TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of efavirenz or raltegravir , and vice versa. Steady state is a term which means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Efavirenz and raltegravir are two antiretroviral drugs for treatment of human deficiency virus (HIV) infection. Pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Anti-Retroviral Agents; Efavirenz; Raltegravir Potassium; Simeprevir

Criteria

Inclusion Criteria:

• No-smoker for at least 3 months

• Body Mass Index of 18.0 to 30.0 kg/m2

• Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram

Exclusion Criteria:

• Infection with Hepatitis A, B or C Virus

• Infection with the Human Immunodeficiency Virus (HIV)

• History of, or any current medical condition which could impact the safety of the participant in the study

• Having previously participated in a multiple-dose trial with TMC435

• Having previously participated in more than 3 single-dose trials with TMC435.