NCT01018368

Study of VX-770 and Rifampin in Healthy Male Subjects

An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	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.
DRUG	Rifampin	In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-11-23
• Last updated: 2010-05-10

Locations

1 site across 1 country: United States