In Development for Cystic Fibrosis Clinical Trial
Official title:
An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects
The objective of this study is to evaluate the effects of VX-770 on Desipramine
Status | Completed |
Enrollment | 24 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Covance CRU, Inc. | Daytona Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Vertex Pharmaceuticals Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VX-770 and Desipramine pharmacokinetic parameters | 3 weeks | No | |
Secondary | Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments | 3 weeks | Yes | |
Secondary | Metabolites pharmacokinetic parameters in plasma | 3 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01208285 -
Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects
|
Phase 1 |