drugset / Trial / NCT00828789

VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer

NCT00828789

Phase 1 Completed 20 enrolled Tibotec BVBA
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to determine the effect of EFV (Efavirenz) and TDF (Tenofovir disoproxil fumarate) on the pharmacokinetics of TVR (Telaprevir) and to determine the effect of TVR on the pharmacokinetics of EFV and TDF. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. Furthermore, the short-term safety and tolerability of giving TVR, EFV and TDF together will be evaluated.

Timeline

Start
2009-02
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Efavirenz Other / unclassified
Subject Telaprevir Small molecule
Subject Tenofovir disoproxil fumarate Small molecule