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A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

NCT ID: NCT01012284

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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.

Conditions

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Moderate Hepatic Impairment

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel A

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

Group Type EXPERIMENTAL

TMC207

Intervention Type DRUG

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)

Panel B

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.

Group Type EXPERIMENTAL

TMC207

Intervention Type DRUG

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)

Interventions

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TMC207

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)

Intervention Type DRUG

Other Intervention Names

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R207910

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tibotec BVBA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tibotec-Virco Virology BVBA Clinical Trial

Role: STUDY_DIRECTOR

Tibotec BVBA

Countries

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Germany

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1632&filename=CR007501_CSR.pdf.pdf

An Open-Label, Prospective, Non-Comparative Study to Evaluate the Efficacy and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia.

Other Identifiers

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TMC207-TiDP13-C112

Identifier Type: OTHER

Identifier Source: secondary_id

2009-016437-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR007501

Identifier Type: -

Identifier Source: org_study_id