In Development for Cystic Fibrosis
Conditions
Brief summary
The objective of this study is to evaluate the effects of VX-770 on Desipramine
Interventions
DRUGVX-770
In period 1, subjects will receive a single oral dose of desipramine on Day 1.
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 * Subject must have a body mass index (BMI) from 18 to 30 kg/m2 * Subject must be judged to be in good health
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, hepatitis C, or active hepatitis B * Female subjects and male subjects with female partner(s) who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VX-770 and Desipramine pharmacokinetic parameters | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments | 3 weeks |
| Metabolites pharmacokinetic parameters in plasma | 3 weeks |
Countries
United States
Outcome results
None listed