Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

Sponsor

ViiV Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT01597895

Collaborator

Pfizer (Industry)

Enrollment

Location

Arms

Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Maraviroc Drug: Maraviroc + Boceprevir Drug: Maraviroc + Telaprevir	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Open-Label, Randomized, Fixed-Sequence, Crossover Study to Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Maraviroc	Drug: Maraviroc Maraviroc 150 mg BID x 5 days with food
Experimental: Maraviroc + Boceprevir	Drug: Maraviroc + Boceprevir Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food
Experimental: Maraviroc + Telaprevir	Drug: Maraviroc + Telaprevir Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food

Arm

Intervention/Treatment

Active Comparator: Maraviroc

Drug: Maraviroc

Maraviroc 150 mg BID x 5 days with food

Experimental: Maraviroc + Boceprevir

Drug: Maraviroc + Boceprevir

Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food

Experimental: Maraviroc + Telaprevir

Drug: Maraviroc + Telaprevir

Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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).