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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: VX-770

Study type: Interventional

Funder types: Industry

Identifiers

NCT01060566

VX09-770-010

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

VX-770

Experimental group

Treatment:

Drug: VX-770

Drug: VX-770

Midazolam

Experimental group

Treatment:

Drug: VX-770

Drug: VX-770

Rosiglitazone

Experimental group

Treatment:

Drug: VX-770

Drug: VX-770

Fluconazole

Experimental group

Treatment:

Drug: VX-770

Drug: VX-770