drugset / Trial / NCT01288755

TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir

NCT01288755

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to investigate the effect of steady-state concentrations of raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of TMC278 (25 mg, once daily), and vice versa. Steady state is a term that means that the drug has been given long enough so that the plasma levels will remain at about the same level with each subsequent dose. TMC278 is being investigated for the treatment of human immunodeficiency virus (HIV) infection. Raltegravir is a commercially available antiretroviral drug for treatment of HIV infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

Timeline

Start
2011-02
Primary completion
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Raltegravir Other / unclassified 400 mg
Subject Rilpivirine Small molecule 25 mg