At a glance
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A Pharmacokinetic, Multi-cohort Study in Healthy Adult Subjects to Assess Gepotidacin as Victim and as Perpetrator of Drug-Drug Interactions Via CYP450, Renal and Intestinal Transporters, and to Assess Gepotidacin Pharmacokinetics in Japanese Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Gepotidacin, Cimetidine, and 4 other interventions for Infections, Bacterial. Completed, enrolled 64 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.
Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.
Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.
Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.
Placebo matching to gepotidacin tablets will be administered orally.