Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00836602
First received: January 30, 2009
Last updated: February 22, 2011
Last verified: August 2009

January 30, 2009
February 22, 2011
February 2009
July 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00836602 on ClinicalTrials.gov Archive Site
Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers) [ Time Frame: After each dose panel ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Atherosclerosis
  • Drug: BMS-779788
    Oral Solution, Oral, 1 mg, Once daily, 7 days
  • Drug: BMS-779788
    Oral Solution, Oral, 2 mg, Once daily, 7 days
  • Drug: BMS-779788
    Oral Solution, Oral, <= 4 mg, Once daily, 7 days
  • Drug: Placebo
    Oral Solution, Oral, 0 mg, Once daily, 7 days
  • Active Comparator: BMS-779788 or Placebo (Arm 1)
    Interventions:
    • Drug: BMS-779788
    • Drug: Placebo
  • Active Comparator: BMS-779788 or Placebo (Arm 2)
    Interventions:
    • Drug: BMS-779788
    • Drug: Placebo
  • Active Comparator: BMS-779788 or Placebo (Arm 3)
    Interventions:
    • Drug: BMS-779788
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00836602
CV197-002
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
August 2009

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