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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836602
• Other study ID #: CV197-002
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2009
• Last updated: February 22, 2011
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• BMS-779788
Oral Solution, Oral, 1 mg, Once daily, 7 days
• BMS-779788
Oral Solution, Oral, 2 mg, Once daily, 7 days
• BMS-779788
Oral Solution, Oral, <= 4 mg, Once daily, 7 days
• Placebo
Oral Solution, Oral, 0 mg, Once daily, 7 days

Locations

Country	Name	City	State
Australia	Local Institution	Heidelberg	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)		After each dose panel	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form