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

NCT ID: NCT00836602

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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BMS-779788 or Placebo (Arm 1)

Group Type ACTIVE_COMPARATOR

BMS-779788

Intervention Type DRUG

Oral Solution, Oral, 1 mg, Once daily, 7 days

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, 7 days

BMS-779788 or Placebo (Arm 2)

Group Type ACTIVE_COMPARATOR

BMS-779788

Intervention Type DRUG

Oral Solution, Oral, 2 mg, Once daily, 7 days

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, 7 days

BMS-779788 or Placebo (Arm 3)

Group Type ACTIVE_COMPARATOR

BMS-779788

Intervention Type DRUG

Oral Solution, Oral, \<= 4 mg, Once daily, 7 days

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, 7 days

Interventions

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BMS-779788

Oral Solution, Oral, 1 mg, Once daily, 7 days

Intervention Type DRUG

BMS-779788

Oral Solution, Oral, 2 mg, Once daily, 7 days

Intervention Type DRUG

BMS-779788

Oral Solution, Oral, \<= 4 mg, Once daily, 7 days

Intervention Type DRUG

Placebo

Oral Solution, Oral, 0 mg, Once daily, 7 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Heidelberg, Victoria, Australia

Site Status

Countries

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Australia

Related Links

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Other Identifiers

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CV197-002

Identifier Type: -

Identifier Source: org_study_id

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