A Study Evaluating Efficacy and Safety of Gepotidacin Com... | NCT04010539

NCT04010539

ID	Type	Description	Link
2018-001780-23	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants receiving Gepotidacin	Experimental	Participants will receive Gepotidacin orally at the study site during the Baseline (Day 1) visit followed by self-administration of a second oral dose as an outpatient 10 to 12 hours after the first dose.	Drug: Gepotidacin
Participants receiving Ceftriaxone plus Azithromycin	Active Comparator	Participants will receive a single IM dose of Ceftriaxone plus a single oral dose of Azithromycin at the study site during the Baseline (Day 1) visit.	Drug: Ceftriaxone Drug: Azithromycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gepotidacin	Drug	Gepotidacin will be administered as 3000 milligram (mg) oral dose (4 X 750 mg tablets) at the study site followed by 3000 mg oral dose (4 X 750 mg tablets) as an outpatient. Each dose should be taken after food consumption and with water.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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.	Baseline (Day 1) and TOC visit (Day 4 to 8)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must be >=12 years of age at the time of signing the informed consent.
Participants having body weight of >45 kilogram (kg).
Participants having clinical suspicion of a urogenital gonococcal infection with or without pharyngeal and/or rectal gonococcal infection and have one of the following: male participants with purulent yellow, green, or white urethral discharge or female participants with abnormal cervical or vaginal mucopurulent discharge upon physical examination; or a prior positive culture for N. gonorrhoeae from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a Gram or equivalent stain (urogenital specimens only) positive or presumptive for Gram-negative intracellular diplococci from up to 5 days before screening (as long as the participant has not received any treatment for this infection); or a prior positive nucleic acid amplification test assay for N. gonorrhoeae from up to 7 days before screening (as long as the participant has not received any treatment for this infection).
Participants who are willing to avoid anal, oral, and vaginal sexual intercourse or use condoms for all forms of intercourse from the Baseline Visit through the TOC Visit.
Male or female participants having his or her original urogenital anatomy at birth.
Male participant must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.
Female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance (male partners of WOCBP must use a male condom during intercourse) from the Baseline Visit through completion of the TOC Visit.
Participants who are capable of giving signed informed consent or assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) or assent form and in study protocol.

Exclusion Criteria:

Male participants with a current diagnosis of epididymitis and/or orchitis at the time of the Baseline Visit.
Participant who is suspected or confirmed to have a Chlamydia trachomatis infection and per the investigator's judgement standard-of-care treatment for this infection cannot be safely postponed until the TOC Visit.
Participant has a body mass index >=40 kilogram per square meter (kg/m^2) or has a body mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditions such as high blood pressure or diabetes.
Participant has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation.
Participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
Participants with a known cluster of differentiation 4 (CD4) count of <200 cells per cubic millimeter (cells/mm^3).
Participant has any of the following: poorly controlled asthma or chronic obstructive pulmonary disease, acute severe pain, uncontrolled with conventional medical management, active peptic ulcer disease, Parkinson disease, Myasthenia gravis, a history of seizure disorder requiring medications for control or participant has any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment.
Participant has known anuria, oliguria, or severe impairment of renal function (creatinine clearance <30 milliliter per minute [mL/min] or clinically significant elevated serum creatinine as determined by the investigator).
Participant in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
Participant has a serious underlying disease that could be imminently life threatening, or the participant is unlikely to survive for the duration of the study period.
Participant has congenital long QT syndrome or known prolongation of corrected QT interval (QTc).
Participant has uncompensated heart failure.
Participant has severe left ventricular hypertrophy.
Participant has a family history of QT prolongation or sudden death.
Participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or bradyarrhythmia within the last 12 months.
The participant is taking QT-prolonging drugs or drugs known to increase the risk of torsades de pointes (TdP) per the www.crediblemeds.org "Known Risk of TdP" category at the time of his or her Baseline Visit, which cannot be safely discontinued from the Baseline Visit to the TOC Visit; or the participant is taking a strong cytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp) inhibitor.
For any participant >=12 to <18 years, the participant has an abnormal electrocardiogram (ECG) reading.
The participant has a QTc >450 millisecond (msec) or a QTc >480 msec for participants with bundle-branch block.
Participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
Participant has a known history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin.
Participant has a known alanine aminotransferase (ALT) value >2 times upper limit of normal (ULN).
Participant has a known bilirubin value >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Participant has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), including symptomatic viral hepatitis or moderate-to-severe liver insufficiency (Child Pugh class B or C).
Participant has been previously randomized in this study or has previously been treated with Gepotidacin.
Participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
Participant has any of the following gonococcal infections that require a different dose or duration of treatment: suspected or confirmed pelvic inflammatory disease; or suspected or confirmed gonococcal arthritis; or suspected or confirmed gonococcal conjunctivitis; or suspected or confirmed gonococcal endocarditis; or other evidence of disseminated gonococcal infection.
Participant has received any antibacterial therapy for the treatment of a gonococcal infection within 14 days before the Baseline Visit.
Participant has received any systemic, topical, or intravaginal antibiotics or any systemic antifungals within 7 days before the Baseline Visit.
Participant must not use St John's wort or ergot derivatives from within 14 days before the Baseline Visit through the TOC Visit.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Los Angeles	California	90036	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40245902	Derived	Ross JDC, Wilson J, Workowski KA, Taylor SN, Lewis DA, Gatsi S, Flight W, Scangarella-Oman NE, Jakielaszek C, Lythgoe D, Powell M, Janmohamed S, Absalon J, Perry C. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. Lancet. 2025 May 3;405(10489):1608-1620. doi: 10.1016/S0140-6736(25)00628-2. Epub 2025 Apr 14.
37751016

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 10, 2023	May 1, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Participants receiving Gepotidacin

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00033.9± 10.42 BG00133.7± 10.70 BG00233.8± 10.56

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00035 BG00134 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0009 BG00110 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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)

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Units	Counts
Participants	OG000202 OG001204

Title

Denominators

Categories

Microbiological success

Title	Measurements
	OG000187 OG001186

Microbiological failure, BP

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Adjusted Difference in Percent	-0.1			2-Sided	95	-5.6	5.5					Non-Inferiority	The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Non-inferiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above -10.0%.

Secondary

Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC Visit

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.

Secondary

Number of Participants With Culture-Confirmed Bacterial Eradication of NG From the Pharyngeal Site at the TOC Visit

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.

Secondary

Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Any Serious Adverse Events (SAEs)

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.

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

Posted

Count of Participants

Participants

Up to 21 days

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes

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.

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

Posted

Mean

Standard Deviation

Giga cells per liter (10^9 cells/L)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb)

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.

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

Posted

Mean

Standard Deviation

Grams per liter (g/L)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Hematology Parameter: Hematocrit

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.

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

Posted

Mean

Standard Deviation

Percentage

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Hematology Parameter: Erythrocytes

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.

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

Posted

Mean

Standard Deviation

Trillion cells per liter (10^12 cells/L)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)

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.

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

Posted

Mean

Standard Deviation

Picograms (pg)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV)

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.

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

Posted

Mean

Standard Deviation

Femtoliters (fL)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium

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.

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

Posted

Mean

Standard Deviation

Millimoles per liter (mmol/L)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine

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.

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

Posted

Mean

Standard Deviation

Micromoles per liter (umol/L)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

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.

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

Posted

Mean

Standard Deviation

Grams per liter (g/L)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP)

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.

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

Posted

Mean

Standard Deviation

International units per Liter (IU/L)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Number of Participants With Urinalysis Dipstick Results

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Absolute Values in Specific Gravity of Urine

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.

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

Posted

Mean

Standard Deviation

Ratio

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Absolute Values in Potential of Hydrogen (pH) of Urine

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.

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

Posted

Mean

Standard Deviation

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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.

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

Posted

Mean

Standard Deviation

Millimeters of mercury (mmHg)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Vital Sign: Pulse Rate

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.

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

Posted

Mean

Standard Deviation

Beats per minute

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Secondary

Change From Baseline in Vital Sign: Temperature

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.

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

Posted

Mean

Standard Deviation

Celsius (C)

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

ID	Title	Description
OG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gepotidacin	Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.	0	309	1	309	230	309
EG001	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.	0	313	0	313	81	313

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v26.1	Systematic Assessment		EG0001 events1 affected309 at risk EG0010 events0 affected313 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG000167 events151 affected309 at risk EG00130 events30 affected313 at risk
Nausea	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG00080 events73 affected309 at risk EG0019 events9 affected313 at risk
Vomiting	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG00021 events20 affected309 at risk EG0012 events2 affected313 at risk
Flatulence	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG00020 events20 affected309 at risk EG0011 events1 affected313 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG00017 events16 affected309 at risk EG0014 events3 affected313 at risk
Faeces soft	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG00016 events16 affected309 at risk EG0011 events1 affected313 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0005 events5 affected309 at risk EG0012 events2 affected313 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0006 events6 affected309 at risk EG0011 events1 affected313 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v26.1	Systematic Assessment	EG0004 events4 affected309 at risk EG0012 events2 affected313 at risk
Chlamydial infection	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG00012 events12 affected309 at risk EG00110 events10 affected313 at risk
Urethritis chlamydial	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0006 events6 affected309 at risk EG0010 events0 affected313 at risk
Proctitis chlamydial	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0004 events4 affected309 at risk EG0011 events1 affected313 at risk
Nasopharyngitis	Infections and infestations	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected309 at risk EG0014 events4 affected313 at risk
Dizziness	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG00019 events16 affected309 at risk EG0012 events2 affected313 at risk
Headache	Nervous system disorders	MedDRA v26.1	Systematic Assessment	EG00010 events10 affected309 at risk EG0018 events8 affected313 at risk
Fatigue	General disorders	MedDRA v26.1	Systematic Assessment	EG0009 events8 affected309 at risk EG0010 events0 affected313 at risk
Injection site pain	General disorders	MedDRA v26.1	Systematic Assessment	EG0000 events0 affected309 at risk EG0015 events5 affected313 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v26.1	Systematic Assessment	EG0008 events7 affected309 at risk EG0010 events0 affected313 at risk
Vision blurred	Eye disorders	MedDRA v26.1	Systematic Assessment	EG0006 events6 affected309 at risk EG0010 events0 affected313 at risk

ID	Term
D006069	Gonorrhea

Ancestor Terms

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D015231	Sexually Transmitted Diseases, Bacterial
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
C000612856	gepotidacin
D002443	Ceftriaxone
D017963	Azithromycin

Ancestor Terms

ID	Term
D002439	Cefotaxime
D002505	Cephacetrile
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones

Units	Counts
Participants	OG000284 OG001293

Units	Counts
Participants	OG000284 OG001293

Units	Counts
Participants	OG000284 OG001293

Units	Counts
Participants	OG000284 OG001293

Units	Counts
Participants	OG000305 OG001306

Units	Counts
Participants	OG000307 OG001313