A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec BVBA
• Treatments: Bedaquiline; Diarylquinolines

Criteria

Inclusion Criteria:

• For healthy participant Panel A: Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at screening

• Should match to a patient with hepatic impairment with regards to sex, age (more or less to 5 years), and body mass index

• For patients in Panel B with moderate hepatic impairment: history of hepatic disease, documented liver cirrhosis and moderate liver function impairment defined by the Child-Pugh classification

Exclusion Criteria:

• A positive tuberculin skin test indicating latent tuberculosis

• A positive human immunodeficiency virus (HIV)-1 or HIV-2 test at screening

• Moderate hepatic impairment patients with acute hepatitis, Hepatic carcinoma, Grade 3 or 4 encephalopathy, or active candidate for liver transplantation

• Matched healthy participants with current active hepatic disease