NCT04087759

A Study of Bedaquiline 100 Milligram (mg) Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001) in Healthy Adult Participants

Phase 1, Open-label, Randomized Crossover Study in Healthy Adult Subjects to Assess the Relative Oral Bioavailability and Food Effect of Bedaquiline 100-mg Tablets Administered as Different Test Formulations Compared to the Commercial Tablet Formulation (F001)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (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 rate and extent of absorption of bedaquiline following administration of a single oral dose of 100 milligram (mg) equivalent (1\*100 mg) given as different test tablet formulations compared to the administration of a single oral dose of 100 mg equivalent (1\*100 mg) formulated as SIRTURO commercial tablet (formulation F001), under fasted conditions in healthy adult participants. Also, to assess the effect of a standardized breakfast on the rate and extent of absorption of bedaquiline compared to fasted conditions following administration of a single oral dose of 100 mg equivalent (1\*100 mg) for each of the different test tablet formulations.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Bedaquiline (Test formulation)	Participants will receive bedaquiline orally.
DRUG	Bedaquiline (Reference formulation)	Participants will receive bedaquiline orally.

Timeline

• Start date: 2019-09-16
• Primary completion: 2020-01-07
• Completion: 2020-01-07
• First posted: 2019-09-12
• Last updated: 2025-02-03

Locations

1 site across 1 country: Belgium