Study of VX-770 on Desipramine

Phase 1

Completed

• Conditions: In Development for Cystic Fibrosis
• Interventions: Drug: VX-770

• Registration Number: NCT01153542
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The objective of this study is to evaluate the effects of VX-770 on Desipramine

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-30
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VX-770	VX-770	-
desipramine	VX-770	-

Primary Outcome Measures

Name	Time	Method
VX-770 and Desipramine pharmacokinetic parameters	3 weeks

Secondary Outcome Measures

Name	Time	Method
Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments	3 weeks
Metabolites pharmacokinetic parameters in plasma	3 weeks

Trial Locations

Locations (1)

Covance CRU, Inc.; 🇺🇸 Daytona Beach, Florida, United States