Healthy
Conditions
Keywords
maraviroc, boceprevir, telaprevir, drug interaction, pharmacokinetics, HIV
Brief summary
The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.
Interventions
DRUGMaraviroc
Maraviroc 150 mg BID x 5 days with food
DRUGMaraviroc + Boceprevir
Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food
DRUGMaraviroc + Telaprevir
Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food
Sponsors
Pfizer
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maraviroc plasma pharmacokinetic parameters: AUC12, Cmax, and C12h on Period 1, Day 5 and Periods 2 and 3, Day 10 | 25 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed