A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

Moderate Hepatic Impairment Clinical Trial

Official title:

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

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

• Liver Diseases
• Moderate Hepatic Impairment

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

External Links

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