Who is sponsoring NCT00933894?

NCT00933894 is sponsored by Tibotec BVBA.

What condition does NCT00933894 study?

NCT00933894 studies Hepatitis C.

What drugs are being tested in NCT00933894?

Interventions: Telaprevir; Escitalopram.

What is the status of NCT00933894?

NCT00933894 is currently COMPLETED.

Last reviewed 2010-12-16 · How we verify

A Phase I, Open-label, Randomized, Crossover Trial in 16 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Escitalopram at Steady-state

NCT00933894 Phase 1 COMPLETED

The purpose of this study is to investigate the effect of steady-state telaprevir (TVR) 750 mg q8h (3 times a day, every 8 hours) on the steady-state pharmacokinetics of escitalopram 10 mg q.d. (once a day), 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. TVR 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.

Details

Lead sponsor	Tibotec BVBA
Phase	Phase 1
Status	COMPLETED
Enrolment	16
Start date	2009-09
Completion	2009-11

Conditions

Hepatitis C

Interventions

Telaprevir; Escitalopram

Primary outcomes

To investigate the effect at steady-state of TVR 750 mg q8h on the steady-state pharmacokinetics of escitalopram 10 mg q.d. in healthy participants and vica versa. — pk profiles of TVR will be measured up to 8 hours after intake of the morning dose on Day 7 and 14 of Treatment B. Pharmacokinetic profiles of escitalopram will be measured up to 24 hours postdose on Day 7of Treatment A and Day 14 of Treatment B.