Trial Outcomes & Findings for A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea (NCT NCT04010539)

Last Updated: 2024-05-30

Results Overview

Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

628 participants

Primary outcome timeframe

Baseline (Day 1) and TOC visit (Day 4 to 8)

Results posted on

2024-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Gepotidacin Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Overall Study STARTED	314	314
Overall Study Safety Population	309	313
Overall Study Microbiological ITT (Micro-ITT) Population	202	204
Overall Study Micro-ITT Rectal Population	26	15
Overall Study Micro-ITT Pharyngeal Population	18	17
Overall Study COMPLETED	294	295
Overall Study NOT COMPLETED	20	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Gepotidacin Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Overall Study Withdrawal by Subject	4	1
Overall Study Physician Decision	0	2
Overall Study Lost to Follow-up	10	14
Overall Study Adverse Event	3	0
Overall Study Participant Did Not Receive IP	0	1
Overall Study Protocol Deviation	0	1
Overall Study Randomized in Error/ Mistake	2	0
Overall Study Eligibility Criteria Unable to Evaluate	1	0

Baseline Characteristics

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gepotidacin n=314 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=314 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.	Total n=628 Participants Total of all reporting groups
Age, Continuous	33.9 Years STANDARD_DEVIATION 10.42 • n=5 Participants	33.7 Years STANDARD_DEVIATION 10.70 • n=7 Participants	33.8 Years STANDARD_DEVIATION 10.56 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	279 Participants n=5 Participants	280 Participants n=7 Participants	559 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants	39 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) White	231 Participants n=5 Participants	241 Participants n=7 Participants	472 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Microbiological intent-to-treat (Micro-ITT) population included all participants randomly assigned to study treatment who received at least 1 dose of study treatment and have confirmed NG isolated that is ceftriaxone-susceptible (based on CLSI breakpoints) from baseline culture of their urogenital specimen.

Outcome measures

Outcome measures
Measure	Gepotidacin n=202 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=204 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) Microbiological success	187 Participants	186 Participants
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) Microbiological failure, BP	0 Participants	0 Participants
Number of Participants With Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) Microbiological failure, UTD	15 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Micro-ITT Rectal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their rectal specimen.

Rectal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.

Outcome measures

Outcome measures
Measure	Gepotidacin n=26 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=15 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit Microbiological success	26 Participants	12 Participants
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit Microbiological failure, BP	0 Participants	0 Participants
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit Microbiological failure, UTD	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Micro-ITT Pharyngeal population included all participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their pharyngeal specimen.

Pharyngeal specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD)" outcomes. Bacterial persistence was defined as culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD was defined as inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or the participant received other systemic antimicrobials before the TOC visit.

Outcome measures

Outcome measures
Measure	Gepotidacin n=18 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=17 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit Microbiological success	14 Participants	16 Participants
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit Microbiological failure, BP	2 Participants	0 Participants
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit Microbiological failure, UTD	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 21 days

Population: Safety population included all participants who received at least 1 dose of study treatment.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Gepotidacin n=309 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=313 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) Any TEAEs	230 Participants	104 Participants
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs) Any SAEs	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=284 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=293 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) MCHC, Baseline (Day 1)	318.5 Grams per liter (g/L) Standard Deviation 16.27	318.8 Grams per liter (g/L) Standard Deviation 16.12
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) MCHC, CFB to TOC	2.4 Grams per liter (g/L) Standard Deviation 10.67	0.3 Grams per liter (g/L) Standard Deviation 11.27
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) Hb, Baseline (Day 1)	149.1 Grams per liter (g/L) Standard Deviation 12.83	149.2 Grams per liter (g/L) Standard Deviation 12.58
Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) Hb, CFB to TOC	0.00 Grams per liter (g/L) Standard Deviation 6.70	0.6 Grams per liter (g/L) Standard Deviation 6.92

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=284 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=293 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Hematology Parameter: Hematocrit Baseline (Day 1)	0.4691 Percentage Standard Deviation 0.04205	0.4687 Percentage Standard Deviation 0.04104
Change From Baseline in Hematology Parameter: Hematocrit CFB to TOC	-0.0038 Percentage Standard Deviation 0.02526	0.0012 Percentage Standard Deviation 0.02666

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=284 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=293 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Hematology Parameter: Erythrocytes Baseline (Day 1)	4.911 Trillion cells per liter (10^12 cells/L) Standard Deviation 0.4722	4.926 Trillion cells per liter (10^12 cells/L) Standard Deviation 0.4601
Change From Baseline in Hematology Parameter: Erythrocytes CFB to TOC	0.003 Trillion cells per liter (10^12 cells/L) Standard Deviation 0.2261	0.019 Trillion cells per liter (10^12 cells/L) Standard Deviation 0.2332

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=284 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=293 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) Baseline (Day 1)	30.46 Picograms (pg) Standard Deviation 1.978	30.38 Picograms (pg) Standard Deviation 1.987
Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) CFB to TOC	-0.03 Picograms (pg) Standard Deviation 0.451	0.00 Picograms (pg) Standard Deviation 0.594

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=284 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=293 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) Baseline (Day 1)	95.79 Femtoliters (fL) Standard Deviation 6.266	95.43 Femtoliters (fL) Standard Deviation 6.760
Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) CFB to TOC	-0.85 Femtoliters (fL) Standard Deviation 3.104	-0.12 Femtoliters (fL) Standard Deviation 3.084

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: urea nitrogen (UN), glucose, calcium, chloride, sodium, magnesium and potassium. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=304 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=306 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Sodium, Baseline (Day 1)	139.6 Millimoles per liter (mmol/L) Standard Deviation 2.11	139.6 Millimoles per liter (mmol/L) Standard Deviation 2.02
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Sodium, CFB to TOC	0.2 Millimoles per liter (mmol/L) Standard Deviation 2.19	0.1 Millimoles per liter (mmol/L) Standard Deviation 2.44
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Magnesium, Baseline (Day 1)	0.854 Millimoles per liter (mmol/L) Standard Deviation 0.0612	0.855 Millimoles per liter (mmol/L) Standard Deviation 0.0637
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Magnesium, CFB to TOC	-0.003 Millimoles per liter (mmol/L) Standard Deviation 0.0604	-0.004 Millimoles per liter (mmol/L) Standard Deviation 0.0584
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Potassium, Baseline (Day 1)	4.29 Millimoles per liter (mmol/L) Standard Deviation 0.323	4.30 Millimoles per liter (mmol/L) Standard Deviation 0.332
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Potassium, CFB to TOC	-0.04 Millimoles per liter (mmol/L) Standard Deviation 0.336	-0.03 Millimoles per liter (mmol/L) Standard Deviation 0.345
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium UN, Baseline (Day 1)	4.793 Millimoles per liter (mmol/L) Standard Deviation 1.4293	4.800 Millimoles per liter (mmol/L) Standard Deviation 1.4669
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium UN, CFB to TOC	0.190 Millimoles per liter (mmol/L) Standard Deviation 1.1640	0.282 Millimoles per liter (mmol/L) Standard Deviation 1.1920
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Glucose, Baseline	5.049 Millimoles per liter (mmol/L) Standard Deviation 1.0557	5.090 Millimoles per liter (mmol/L) Standard Deviation 1.1183
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Glucose, CFB to TOC	0.227 Millimoles per liter (mmol/L) Standard Deviation 0.9425	0.064 Millimoles per liter (mmol/L) Standard Deviation 0.9684
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Calcium, Baseline (Day 1)	2.387 Millimoles per liter (mmol/L) Standard Deviation 0.0986	2.387 Millimoles per liter (mmol/L) Standard Deviation 0.0954
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Calcium, CFB to TOC	-0.009 Millimoles per liter (mmol/L) Standard Deviation 0.0852	-0.015 Millimoles per liter (mmol/L) Standard Deviation 0.0871
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Chloride, Baseline (Day 1)	101.7 Millimoles per liter (mmol/L) Standard Deviation 2.26	101.7 Millimoles per liter (mmol/L) Standard Deviation 2.30
Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium Chloride, CFB to TOC	0.7 Millimoles per liter (mmol/L) Standard Deviation 2.57	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.40

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: bilirubin, direct bilirubin and creatinine levels. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=303 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=305 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Baseline (Day 1)	8.54 Micromoles per liter (umol/L) Standard Deviation 5.861	7.71 Micromoles per liter (umol/L) Standard Deviation 4.806
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, CFB to TOC	-0.05 Micromoles per liter (umol/L) Standard Deviation 5.025	-0.14 Micromoles per liter (umol/L) Standard Deviation 3.914
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine Direct Bilirubin, Baseline (Day 1)	3.83 Micromoles per liter (umol/L) Standard Deviation 1.248	3.76 Micromoles per liter (umol/L) Standard Deviation 1.210
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine Direct Bilirubin, CFB to TOC	-0.02 Micromoles per liter (umol/L) Standard Deviation 0.897	0.01 Micromoles per liter (umol/L) Standard Deviation 0.876
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Baseline (Day 1)	75.9 Micromoles per liter (umol/L) Standard Deviation 34.12	75.0 Micromoles per liter (umol/L) Standard Deviation 20.63
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine Creatinine, CFB to TOC	-0.2 Micromoles per liter (umol/L) Standard Deviation 34.08	2.6 Micromoles per liter (umol/L) Standard Deviation 9.52

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: albumin and protein. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=305 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=306 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Albumin, CFB to TOC	-0.3 Grams per liter (g/L) Standard Deviation 2.35	-0.3 Grams per liter (g/L) Standard Deviation 2.67
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Albumin, Baseline (Day 1)	46.9 Grams per liter (g/L) Standard Deviation 3.12	46.8 Grams per liter (g/L) Standard Deviation 3.19
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Protein, Baseline (Day 1)	73.1 Grams per liter (g/L) Standard Deviation 4.80	73.3 Grams per liter (g/L) Standard Deviation 4.85
Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein Protein, CFB to TOC	-0.5 Grams per liter (g/L) Standard Deviation 3.86	-0.5 Grams per liter (g/L) Standard Deviation 4.02

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=303 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=305 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) ALP, CFB to TOC	-0.4 International units per Liter (IU/L) Standard Deviation 7.73	-1.5 International units per Liter (IU/L) Standard Deviation 7.80
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) ALT, CFB to TOC	1.4 International units per Liter (IU/L) Standard Deviation 12.59	1.1 International units per Liter (IU/L) Standard Deviation 7.64
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) ALP, Baseline (Day 1)	76.0 International units per Liter (IU/L) Standard Deviation 20.86	77.1 International units per Liter (IU/L) Standard Deviation 26.53
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) AST, Baseline (Day 1)	24.4 International units per Liter (IU/L) Standard Deviation 15.30	24.2 International units per Liter (IU/L) Standard Deviation 16.29
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) AST, CFB to TOC	2.8 International units per Liter (IU/L) Standard Deviation 19.51	0.9 International units per Liter (IU/L) Standard Deviation 13.25
Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) ALT, Baseline (Day 1)	23.7 International units per Liter (IU/L) Standard Deviation 18.78	23.7 International units per Liter (IU/L) Standard Deviation 14.35

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected for urinalysis: Glucose, Protein, Occult Blood and Ketones. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Small, Moderate, Large, Positive, 5 milligram per deciliter (mg/dL), 20 mg/dL, 30 mg/dL 50 mg/dL, 100 mg/dL, 150 mg/dL and \>=500 mg/dL indicating concentrations in the urine sample. In the row title (Glucose, Baseline, Negative), Glucose indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=299 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=307 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Number of Participants With Urinalysis Dipstick Results Glucose, Baseline (Day 1), Negative	296 Participants	305 Participants
Number of Participants With Urinalysis Dipstick Results Glucose, Baseline (Day 1), 150 mg/dL	0 Participants	0 Participants
Number of Participants With Urinalysis Dipstick Results Glucose, Baseline (Day 1), >=500 mg/dL	3 Participants	2 Participants
Number of Participants With Urinalysis Dipstick Results Glucose, TOC, Negative	284 Participants	283 Participants
Number of Participants With Urinalysis Dipstick Results Glucose, TOC, 150 mg/dL	1 Participants	1 Participants
Number of Participants With Urinalysis Dipstick Results Glucose, TOC, >=500 mg/dL	2 Participants	1 Participants
Number of Participants With Urinalysis Dipstick Results Ketones, Baseline (Day 1), Negative	288 Participants	300 Participants
Number of Participants With Urinalysis Dipstick Results Ketones, Baseline (Day 1), 5 mg/dL	10 Participants	7 Participants
Number of Participants With Urinalysis Dipstick Results Ketones, Baseline (Day 1), 20 mg/dL	1 Participants	0 Participants
Number of Participants With Urinalysis Dipstick Results Ketones, TOC, Negative	279 Participants	279 Participants
Number of Participants With Urinalysis Dipstick Results Ketones, TOC, 5 mg/dL	7 Participants	6 Participants
Number of Participants With Urinalysis Dipstick Results Ketones, TOC, 20 mg/dL	1 Participants	0 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, Baseline (Day 1), Negative	202 Participants	192 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, Baseline (Day 1), Small	77 Participants	91 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, Baseline (Day 1), Moderate	18 Participants	19 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, Baseline (Day 1), Large	2 Participants	5 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, TOC, Negative	251 Participants	252 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, TOC, Small	30 Participants	24 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, TOC, Moderate	3 Participants	6 Participants
Number of Participants With Urinalysis Dipstick Results Occult Blood, TOC, Large	3 Participants	3 Participants
Number of Participants With Urinalysis Dipstick Results Protein, Baseline (Day 1), Negative	212 Participants	210 Participants
Number of Participants With Urinalysis Dipstick Results Protein, Baseline (Day 1), 30 mg/dL	79 Participants	83 Participants
Number of Participants With Urinalysis Dipstick Results Protein, Baseline (Day 1), 100 mg/dL	8 Participants	13 Participants
Number of Participants With Urinalysis Dipstick Results Protein, Baseline (Day 1), >=500 mg/dL	0 Participants	1 Participants
Number of Participants With Urinalysis Dipstick Results Protein, TOC, Negative	239 Participants	244 Participants
Number of Participants With Urinalysis Dipstick Results Protein, TOC, 30 mg/dL	46 Participants	37 Participants
Number of Participants With Urinalysis Dipstick Results Protein, TOC, 100 mg/dL	2 Participants	4 Participants
Number of Participants With Urinalysis Dipstick Results Protein, TOC, >=500 mg/dL	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected from participants to assess urine specific gravity. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=299 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=307 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Absolute Values in Specific Gravity of Urine Baseline (Day 1)	1.0211 Ratio Standard Deviation 0.00750	1.0207 Ratio Standard Deviation 0.00747
Absolute Values in Specific Gravity of Urine TOC	1.0211 Ratio Standard Deviation 0.00720	1.0216 Ratio Standard Deviation 0.00748

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Urine samples were collected from participants to assess urine pH. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=299 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=307 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Absolute Values in Potential of Hydrogen (pH) of Urine Baseline (Day 1)	5.6 pH Standard Deviation 0.69	5.6 pH Standard Deviation 0.70
Absolute Values in Potential of Hydrogen (pH) of Urine TOC	5.5 pH Standard Deviation 0.64	5.4 pH Standard Deviation 0.62

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=307 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=313 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Baseline (Day 1)	123.9 Millimeters of mercury (mmHg) Standard Deviation 13.69	125.1 Millimeters of mercury (mmHg) Standard Deviation 14.41
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, CFB to TOC	-0.4 Millimeters of mercury (mmHg) Standard Deviation 12.61	-0.5 Millimeters of mercury (mmHg) Standard Deviation 12.86
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Baseline (Day 1)	76.7 Millimeters of mercury (mmHg) Standard Deviation 10.77	77.2 Millimeters of mercury (mmHg) Standard Deviation 10.50
Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, CFB to TOC	0.1 Millimeters of mercury (mmHg) Standard Deviation 9.10	-0.9 Millimeters of mercury (mmHg) Standard Deviation 9.54

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=308 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=313 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Vital Sign: Pulse Rate Baseline (Day 1)	73.0 Beats per minute Standard Deviation 12.24	72.8 Beats per minute Standard Deviation 12.20
Change From Baseline in Vital Sign: Pulse Rate CFB to TOC	2.2 Beats per minute Standard Deviation 12.44	2.4 Beats per minute Standard Deviation 12.33

SECONDARY outcome

Timeframe: Baseline (Day 1) and TOC visit (Day 4 to 8)

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Temperature was measured after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

Outcome measures

Outcome measures
Measure	Gepotidacin n=306 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=313 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline in Vital Sign: Temperature CFB to TOC	-0.03 Celsius (C) Standard Deviation 0.381	-0.06 Celsius (C) Standard Deviation 0.485
Change From Baseline in Vital Sign: Temperature Baseline (Day 1)	36.45 Celsius (C) Standard Deviation 0.395	36.44 Celsius (C) Standard Deviation 0.457

Adverse Events

Gepotidacin

Serious events: 1 serious events

Other events: 230 other events

Deaths: 0 deaths

Ceftriaxone Plus Azithromycin

Serious events: 0 serious events

Other events: 81 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gepotidacin n=309 participants at risk Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=313 participants at risk Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Injury, poisoning and procedural complications Lower limb fracture	0.32% 1/309 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.00% 0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.

Other adverse events

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

Measure	Gepotidacin n=284 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=293 Participants Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Basophils, Baseline (Day 1)	0.044 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0196	0.045 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0222
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Basophils, CFB to TOC	0.001 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0167	0.000 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0152
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Eosinophils, Baseline (Day 1)	0.154 Giga cells per liter (10^9 cells/L) Standard Deviation 0.2117	0.160 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1384
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Eosinophils, CFB to TOC	0.009 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1289	0.018 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0827
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Leukocytes, Baseline (Day 1)	7.143 Giga cells per liter (10^9 cells/L) Standard Deviation 2.2808	7.507 Giga cells per liter (10^9 cells/L) Standard Deviation 2.2045
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Leukocytes, CFB to TOC	-0.811 Giga cells per liter (10^9 cells/L) Standard Deviation 1.8536	-1.267 Giga cells per liter (10^9 cells/L) Standard Deviation 1.9362
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Neutrophils, Baseline (Day 1)	4.443 Giga cells per liter (10^9 cells/L) Standard Deviation 1.9621	4.774 Giga cells per liter (10^9 cells/L) Standard Deviation 1.9355
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Neutrophils, CFB to TOC	-1.062 Giga cells per liter (10^9 cells/L) Standard Deviation 1.7309	-1.473 Giga cells per liter (10^9 cells/L) Standard Deviation 1.8860
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Platelets, Baseline (Day 1)	260.3 Giga cells per liter (10^9 cells/L) Standard Deviation 61.79	268.4 Giga cells per liter (10^9 cells/L) Standard Deviation 69.26
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Platelets, CFB to TOC	10.2 Giga cells per liter (10^9 cells/L) Standard Deviation 32.14	9.7 Giga cells per liter (10^9 cells/L) Standard Deviation 34.94
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Lymphocytes, Baseline (Day 1)	1.934 Giga cells per liter (10^9 cells/L) Standard Deviation 0.5941	1.948 Giga cells per liter (10^9 cells/L) Standard Deviation 0.6321
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Lymphocytes, CFB to TOC	0.277 Giga cells per liter (10^9 cells/L) Standard Deviation 0.5205	0.245 Giga cells per liter (10^9 cells/L) Standard Deviation 0.5511
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Monocytes, Baseline (Day 1)	0.559 Giga cells per liter (10^9 cells/L) Standard Deviation 0.2209	0.572 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1877
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Monocytes, CFB to TOC	-0.034 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1917	-0.053 Giga cells per liter (10^9 cells/L) Standard Deviation 0.1782
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Nucleated Erythrocytes, Baseline (Day 1)	0.002 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0047	0.001 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0038
Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes Nucleated Erythrocytes, CFB to TOC	0.000 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0070	0.001 Giga cells per liter (10^9 cells/L) Standard Deviation 0.0059

Measure	Gepotidacin n=309 participants at risk Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4\750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4\750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	Ceftriaxone Plus Azithromycin n=313 participants at risk Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2\*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
Gastrointestinal disorders Diarrhoea	48.9% 151/309 • Number of events 167 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	9.6% 30/313 • Number of events 30 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Nausea	23.6% 73/309 • Number of events 80 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	2.9% 9/313 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Vomiting	6.5% 20/309 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.64% 2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Flatulence	6.5% 20/309 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.32% 1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal Pain	5.2% 16/309 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.96% 3/313 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Faeces soft	5.2% 16/309 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.32% 1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal distension	1.6% 5/309 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.64% 2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	1.9% 6/309 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.32% 1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Gastrointestinal disorders Abdominal discomfort	1.3% 4/309 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.64% 2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations Chlamydial infection	3.9% 12/309 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	3.2% 10/313 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations Urethritis chlamydial	1.9% 6/309 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.00% 0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations Proctitis chlamydial	1.3% 4/309 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.32% 1/313 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/309 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	1.3% 4/313 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders Dizziness	5.2% 16/309 • Number of events 19 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.64% 2/313 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Nervous system disorders Headache	3.2% 10/309 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	2.6% 8/313 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
General disorders Fatigue	2.6% 8/309 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.00% 0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
General disorders Injection site pain	0.00% 0/309 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	1.6% 5/313 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.3% 7/309 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.00% 0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.
Eye disorders Vision blurred	1.9% 6/309 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.	0.00% 0/313 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days). Safety population included all participants who received at least 1 dose of study treatment.