Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis)
J. Scott Overcash, Courtney Tiffany, Nicole E. Scangarella-Oman, Caroline Perry, Tao Yu, Mohammad Hossain, Aline Barth, Étienne Dumont
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.
Topics & Concepts
MedicinePharmacokineticsUrinary systemAcute CystitisInternal medicineUrinary Tract Infections ManagementAntibiotics Pharmacokinetics and EfficacyAntibiotic Resistance in Bacteria