Drug-drug Interaction Study of Gepotidacin
Drug-drug Interaction Study of Gepotidacin
NCT ID: NCT04493931 Phase: PHASE1 Status: COMPLETED Enrollment: 64 Completion: 2020-12-21
Conditions
Infections, Bacterial
Interventions
Gepotidacin, Cimetidine, Rifampicin, Midazolam, Digoxin, Placebo matching to gepotidacin
Summary
This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability study in adult healthy participants, including Japanese cohort. This study is designed to assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and establishing PK and safety in Japanese participants in cohort 4. Food effect will also be evaluated in cohort 4.
Primary Outcome
Cohort 1: Maximum Observed Concentration (Cmax) of Gepotidacin in Plasma