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

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BMS-779788
BMS-779788
BMS-779788
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atherosclerosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

BMS-779788 or Placebo (Arm 1)

BMS-779788 or Placebo (Arm 2)

BMS-779788 or Placebo (Arm 3)

Arm Description

Outcomes

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

Secondary Outcome Measures

Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)

Full Information

First Posted
January 30, 2009
Last Updated
February 22, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00836602
Brief Title
Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Official Title
Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-779788 or Placebo (Arm 1)
Arm Type
Active Comparator
Arm Title
BMS-779788 or Placebo (Arm 2)
Arm Type
Active Comparator
Arm Title
BMS-779788 or Placebo (Arm 3)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-779788
Intervention Description
Oral Solution, Oral, 1 mg, Once daily, 7 days
Intervention Type
Drug
Intervention Name(s)
BMS-779788
Intervention Description
Oral Solution, Oral, 2 mg, Once daily, 7 days
Intervention Type
Drug
Intervention Name(s)
BMS-779788
Intervention Description
Oral Solution, Oral, <= 4 mg, Once daily, 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Solution, Oral, 0 mg, Once daily, 7 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)
Time Frame
After each dose panel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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