TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects.

Summary

This is a Phase I, open-label, 3-period crossover trial to investigate the pharmacokinetic interaction (process by which a drug is absorbed, distributed, metabolised and eliminated by the body) between TMC125 and fluconazole, and between TMC125 and voriconazole.

Timeline

Start

2008-09

Primary completion

2009-01

Completion

2009-01

Publications

• Kakuda TN, Van Solingen-Ristea R, Aharchi F, Smedt GD, Witek J, Nijs S, Vyncke V, Hoetelmans RM. Pharmacokinetics and short-term safety of etravirine in combination with fluconazole or voriconazole in HIV-negative volunteers. J Clin Pharmacol. 2013 Jan;53(1):41-50. doi: 10.1177/0091270011433329. Epub 2013 Jan 24.

Drugs

Indications