Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis)

Author:

Overcash J. Scott1,Tiffany Courtney A.2,Scangarella-Oman Nicole E.2,Perry Caroline R.2,Tao Yu2,Hossain Mohammad2,Barth Aline2,Dumont Etienne F.2

Affiliation:

1. eStudySite, La Mesa, California, USA

2. GlaxoSmithKline, Collegeville, Pennsylvania, USA

Abstract

Gepotidacin, a triazaacenaphthylene bacterial type II topoisomerase inhibitor, is in development for treatment of uncomplicated urinary tract infection (uUTI). This phase 2a study in female participants with uUTI evaluated the pharmacokinetics (primary objective), safety, and exploratory efficacy of gepotidacin. Eligible participants ( n  = 22) were confined to the clinic at baseline, received oral gepotidacin at 1,500 mg twice daily for 5 days (on-therapy period; days 1 to 5), and returned to the clinic for test-of-cure (days 10 to 13) and follow-up (day 28 ± 3) visits.

Funder

GlaxoSmithKline

HHS | Biomedical Advanced Research and Development Authority

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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