Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770
- Registration Number
- NCT01060566
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The objectives of this study are to evaluate the effects of VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Subjects must be male or female and between 18 and 55 years of age.
- Subjects must be judged to be in good health.
- Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.
Exclusion Criteria
- History of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject.
- Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.
- Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
- History of cardiovascular disease, hypoglycemia, or edema.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VX-770 VX-770 - Midazolam VX-770 - Rosiglitazone VX-770 - Fluconazole VX-770 -
- Primary Outcome Measures
Name Time Method Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter 11 days Fluconazole and VX 770 PK parameters 10 days
- Secondary Outcome Measures
Name Time Method 1´ hydroxy midazolam PK parameters in plasma 11 days Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments 21 days Metabolites PK parameters in plasma 21 days
Trial Locations
- Locations (1)
Covan CRU, Inc.
🇺🇸Daytona Beach, Florida, United States