Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770

Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770

Sponsor:
Vertex Pharmaceuticals Incorporated

Information provided by:
Vertex Pharmaceuticals Incorporated

Purpose
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.

Drug: VX-770

Phase I

Study Design:
Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study

Official Title:
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

Primary Outcome Measures:
Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Fluconazole and VX 770 PK parameters [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
1´ hydroxy midazolam PK parameters in plasma [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Metabolites PK parameters in plasma [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment:
24

Study Start Date:
February 2010

Estimated Study Completion Date:
March 2010

Estimated Primary Completion Date:
March 2010 (Final data collection date for primary outcome measure)

VX-770: Experimental
Drug: VX-770

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. Drug: VX-770

In period 2, subjects will receive 150 mg VX-770 q12h orally from Day 1 through the morning of Day 8. On the morning of Period 2 Day 1, subjects will receive a 400 mg loading dose of fluconazole. Thereafter, subjects will receive 200 mg fluconazole qd orally from Day 2 through Day 9.

Ages Eligible for Study:
18 Years to 55 Years

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.

Contacts
Contact: Medical Monitor
617.444.6777
medicalinfo@vrtx.com

Locations
United States, Florida
Covan CRU, Inc.
Daytona Beach, Florida, United States, 32117

Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Principal Investigator:
H. Frank Farmer, MD
Covance CRU, Inc.