Cystic Fibrosis
Conditions
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.
Interventions
DRUGVX-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.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter | 11 days |
| Fluconazole and VX 770 PK parameters | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed