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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00836602 |
Date of registration:
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30/01/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
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Scientific title:
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Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects |
Date of first enrolment:
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February 2009 |
Target sample size:
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25 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00836602 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Contacts
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Name:
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Bristol-Myers Squibb |
Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women (not of child bearing potential) ages 18 to 45
- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
- Women of child bearing potential
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG or clinical laboratory determinations
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atherosclerosis
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Intervention(s)
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Drug: Placebo
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Drug: BMS-779788
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Primary Outcome(s)
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Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
[Time Frame: 8 times within 27 days of the first dose]
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Secondary Outcome(s)
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Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)
[Time Frame: After each dose panel]
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Secondary ID(s)
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CV197-002
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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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