TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)

• Status: Completed
• Trial end date: 2011-08-01

Summary

The purpose of this study is to investigate the effect of steady-state concentrations of erythromycin or DRV/r on the steady-state pharmacokinetics of TMC435, the effect of a steady-state concentration of TMC435 (150 mg) on the steady-state pharmacokinetics of erythromycin and the effect of a steady-state concentration of TMC435 (50 mg) on the steady-state pharmacokinetics of DRV/r. We will also study the short-term safety and tolerability of TMC435 given alone and given togehter with erythromycin (Panel 1) or DRV/r (Panel 2). Steady state is a term that 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. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

• Phase: Phase 1

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Darunavir; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Ritonavir; Simeprevir