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TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435

2014-07-23 21:11:11 | BioPortfolio

Summary

The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. In addition, the short-term safety and tolerability of TMC435 in participants with hepatic impairment will be determined. The results of this study will guide dose recommendations for TMC435 in patients with impaired liver function.

Description

This is a Phase I, open-label trial to investigate the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of TMC435 in 8 participants with moderate hepatic impairment and 8 participants with severe hepatic impairment as compared to 8 participants with normal hepatic function, matched for age, gender, race, BMI (body mass index = weight in kilogram divided by square of height in meters) and smoking status. Open-label means that the study doctor and the participants know what treatment will be assigned to them. All participants will receive 150 mg of TMC435 by mouth for 7 days. Participants with severe hepatic impairment will be treated when the pharmacokinetic profiles of TMC435 in participants with moderate hepatic impairment have been evaluated. The dose of TMC435 may be changed for participants with severe hepatic impairment after evaluation of the blood levels TMC435 in participants with moderately impaired hepatic function. Tolerability and safety of TMC435 will be assessed throughout the trial period. Illnesses and side effects will be checked at every visit. Blood samples will be taken at screening, on the day before TMC435 intake, on days 2, 3, 5, 6, 7 (11 times), 8 and 9 and at 2 follow-up visits. Blood levels of TMC435 will be determined on days 2, 5, 6, 7, 8 and 9. Urine samples, ECG and vital signs will be taken at screening, twice on day 7 and at 2 follow-up visits. A physical examination will be done at screening, on the day before TMC435 intake, on day 9 and at both follow-up visits. All participants will receive a 150 mg dose of TMC435 for 7 days, given by mouth as 2 capsules of 75 mg. After evaluation of the pharmacokinetic profiles of TMC435 in participants with moderate hepatic impairment, the dose may be changed for participants with severe hepatic impairment.

Study Design

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

Conditions

Hepatitis C Virus

Intervention

TMC435

Location

Orlando
Florida
United States

Status

Recruiting

Source

Tibotec Pharmaceuticals, Ireland

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:11-0400

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Medical and Biotech [MESH] Definitions

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

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A strain of HEPATITIS A VIRUS which causes hepatitis in humans. The virus replicates in hepatocytes and is presumed to reach the intestine via the bile duct. Transmission occurs by the fecal-oral route.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

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