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Study of VX-770 on Desipramine

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01153542
First received: June 28, 2010
Last updated: December 8, 2010
Last verified: December 2010
History of Changes

June 28, 2010
December 8, 2010
June 2010
August 2010   (final data collection date for primary outcome measure)
VX-770 and Desipramine pharmacokinetic parameters [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01153542 on ClinicalTrials.gov Archive Site
  • Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • Metabolites pharmacokinetic parameters in plasma [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of VX-770 on Desipramine
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
In Development for Cystic Fibrosis
  • Drug: VX-770
    In period 1, subjects will receive a single oral dose of desipramine on Day 1.
  • Drug: 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.
  • Experimental: VX-770
    Intervention: Drug: VX-770
  • Experimental: desipramine
    Interventions:
    • Drug: VX-770
    • Drug: VX-770
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01153542
VX10-770-011
No
Claudia Ordonez, MD, Vertex Pharmaceuticals, Inc.
Vertex Pharmaceuticals Incorporated
Not Provided
Principal Investigator: H. Frank Farmer, MD Covance CRU, Inc.
Vertex Pharmaceuticals Incorporated
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP