Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Phase 1
Completed
- Conditions
- Atherosclerosis
- Interventions
- Drug: BMS-779788Drug: Placebo
- Registration Number
- NCT00836602
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-779788 or Placebo (Arm 1) BMS-779788 - BMS-779788 or Placebo (Arm 1) Placebo - BMS-779788 or Placebo (Arm 2) BMS-779788 - BMS-779788 or Placebo (Arm 2) Placebo - BMS-779788 or Placebo (Arm 3) BMS-779788 - BMS-779788 or Placebo (Arm 3) Placebo -
- Primary Outcome Measures
Name Time Method Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests 8 times within 27 days of the first dose
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers) After each dose panel
Trial Locations
- Locations (1)
Local Institution
🇦🇺Heidelberg, Victoria, Australia