Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT01597895
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male and/or female subjects.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >50 kg (110 lbs).
Exclusion Criteria
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Maraviroc Maraviroc - Maraviroc + Boceprevir Maraviroc + Boceprevir - Maraviroc + Telaprevir Maraviroc + Telaprevir -
- Primary Outcome Measures
Name Time Method Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10 25 days
- Secondary Outcome Measures
Name Time Method Maraviroc plasma pharmacokinetic parameters: Tmax on Period 1, Day 5 and Periods 2 and 3, Day 10 25 days Boceprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 2, Day 10 10 days Telaprevir plasma pharmacokinetic parameters: AUC8, Cmax, C8h, and Tmax on Period 3, Day 10 10 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium