A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

Tibotec Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Moderate Hepatic Impairment

Treatments: Drug: TMC207

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012284

CR007501

TMC207-TiDP13-C112 (Other Identifier)

2009-016437-99 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This is a Phase I, open label (all people know the identity of the intervention) study of TMC207. The study consists of a screening period and a 4-weeks treatment period. Sixteen participants will be enrolled in two panels. Panel A will include 8 patients of moderate hepatic impairment and Panel B will include 8 healthy participants. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The entire study duration for each participant will be approximately 7 weeks.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Panel A

Experimental group

Description:

8 patients with moderate hepatic impairment classified as moderate as per the Child Pugh Classification.

Treatment:

Drug: TMC207

Panel B

Experimental group

Description:

8 healthy participants who will match to patients with hepatic impairment in Panel A with regards to sex, age (more or less to 5 years), and body mass index.

Treatment:

Drug: TMC207