NCT01060566CompletedPhase 1
An Open-Label Phase 1 Study to Examine the Effect of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 in Healthy Subjects
Vertex Pharmaceuticals Incorporated1 site in 1 country24 target enrollmentStarted: February 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Fluconazole
Experimental
Intervention: VX-770 (Drug)
Rosiglitazone
Experimental
Intervention: VX-770 (Drug)
Midazolam
Experimental
Intervention: VX-770 (Drug)
VX-770
Experimental
Intervention: VX-770 (Drug)
Outcomes
Primary Outcomes
Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
Time Frame: 11 days
Fluconazole and VX 770 PK parameters
Time Frame: 10 days
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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