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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01153542
Other study ID # VX10-770-011
Secondary ID
Status Completed
Phase Phase 1
First received June 28, 2010
Last updated December 8, 2010
Start date June 2010
Est. completion date August 2010

Study information

Verified date December 2010
Source Vertex Pharmaceuticals Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
VX-770
In period 1, subjects will receive a single oral dose of desipramine on Day 1.
VX-770
In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.

Locations

Country Name City State
United States Covance CRU, Inc. Daytona Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01208285 - Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects Phase 1