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

NCT ID: NCT01597895

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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maraviroc boceprevir telaprevir drug interaction pharmacokinetics HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Maraviroc

Group Type ACTIVE_COMPARATOR

Maraviroc

Intervention Type DRUG

Maraviroc 150 mg BID x 5 days with food

Maraviroc + Boceprevir

Group Type EXPERIMENTAL

Maraviroc + Boceprevir

Intervention Type DRUG

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

Maraviroc + Telaprevir

Group Type EXPERIMENTAL

Maraviroc + Telaprevir

Intervention Type DRUG

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

Interventions

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Maraviroc + Boceprevir

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

Intervention Type DRUG

Maraviroc + Telaprevir

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

Intervention Type DRUG

Maraviroc

Maraviroc 150 mg BID x 5 days with food

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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A4001108

Identifier Type: -

Identifier Source: org_study_id