NCT01012284

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

November 12, 2009

Last Update Submit

December 19, 2012

Conditions

Moderate Hepatic Impairment

Keywords

Moderate Hepatic ImpairmentTuberculosisTMC207Mycobacterial adenosine triphosphate (ATP)-synthase

Outcome Measures

Primary Outcomes (10)

  • Maximum plasma concentration of TMC207

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

  • Time to reach the maximum plasma concentration of TMC207

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

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

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

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

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

  • Area under curve extrapolated to infinity of TMC207

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

  • Maximum plasma concentration of N-monodesmethyl metabolite

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

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

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

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

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

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

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

  • Area under curve extrapolated to infinity of N-monodesmethyl metabolite

    0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 120, 168, 216, 264, 336, 504, 672 hours

Secondary Outcomes (1)

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

    up to Day 29

Study Arms (2)

Panel A

EXPERIMENTAL

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

Drug: TMC207

Panel B

EXPERIMENTAL

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.

Drug: TMC207

Interventions

TMC207DRUG

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)

Also known as: R207910
Panel APanel B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Tuberculosis

Interventions

bedaquiline

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Tibotec-Virco Virology BVBA Clinical Trial

    Tibotec BVBA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 13, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 20, 2012

Record last verified: 2012-12