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Study of VX-770 and Rifampin in Healthy Male Subjects

2014-08-27 03:17:49 | BioPortfolio

Summary

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

Description

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

VX-770, Rifampin

Location

Daytona Beach
Florida
United States

Status

Completed

Source

Vertex Pharmaceuticals Incorporated

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:49-0400

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