Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedApril 16, 2010
April 1, 2010
28 days
January 29, 2010
April 15, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
11 days
Fluconazole and VX 770 PK parameters
10 days
Secondary Outcomes (3)
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
Study Arms (4)
VX-770
EXPERIMENTALMidazolam
EXPERIMENTALRosiglitazone
EXPERIMENTALFluconazole
EXPERIMENTALInterventions
In period 1, subjects will receive a single oral dose of midazolam (2 mg) and on Day 1 and Day 8. Subjects will receive single oral dose of rosiglitazone 4 mg and on Day2 and Day 9. Subjects will receive multiple doses of VX-770 150 mg q12h Day 3-10.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covan CRU, Inc.
Daytona Beach, Florida, 32117, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H. Frank Farmer, MD
Covance CRU, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2010
First Posted
February 2, 2010
Study Start
February 1, 2010
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
April 16, 2010
Record last verified: 2010-04