NCT04493931

Drug-drug Interaction Study of Gepotidacin

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	Gepotidacin	Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
DRUG	Cimetidine	Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.
DRUG	Rifampicin	Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.
DRUG	Midazolam	Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.
DRUG	Digoxin	Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.
OTHER	Placebo matching to gepotidacin	Placebo matching to gepotidacin tablets will be administered orally.

Timeline

• Start date: 2020-08-14
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2020-07-30
• Last updated: 2022-03-04
• Results posted: 2022-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study