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
  Purpose

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


Condition Intervention Phase
Atherosclerosis
Drug: BMS-779788
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BMS-779788 or Placebo (Arm 1) Drug: BMS-779788
Oral Solution, Oral, 1 mg, Once daily, 7 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 7 days
Active Comparator: BMS-779788 or Placebo (Arm 2) Drug: BMS-779788
Oral Solution, Oral, 2 mg, Once daily, 7 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 7 days
Active Comparator: BMS-779788 or Placebo (Arm 3) Drug: BMS-779788
Oral Solution, Oral, <= 4 mg, Once daily, 7 days
Drug: Placebo
Oral Solution, Oral, 0 mg, Once daily, 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836602

Locations
Australia, Victoria
Local Institution
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00836602     History of Changes
Other Study ID Numbers: CV197-002
Study First Received: January 30, 2009
Last Updated: February 22, 2011
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014