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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01012284
Other study ID # CR007501
Secondary ID TMC207-TiDP13-C1
Status Completed
Phase Phase 1
First received November 12, 2009
Last updated December 19, 2012
Start date January 2010
Est. completion date January 2011

Study information

Verified date December 2012
Source Tibotec BVBA
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tibotec BVBA

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Number of patients with adverse events as a measure of safety and tolerability up to Day 29 Yes
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