Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00836602
First received: January 30, 2009
Last updated: February 22, 2011
Last verified: August 2009
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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 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 June 18, 2013