Study of VX-770 and Rifampin in Healthy Male Subjects
- Registration Number
- NCT01018368
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VX-770 VX-770 - Rifampin Rifampin -
- Primary Outcome Measures
Name Time Method VX 770 pharmacokinetic (PK) parameters 17 days
- Secondary Outcome Measures
Name Time Method VX 770 metabolite PK parameters in plasma 17 days Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin 17 days Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments 17 days