Study of VX-770 and Rifampin in Healthy Male Subjects

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

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The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.

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Detailed Description

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This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.

All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VX-770

Group Type EXPERIMENTAL

VX-770

Intervention Type DRUG

In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.

Rifampin

Group Type EXPERIMENTAL

Rifampin

Intervention Type DRUG

In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

Interventions

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VX-770

In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.

Intervention Type DRUG

Rifampin

In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must be male and between 18 and 55 years of age
* Subject must have a body mass index (BMI) from 18 to 30 kg/m2

Exclusion Criteria

* History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
* Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes