NCT03800550

A Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Participants

A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-Drug Interaction Between Bedaquiline and Clarithromycin in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the effect of steady-state clarithromycin once every 12 hour on the pharmacokinetic parameters of bedaquiline and its active metabolite M2 after a single dose of bedaquiline.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Bedaquiline	Bedaquiline tablet will be administered, orally.
DRUG	Clarithromycin	Clarithromycin tablet will be administered, orally.

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-06-04
• Completion: 2019-06-04
• First posted: 2019-01-11
• Last updated: 2025-02-03

Locations

1 site across 1 country: Belgium