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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01153542 |
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Date of registration:
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28/06/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of VX-770 on Desipramine
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Scientific title:
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An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01153542 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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H. Frank Farmer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Covance CRU, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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In Development for Cystic Fibrosis
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Intervention(s)
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Drug: VX-770
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Primary Outcome(s)
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VX-770 and Desipramine pharmacokinetic parameters
[Time Frame: 3 weeks]
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Secondary Outcome(s)
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Safety as measured by adverse events, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments
[Time Frame: 3 weeks]
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Metabolites pharmacokinetic parameters in plasma
[Time Frame: 3 weeks]
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Secondary ID(s)
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VX10-770-011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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