Pharmacokinetics of Gepotidacin in Renal Impairment.

ABSTRACT: Gepotidacin is a novel triazaacenaphthylene bacterial topoisomerase inhibitor. In this phase 1, nonrandomized, open-label, parallel-group, multicenter, multipart study, the pharmacokinetics, safety, and tolerability of a single intravenous (IV) dose of gepotidacin 750 mg over 2 hours were evaluated in subjects with normal renal function, in those with moderate and severe renal impairment, and in end-stage renal disease (ESRD) on and not on dialysis. Administration of IV gepotidacin 750 mg was safe and generally tolerated in the study subjects. Dosing in severe renal impairment with and without hemodialysis resulted in significant increases in plasma drug levels and decreases in clearance. The geometric mean elimination half-life (t_½ ) was minimally impacted (range 9.45 to 11.5 h

SUBMITTER: Hossain M 

PROVIDER: S-EPMC7384084 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature