Study of VX-770 and Rifampin in Healthy Male Subjects
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|ClinicalTrials.gov Identifier: NCT01018368|
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : May 10, 2010
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: VX-770 Drug: Rifampin||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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
- VX 770 pharmacokinetic (PK) parameters [ Time Frame: 17 days ]
- VX 770 metabolite PK parameters in plasma [ Time Frame: 17 days ]
- Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin [ Time Frame: 17 days ]
- Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments [ Time Frame: 17 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018368
|United States, Florida|
|Daytona Beach, Florida, United States|
|Principal Investigator:||H. Frank Farmer, MD||Covance CRU, Inc.|