Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects.

ABSTRACT: Gepotidacin, a novel, first-in-class triazaacenaphthylene antibiotic, inhibits bacterial DNA replication by a distinct mechanism of action. We report the pharmacokinetics (PKs), safety, and tolerability of gepotidacin following single or multiple ascending doses. Studies 1 and 2 were randomized, single-blind, placebo-controlled trials in healthy adults aged 18-60 years, who received single (study 1 [NCT02202187]; 100-3000 mg) or repeat (study 2 [NCT01706315]; 400 mg twice daily to 2000 mg thrice daily) ascending doses of gepotidacin. Study 3 (NCT02045849) was an open-label, three-part, study in healthy adults; here, we report on part 3, a two-period, repeat-dose, crossover study. Healthy elderly participants received repeat 1500 mg gepotidacin twice daily with or without a moderate-fat mea

SUBMITTER: Tiffany C 

PROVIDER: S-EPMC9468557 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature