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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836602
First Posted: February 4, 2009
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00836602     History of Changes
Other Study ID Numbers: CV197-002
First Submitted: January 30, 2009
First Posted: February 4, 2009
Last Update Posted: February 23, 2011
Last Verified: August 2009

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