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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VX-770

Group Type EXPERIMENTAL

VX-770

Intervention Type DRUG

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.

VX-770

Intervention Type DRUG

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.

Midazolam

Group Type EXPERIMENTAL

VX-770

Intervention Type DRUG

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.

Rosiglitazone

Group Type EXPERIMENTAL

VX-770

Intervention Type DRUG

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.

Fluconazole

Group Type EXPERIMENTAL

VX-770

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes