Moderate Hepatic Impairment Clinical Trial
Official title:
Pharmacokinetics, Safety, and Tolerability of TMC207 in Subjects With Moderately Impaired Hepatic Function
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 |
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.
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tibotec BVBA |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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