Efficacy and Safety Study of Gepotidacin in the Treatment of Uncomplicated Urogenital Gonorrhea

Phase 1

• Conditions: ncomplicated Urogenital Gonorrhea; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-001780-23-GB
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-13
• Study Completion: 2023-10-10
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 628

Inclusion Criteria

1. The participant is =12 years at the time of signing the informed consent/assent and has a body weight >45 kg
2. The participant has clinical suspicion of a urogenital gonococcal infection with or without pharyngeal and/or rectal gonococcal infection and has 1 of the following:
- a prior positive culture for NG from up to 5 days before Screening (as long as the participant has not received any treatment for this infection)
- a Gram 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 NAAT assay for NG from up to 7 days before Screening (as long as the participant has not received any treatment for this infection).
3. The participant must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all forms of intercourse from the Baseline Visit through the TOC Visit.
4. Male or female and must have his or her original urogenital anatomy at birth
a. Male participants: A male participant must agree to use contraception as detailed in Appendix 6 of the protocol from the Baseline Visit through completion of the TOC Visit.
b. Female participants:
A female participant is eligible to participate if she is not pregnant(see Appendix 6), not breastfeeding, and at least 1 of the following conditions applies:
(i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 6 OR
(ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 6 from the Baseline Visit through completion of the TOC Visit.
5. The participant is capable of giving signed informed consent/assent as described in Appendix 3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)/assent form and in the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. The participant is a male with a current diagnosis of epididymitis and/or orchitis at the time of the Baseline Visit.
2. The participant is suspected or confirmed to have a CT infection and per the investigator’s judgement standard-of-care treatment for this infection cannot be safely postponed until the TOC Visit.
3. The participant has a body mass index =40 kg/m2 or has a body mass index =35.0 kg/m2 and is experiencing obesity-related health conditions such as high blood pressure or diabetes.
4. The participant has a history of sensitivity to the study treatments, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation.
5. The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications
6. The participant has any of the following:
-Medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase
OR
-Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study treatment (e.g., ileostomy or malabsorption syndrome).
7. The participant has known anuria, oliguria, or severe impairment of renal function (creatinine clearance <30 mL/min or clinically significant elevated serum creatinine as determined by the investigator).
8. The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
9. The 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.
10. The participant has congenital long QT syndrome or known prolongation of QTc.
11. The participant has uncompensated heart failure.
12. The participant has severe left ventricular hypertrophy.
13. The participant has a family history of QT prolongation or sudden death.
14. The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or bradyarrhythmia within the last 12 months.
15. With the exception of azithromycin study treatment, 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 CYP3A4 inhibitor or a strong P-glycoprotein (P-gp) inhibitor.
16. For any participant =12 to <18 years, the participant has an abnormal ECG reading.
17. The participant has a QTc >450 msec or a QTc >480 msec for participants with bundle-branch block.
18. The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
19. The participant has a known history of cholestatic jaundice or hepatic dysfunction associated with prior use of azithromycin.
20. The participant has a known alanine aminotransferase (ALT) value >2 × upper limit of normal (ULN).
21. The participant has a known bilirubin value >1.5 × ULN (isolated bilirubin >1.5 ×ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
22. The participant has a current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified