drugset / Trial / NCT01205139

TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir

NCT01205139

Phase 1 Completed 48 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , 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. TMC278 and Tenofovir 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.

Timeline

Start
2010-11
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilpivirine Small molecule 25 mg
Subject Simeprevir Small molecule 150 mg Oral
Subject Simeprevir Small molecule 150 mg
Subject Tenofovir disoproxil fumarate Small molecule 300 mg Oral