TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Etravirine; Rilpivirine

Criteria

Inclusion Criteria:

• Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection

• A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2

• Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at Screening

• Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study, or have a vasectomized partner, or if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control.

Exclusion Criteria:

• History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures

• A positive urine drug test at Screening

• Use of disallowed therapies: concomitant medication, including over-the-counter products, herbal preparations and dietary supplements

• History of significant drug allergy

• Received an investigational drug or used an investigational medical device within 60 days preceding the first intake of study medication or having previously participated in a study with either ETR, TMC278, telaprevir.