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

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 orwithout pharyngeal and/or rectal gonococcal infection and have one of the following:male participants with purulent yellow, green, or white urethral discharge or femaleparticipants with abnormal cervical or vaginal mucopurulent discharge upon physicalexamination; or a prior positive culture for N. gonorrhoeae from up to 5 days beforescreening (as long as the participant has not received any treatment for thisinfection); or a Gram or equivalent stain (urogenital specimens only) positive orpresumptive for Gram-negative intracellular diplococci from up to 5 days beforescreening (as long as the participant has not received any treatment for thisinfection); 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 notreceived any treatment for this infection).

• Participants who are willing to avoid anal, oral, and vaginal sexual intercourse oruse condoms for all forms of intercourse from the Baseline Visit through the TOCVisit.

• Male or female participants having his or her original urogenital anatomy at birth.

• Male participant must agree to use contraception (male condoms) during intercoursefrom the Baseline Visit through completion of the TOC Visit.

• Female participant is eligible to participate if she is not pregnant, notbreastfeeding, and at least 1 of the following conditions applies: Not a woman ofchildbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptiveguidance (male partners of WOCBP must use a male condom during intercourse) from theBaseline Visit through completion of the TOC Visit.

• Participants who are capable of giving signed informed consent or assent, whichincludes compliance with the requirements and restrictions listed in the informedconsent form (ICF) or assent form and in study protocol.

Exclusion Criteria:

• Male participants with a current diagnosis of epididymitis and/or orchitis at thetime of the Baseline Visit.

• Participant who is suspected or confirmed to have a Chlamydia trachomatis infectionand per the investigator's judgement standard-of-care treatment for this infectioncannot be safely postponed until the TOC Visit.

• Participant has a body mass index >=40 kilogram per square meter (kg/m^2) or has abody mass index >=35.0 kg/m^2 and is experiencing obesity-related health conditionssuch as high blood pressure or diabetes.

• Participant has a history of sensitivity to the study treatments, or componentsthereof, or a history of a drug (including erythromycin and any macrolide orketolide drug) or other allergy that, in the opinion of the investigator or medicalmonitor, contraindicates his or her participation.

• Participant is immunocompromised or has altered immune defenses that may predisposethe participant to a higher risk of treatment failure and/or complications.

• Participants with a known cluster of differentiation 4 (CD4) count of <200 cells percubic millimeter (cells/mm^3).

• Participant has any of the following: poorly controlled asthma or chronicobstructive pulmonary disease, acute severe pain, uncontrolled with conventionalmedical management, active peptic ulcer disease, Parkinson disease, Myastheniagravis, a history of seizure disorder requiring medications for control orparticipant has any surgical or medical condition that may interfere with drugabsorption, 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 significantelevated serum creatinine as determined by the investigator).

• Participant in the judgment of the investigator, would not be able or willing tocomply with the protocol or complete study follow-up.

• Participant has a serious underlying disease that could be imminently lifethreatening, or the participant is unlikely to survive for the duration of the studyperiod.

• Participant has congenital long QT syndrome or known prolongation of corrected QTinterval (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 symptomaticbradycardia or bradyarrhythmia within the last 12 months.

• The participant is taking QT-prolonging drugs or drugs known to increase the risk oftorsades de pointes (TdP) per the www.crediblemeds.org "Known Risk of TdP" categoryat the time of his or her Baseline Visit, which cannot be safely discontinued fromthe Baseline Visit to the TOC Visit; or the participant is taking a strongcytochrome P450 enzyme 3A4 (CYP3A4) inhibitor or a strong P-glycoprotein (P-gp)inhibitor.

• For any participant >=12 to <18 years, the participant has an abnormalelectrocardiogram (ECG) reading.

• The participant has a QTc >450 millisecond (msec) or a QTc >480 msec forparticipants with bundle-branch block.

• Participant has a documented or recent history of uncorrected hypokalemia within thepast 3 months.

• Participant has a known history of cholestatic jaundice or hepatic dysfunctionassociated with prior use of azithromycin.

• Participant has a known alanine aminotransferase (ALT) value >2 times upper limit ofnormal (ULN).

• Participant has a known bilirubin value >1.5 times ULN (isolated bilirubin >1.5times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

• Participant has a current or chronic history of liver disease, or known hepatic orbiliary abnormalities (with the exception of Gilbert's syndrome or asymptomaticgallstones), including symptomatic viral hepatitis or moderate-to-severe liverinsufficiency (Child Pugh class B or C).

• Participant has been previously randomized in this study or has previously beentreated with Gepotidacin.

• Participant has participated in a clinical trial and has received an investigationalproduct within 30 days or 5 half-lives, whichever is longer.

• Participant has any of the following gonococcal infections that require a differentdose or duration of treatment: suspected or confirmed pelvic inflammatory disease;or suspected or confirmed gonococcal arthritis; or suspected or confirmed gonococcalconjunctivitis; or suspected or confirmed gonococcal endocarditis; or other evidenceof disseminated gonococcal infection.

• Participant has received any antibacterial therapy for the treatment of a gonococcalinfection within 14 days before the Baseline Visit.

• Participant has received any systemic, topical, or intravaginal antibiotics or anysystemic antifungals within 7 days before the Baseline Visit.

• Participant must not use St John's wort or ergot derivatives from within 14 daysbefore the Baseline Visit through the TOC Visit.