Study of VX-770 and Rifampin in Healthy Male Subjects
The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- VX 770 pharmacokinetic (PK) parameters [ Time Frame: 17 days ] [ Designated as safety issue: No ]
- VX 770 metabolite PK parameters in plasma [ Time Frame: 17 days ] [ Designated as safety issue: No ]
- Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin [ Time Frame: 17 days ] [ Designated as safety issue: No ]
- Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments [ Time Frame: 17 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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.
In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018368
|United States, Florida|
|Daytona Beach, Florida, United States|
|Principal Investigator:||H. Frank Farmer, MD||Covance CRU, Inc.|