per milliliter Geometric Coefficient of Variation 47.7	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Tmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)	2.000 Hours Interval 1.0 to 6.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-tau) of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)	41.9 Hours* micrograms per milliliter Geometric Coefficient of Variation 30.2	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as Cmax after the second dose divided by Cmax after the first dose.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: RoCmax of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)	1.278 Ratio Geometric Coefficient of Variation 54.4	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) after the second dose, where 0 is the timepoint prior to second dose, divided by AUC(0-tau) after the first dose, where 0 is the predose timepoint prior to the first dose.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: RoAUC of Gepotidacin in Plasma After the Second Dose of 3000 mg (Second Dose)	1.406 Ratio Geometric Coefficient of Variation 27.5	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-24) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)	73.2 Hours*micrograms per milliliter Geometric Coefficient of Variation 26.8	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-48) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)	81.2 Hours*micrograms per milliliter Geometric Coefficient of Variation 25.9	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-t) of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)	85.2 Hours*micrograms per milliliter Geometric Coefficient of Variation 20.1	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)	959.42 Liters Geometric Coefficient of Variation 30.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)	69.99 Liters per Hour Geometric Coefficient of Variation 20.1	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 Hours, 14 Hours, 14 Hours 30 Hours, 15, 16,18,20,24,36, 48, 60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose+ Second Dose)	9.501 Hours Geometric Coefficient of Variation 22.5	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Minimum Observed Concentration (Cmin) of Digoxin in Plasma	44.127 Picograms per milliliter Interval 34.943 to 55.723	77.447 Picograms per milliliter Interval 60.937 to 98.43	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: T1/2 of Digoxin in Plasma	39.367 Hours Interval 37.263 to 41.589	32.777 Hours Interval 30.975 to 34.683	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Vz/F of Digoxin in Plasma	923.75 Liters Interval 810.79 to 1052.46	688.49 Liters Interval 602.73 to 786.46	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 24 Hours, 36 Hours, 48 Hours, 72 Hours, 96 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of digoxin was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: CL/F of Digoxin in Plasma	16.26 Liters per Hour Interval 14.51 to 18.23	14.51 Liters per Hour Interval 12.91 to 16.31	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Cmin of Midazolam in Plasma	0.192 Nanograms per milliliter Interval 0.157 to 0.234	0.222 Nanograms per milliliter Interval 0.181 to 0.273	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: T1/2 of Midazolam in Plasma	5.320 Hours Interval 4.702 to 6.018	6.075 Hours Interval 5.358 to 6.887	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Vz/F of Midazolam in Plasma	615.36 Liters Interval 537.88 to 704.01	371.24 Liters Interval 323.51 to 426.01	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of midazolam was conducted using standard non-compartmental analysis. Analysis was performed using a linear mixed-effect model with treatment as a fixed effect and participant as a random effect. Geometric LS mean and 90 % CI of the geometric LS means have been presented.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: CL/F of Midazolam in Plasma	80.17 Liters per Hour Interval 67.66 to 94.99	42.16 Liters per Hour Interval 35.47 to 50.1	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose )	1066.21 Milligrams Geometric Coefficient of Variation 40.4	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (0-2), n=17	NA Milligrams Geometric Coefficient of Variation NA NA indicates that data was not available as urine concentrations were below the lower limit of quantification. Hence, data was not calculated.	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (2-4), n=18	117.61 Milligrams Geometric Coefficient of Variation 101.7	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (4-6), n=16	103.11 Milligrams Geometric Coefficient of Variation 57.3	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (6-8); n=16	70.98 Milligrams Geometric Coefficient of Variation 53.7	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (8-12), n=18	67.42 Milligrams Geometric Coefficient of Variation 44.3	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (12-14), n=17	64.49 Milligrams Geometric Coefficient of Variation 94.1	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (14-16), n=15	142.36 Milligrams Geometric Coefficient of Variation 142.3	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (16-18), n=14	146.89 Milligrams Geometric Coefficient of Variation 59.4	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (18-20), n=15	93.05 Milligrams Geometric Coefficient of Variation 83.5	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (20-24), n=17	74.44 Milligrams Geometric Coefficient of Variation 93.9	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (24-36), n=18	70.01 Milligrams Geometric Coefficient of Variation 105.0	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (36-48); n=18	20.16 Milligrams Geometric Coefficient of Variation 46.4	—	—	—
Cohort 3: Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose) Ae (48-60), n=18	8.51 Milligrams Geometric Coefficient of Variation 42.7	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose)	4770.8 Hours*micrograms per milliliter Geometric Coefficient of Variation 55.2	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose)	14333.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 59.2	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: AUC (0-48) of Gepotidacin in Urine Following Two 3000 mg Doses (First Dose + Second Dose)	16682.1 Hours*micrograms per milliliter Geometric Coefficient of Variation 59.4	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=18 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Percentage of the Given Dose of Drug Excreted in Urine (fe%) Following Two 3000 mg Doses of Gepotidacin (First Dose + Second Dose )	17.77 Percent dose excreted Geometric Coefficient of Variation 40.4	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=17 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: CLr of Gepotidacin Following Two 3000 mg Doses (First Dose + Second Dose)	13.19 Liters per Hour Geometric Coefficient of Variation 34.6	—	—	—

SECONDARY outcome

Timeframe: Up to 30 days

Population: Safety Population

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situations as per Medical or scientific judgment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Number of Participants With SAE and Non-SAE Any non-SAE	1 Participants	11 Participants	—	—
Cohort 3: Number of Participants With SAE and Non-SAE Any SAE	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 30 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of hematology parameters including Basophils, Eosinophils, MCH, MCV, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To High	0 Participants	2 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Basophils; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Eosinophils; To Normal or No Change	19 Participants	16 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCH; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To Normal or No Change	18 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline MCV; To High	1 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Low	2 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To Normal or No Change	17 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Erythrocytes; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Low	1 Participants	2 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To Normal or No Change	17 Participants	14 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hematocrit; To High	1 Participants	2 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Low	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To Normal or No Change	18 Participants	15 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Hemoglobin; To High	1 Participants	2 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To Normal or No Change	19 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocytes; To High	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To Normal or No Change	19 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Lymphocytes; To High	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Low	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To Normal or No Change	18 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Monocytes; To High	1 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To Normal or No Change	19 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Neutrophils; To High	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline Platelets; To High	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 30 days

Population: Safety Population

Blood samples were collected at indicated time points for analysis of clinical chemistry parameters including ALT, Albumin, Alk Phos, AST, Bilirubin, Calcium, Carbon Dioxide, Chloride, Creatine Kinase, Creatinine, Direct Bilirubin, Glucose, Magnesium, Potassium, Protein, Sodium, BUN. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To Normal or No Change	19 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline ALT; To High	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Low	1 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To Normal or No Change	18 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Albumin; To High	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Alk Phos; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To Normal or No Change	18 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline AST; To High	1 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Low	1 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To Normal or No Change	18 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Calcium; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Carbon Dioxide; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To Normal or No Change	19 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Chloride; To High	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To Normal or No Change	18 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatine Kinase; To High	1 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Creatinine; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Direct Bilirubin; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Magnesium; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To Normal or No Change	18 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Potassium; To High	1 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline Sodium; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Low	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To Normal or No Change	19 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline BUN; To High	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 30 days

Population: Safety Population

Urine samples were collected at indicated time points for the analysis of urinalysis parameters including pH of urine, presence of glucose, protein, blood, ketones, bilirubin, nitrite, leukocyte esterase in urine by dipstick. Specific gravity of urine was measured by microscopic examination. Participants were counted in the worst case category that their value changes to (low, normal, high, or abnormal), unless there is no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Abnormal	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Abnormal	5 Participants	5 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Abnormal	3 Participants	2 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Normal or No Change	13 Participants	13 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Leukocyte Esterase; To Abnormal	6 Participants	5 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Nitrite; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Occult Blood; To Normal or No Change	14 Participants	13 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Protein; To Normal or No Change	16 Participants	16 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline pH; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To Normal or No Chan	16 Participants	10 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Specific Gravity; To High	3 Participants	8 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Bilirubin; To Abnormal	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Glucose; To Abnormal	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Normal or No Change	16 Participants	17 Participants	—	—
Cohort 3: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Post-Baseline Relative to Baseline Ketones; To Abnormal	3 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Up to 30 days

Population: Safety Population

Vital signs including SBP, DBP and pulse rate were measured in a semi-supine position after 5 minutes rest. Participants were counted in the worst case category that their value changes to (low, normal 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 normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that participants had values flagged as high and low respectively for the particular parameter any time on-treatment.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline DBP; To High	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline SBP; To Normal or No Change	19 Participants	18 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Low	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants With Worst Case Vital Sign Results Relative to Normal Range Post-Baseline Relative to Baseline Pulse rate; To Normal or No Change	19 Participants	18 Participants	—	—

SECONDARY outcome

Timeframe: Up to 30 days

Population: Safety Population

A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes using an ECG machine that automatically calculated the QTc interval. Number of participants with any increase of \>450 milliseconds in corrected QT interval using the QTcB Interval and QTcF Interval has been reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=19 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=18 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval QTcB Interval	2 Participants	5 Participants	—	—
Cohort 3: Number of Participants With Any Increase in Maximum Post-Baseline ECG Parameter QTc Interval QTcF Interval	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: T1/2 of Gepotidacin Following Single Dose of 1500 mg in Plasma	12.848 Hours Geometric Coefficient of Variation 28.5	12.540 Hours Geometric Coefficient of Variation 14.2	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Vz/F of Gepotidacin Following Single Dose of 1500 mg in Plasma	1246.70 Liters Geometric Coefficient of Variation 38.8	1329.83 Liters Geometric Coefficient of Variation 17.7	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hour, 2 Hours 30 minutes, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours, 36 Hours, 48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=11 Participants Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: CL/F of Gepotidacin Following Single Dose of 1500 mg in Plasma	67.26 Liters per Hour Geometric Coefficient of Variation 15.5	73.50 Liters per Hour Geometric Coefficient of Variation 13.3	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Tlag of Gepotidacin in Plasma After the First Dose of 3000 mg (First Dose)-Fed State	0 Hours Interval 0.0 to 0.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=10 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Vz/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State	1251.05 Liters Geometric Coefficient of Variation 34.5	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=10 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: CL/F of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose)-Fed State	68.83 Liters per Hour Geometric Coefficient of Variation 13.9	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 30 minutes, 1 Hour, 1 Hour 30 minutes, 2 Hours, 2 Hours 30 minutes, 3, 4, 6, 8, 12 Hours, 12 Hours 30 minutes, 13 Hours, 13 Hours 30 minutes, 14 Hours, 14 Hours 30 minutes, 15, 16, 18, 20, 24, 36, 48, 60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Blood samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=10 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: T1/2 of Gepotidacin in Plasma Following Two 3000 mg Doses (First Dose + Second Dose )-Fed State	12.599 Hours Geometric Coefficient of Variation 36.6	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Ae Total of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine	293.50 Milligrams Geometric Coefficient of Variation 29.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (0-2)	NA Milligrams Geometric Coefficient of Variation NA NA indicates that data was not available as urine concentrations were below the lower limit of quantification. Hence, data was not calculated	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (2-4)	102.23 Milligrams Geometric Coefficient of Variation 25.2	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (4-6)	60.05 Milligrams Geometric Coefficient of Variation 57.0	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (6-8)	31.61 Milligrams Geometric Coefficient of Variation 48.9	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (8-12)	16.51 Milligrams Geometric Coefficient of Variation 97.0	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (12-24)	17.16 Milligrams Geometric Coefficient of Variation 49.3	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (24-36)	5.72 Milligrams Geometric Coefficient of Variation 196.5	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine Ae (36-48)	4.28 Milligrams Geometric Coefficient of Variation 63.2	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-24) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine	2142.4 Hours*micrograms per milliliter Geometric Coefficient of Variation 53.5	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-48) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine	2293.7 Hours*micrograms per milliliter Geometric Coefficient of Variation 53.2	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100%.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) for Gepotidacin 1500 mg Under Fed Condition	19.57 Percent dose excreted Geometric Coefficient of Variation 29.0	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: CLr of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition	13.42 Liters per Hour Geometric Coefficient of Variation 31.9	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae total was calculated by adding all the fractions of drug collected over all the allotted time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Ae Total of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State	1334.42 Milligrams Geometric Coefficient of Variation 25.4	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. Ae(t1-t2) measured the amount of drug excreted in urine at defined time intervals.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (0-2); n=11	NA Milligrams Geometric Coefficient of Variation NA NA indicates that data was not available as urine concentrations were below the lower limit of quantification. Hence, data was not calculated.	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (2-4); n=10	221.19 Milligrams Geometric Coefficient of Variation 56.7	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (4-6); n=11	103.68 Milligrams Geometric Coefficient of Variation 70.6	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (6-8); n=11	67.58 Milligrams Geometric Coefficient of Variation 49.5	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (8-12); n=11	65.06 Milligrams Geometric Coefficient of Variation 22.7	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (12-14); n=11	112.83 Milligrams Geometric Coefficient of Variation 66.3	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (14-16); n=11	174.62 Milligrams Geometric Coefficient of Variation 85.2	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (16-18); n=11	136.66 Milligrams Geometric Coefficient of Variation 68.1	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (18-20); n=11	90.81 Milligrams Geometric Coefficient of Variation 25.4	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (20-24); n=11	80.54 Milligrams Geometric Coefficient of Variation 20.4	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (24-36); n=11	57.62 Milligrams Geometric Coefficient of Variation 42.9	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (36-48); n=11	14.47 Milligrams Geometric Coefficient of Variation 36.9	—	—	—
Cohort 4: Ae(t1-t2) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State Ae (48-60); n=10	9.67 Milligrams Geometric Coefficient of Variation 61.7	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=10 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-tau) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State	4996.9 Hours*micrograms per milliliter Geometric Coefficient of Variation 64.4	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=10 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-24) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State	14729.5 Hours*micrograms per milliliter Geometric Coefficient of Variation 59.3	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time points were analyzed.

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=10 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-48) of Gepotidacin in Urine Following Two 3000 mg Doses-Fed State	15768.2 Hours*micrograms per milliliter Geometric Coefficient of Variation 58.8	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis. fe% was calculated as: (Ae total divided by Dose) multiplied by 100 %.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin Following Two 3000 mg Doses-Fed State	22.24 Percent dose excreted Geometric Coefficient of Variation 25.4	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-14 Hours, 14-16 Hours, 16-18 Hours, 18-20 Hours, 20-24 Hours, 24-36 Hours, 36-48 Hours, 48-60 Hours post-dose in Treatment Period 3

Population: Pharmacokinetic Parameter Population

Urine samples were collected at indicated time points. Pharmacokinetic analysis of gepotidacin was conducted using standard non-compartmental analysis.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: CLr of Gepotidacin Following Two 3000 mg Dose-Fed State	14.61 Liters per Hour Geometric Coefficient of Variation 19.3	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-dose, 0-2 Hours, 2-4 Hours, 4-6 Hours, 6-8 Hours, 8-12 Hours, 12-24 Hours, 24-36 Hours, 36-48 Hours post-dose in each Treatment Periods 1 and 2

Population: Pharmacokinetic Parameter Population. This was an other pre-specified outcome measure. The results for this outcome measure will never be posted.

Urine samples were collected at indicated time points. AUC(0-tau) can be calculated only for multiple doses and not for single dose as tau refers to the dosing interval. Hence, AUC(0-tau) could not be calculated for Gepotidacin 1500 mg single dose as mentioned in Reporting and Analysis Plan. The results for this outcome measure will never be posted.

Outcome measures

Outcome measures
Measure	Cohort 1: Gepotidacin 1500 mg n=11 Participants Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 4: Gepotidacin 1500 mg Fasted Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Cohort 4: AUC(0-tau) of Gepotidacin Following Single Dose of 1500 mg Under Fed Condition in Urine	NA Hours*micrograms per milliliter Geometric Coefficient of Variation NA NA indicates that data was not available as AUC(0-tau) could not be calculated for single dose as it can be calculated only for multiple doses.	—	—	—

Adverse Events

Cohort 1: Gepotidacin 1500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2: Period 1: Gepotidacin 1500 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2: Period 2 (Days 1 to 7) Rifampicin 600 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: Period 2 (Days 8 to 9) Gepotidacin 1500 mg + Rifampicin 600 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 3: Digoxin 0.5 mg + Midazolam 2 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3:Gepotidacin 3000 mg + Digoxin 0.5 mg + Midazolam 2 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort 4: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 4: Gepotidacin 1500 mg Fed

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 4: Gepotidacin 1500 mg Fasted

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 4: Gepotidacin 3000 mg Fed

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1: Gepotidacin 1500 mg n=14 participants at risk Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 1.	Cohort 1: Gepotidacin 1500 mg + Cimetidine 400 mg n=13 participants at risk Participants received cimetidine 400 mg 4 times daily on Days 1 through 4 of Period 2 along with a single dose of gepotidacin 1500 mg administered one hour after the first dose of cimetidine on Day 2 of Period 2 in Cohort 1.	Cohort 2: Period 1: Gepotidacin 1500 mg n=17 participants at risk Participants received a single oral dose of gepotidacin 1500 mg on Day 1 of Period 1 in Cohort 2.	Cohort 2: Period 2 (Days 1 to 7) Rifampicin 600 mg n=17 participants at risk Participants received rifampicin 600 mg (administered in the evenings) once daily for 7 days (Days 1 through 7) of Period 2 in Cohort 2.	Cohort 2: Period 2 (Days 8 to 9) Gepotidacin 1500 mg + Rifampicin 600 mg n=14 participants at risk Participants received a single dose of gepotidacin 1500 mg administered in the morning on Day 8 and rifampicin 600 mg administered in the evening on Days 8 and 9 of Period 2 in Cohort 2.	Cohort 3: Digoxin 0.5 mg + Midazolam 2 mg n=19 participants at risk Participants received digoxin 0.5 mg and midazolam 2 mg on Day 1 of Period 1 and Period 2 in Cohort 3.	Cohort 3:Gepotidacin 3000 mg + Digoxin 0.5 mg + Midazolam 2 mg n=18 participants at risk Participants received two doses of gepotidacin 3000 mg given 12 hours apart along with co-administration of digoxin 0.5 mg and midazolam 2 mg with the second dose of gepotidacin on Day 1 of Period 1 and Period 2 in Cohort 3.	Cohort 4: Placebo n=3 participants at risk Japanese participants received a single oral dose of placebo matching gepotidacin under fed conditions in Period 1 or a single dose of placebo matching gepotidacin under fasted conditions in Period 2 or two doses of placebo (given 12 hours apart) matching gepotidacin under fed conditions in Period 3 in Cohort 4.	Cohort 4: Gepotidacin 1500 mg Fed n=11 participants at risk Japanese participants received a single dose of gepotidacin 1500 mg under fed conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 1500 mg Fasted n=11 participants at risk Japanese participants received a single dose of gepotidacin 1500 mg under fasted conditions on Day 1 of Period 1 and Period 2 in Cohort 4.	Cohort 4: Gepotidacin 3000 mg Fed n=11 participants at risk Japanese participants received two doses of gepotidacin 3000 mg (given 12 hours apart) under fed conditions on on Day 1 of Period 3 in Cohort 4.
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/13 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	11.8% 2/17 • Number of events 2 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/17 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	14.3% 2/14 • Number of events 2 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/19 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	33.3% 6/18 • Number of events 6 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/3 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	27.3% 3/11 • Number of events 3 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.
Gastrointestinal disorders Nausea	0.00% 0/14 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/13 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	5.9% 1/17 • Number of events 1 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	11.8% 2/17 • Number of events 2 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/14 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/19 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	22.2% 4/18 • Number of events 4 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/3 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	9.1% 1/11 • Number of events 1 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	18.2% 2/11 • Number of events 2 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	18.2% 2/11 • Number of events 2 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.
Nervous system disorders Headache	0.00% 0/14 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/13 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	11.8% 2/17 • Number of events 2 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	5.9% 1/17 • Number of events 1 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/14 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/19 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/18 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/3 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.
Investigations Electrocardiogram T wave abnormal	0.00% 0/14 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/13 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/17 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/17 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/14 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	5.3% 1/19 • Number of events 1 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	11.1% 2/18 • Number of events 2 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/3 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.	0.00% 0/11 • Serious adverse events (SAE) and non-serious adverse events (non-SAE) were collected up to 17 days during Cohort 1; up to 26 days during Cohort 2; up to 30 days during Cohort 3 and up to 22 days during Cohort 4. Safety Population comprised of all participants who took at least 1 dose of study intervention. Participants with adverse events that occurred during Days 1 to 7 in Period 2 after the exposure of Rifampicin 600 mg and those occurred during Days 8 to 9 in Period 2 after exposure of Gepotidacin 1500 mg + Rifampicin 600 mg were summarized separately. Only those participants with data available at specified time points were analyzed.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER