drugset / Trial / NCT01012284

A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

NCT01012284

Phase 1 Completed 16 enrolled Tibotec BVBA
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the pharmacokinetics (what the body does to the medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in healthy participants and in patients with moderate hepatic impairment after administration of a single 400 mg dose of TMC207.

Timeline

Start
2010-01
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bedaquiline Small molecule 400 mg

Indications

No indication recorded.