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A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

Primary Purpose

Moderate Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

TMC207

About this trial

This is an interventional treatment trial for Moderate Hepatic Impairment focused on measuring Moderate Hepatic Impairment, Tuberculosis, TMC207, Mycobacterial adenosine triphosphate (ATP)-synthase

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Panel A

Panel B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Maximum plasma concentration of TMC207

Time to reach the maximum plasma concentration of TMC207

Area under curve from time of administration up to 72 hours post dosing of TMC207

Area under curve from time of administration up to the last time point with a measurable concentration post dosing of TMC207

Area under curve extrapolated to infinity of TMC207

Maximum plasma concentration of N-monodesmethyl metabolite

Time to reach the maximum plasma concentration of N-monodesmethyl metabolite

Area under curve from time of administration up to 72 hours post dosing of N-monodesmethyl metabolite

Area under curve from time of administration up to the last time point with a measurable concentration post dosing of N-monodesmethyl metabolite

Area under curve extrapolated to infinity of N-monodesmethyl metabolite

Secondary Outcome Measures

Number of patients with adverse events as a measure of safety and tolerability

Full Information

NCT ID

NCT01012284

First Posted

November 12, 2009

Last Updated

December 19, 2012

Sponsor

Tibotec BVBA

1. Study Identification

Unique Protocol Identification Number

NCT01012284

Brief Title

A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

Official Title

Pharmacokinetics, Safety, and Tolerability of TMC207 in Subjects With Moderately Impaired Hepatic Function

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tibotec BVBA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate Hepatic Impairment

Keywords

Moderate Hepatic Impairment, Tuberculosis, TMC207, Mycobacterial adenosine triphosphate (ATP)-synthase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Panel A

Arm Type

Experimental

Arm Description

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

Arm Title

Panel B

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

TMC207

Other Intervention Name(s)

R207910

Intervention Description

400 mg (4 tablets of 100 mg) of TMC207 will be administered as a single dose on Day 1 of the treatment period to participants of both the Panels (Panel A and Panel B)

Primary Outcome Measure Information:

Title

Maximum plasma concentration of TMC207

Time Frame