Single Ascending Dose (BMS-813160) Study

NCT ID: NCT01049165

Last Updated: 2011-02-11

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-11-30

Brief Summary

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The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects

Detailed Description

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Conditions

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Accelerated Intimal Hyperplasia

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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Arm 1 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 5 mg, Single dose, 1 day

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Arm 2 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 20 mg, Single dose, 1 day

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Arm 3 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 60 mg, Single dose, 1 day

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Arm 4 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 150 mg, Single dose, 1 day

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Arm 5 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 300 mg, Single dose, 1 day

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Arm 6 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 600 mg, Single Dose, 1 day

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Arm 7 [14C] BMS-813160

Group Type ACTIVE_COMPARATOR

[14C] BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 150 mg, Single Dose, 1 day

Arm 8 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Single Dose, 1 day

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 1200 mg, Single dose, 1 day

Arm 9 (BMS-813160 or placebo)

Group Type ACTIVE_COMPARATOR

BMS-813160

Intervention Type DRUG

Oral Solution, Oral, 2000 mg, Single Dose, 1 day

Interventions

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BMS-813160

Oral Solution, Oral, 5 mg, Single dose, 1 day

Intervention Type DRUG

BMS-813160

Oral Solution, Oral, 20 mg, Single dose, 1 day

Intervention Type DRUG

BMS-813160

Oral Solution, Oral, 60 mg, Single dose, 1 day

Intervention Type DRUG

BMS-813160

Oral Solution, Oral, 150 mg, Single dose, 1 day

Intervention Type DRUG

BMS-813160

Oral Solution, Oral, 300 mg, Single dose, 1 day

Intervention Type DRUG

BMS-813160

Oral Solution, Oral, 600 mg, Single Dose, 1 day

Intervention Type DRUG

[14C] BMS-813160

Oral Solution, Oral, 150 mg, Single Dose, 1 day

Intervention Type DRUG

Placebo

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Intervention Type DRUG

BMS-813160

Oral Solution, Oral, 1200 mg, Single dose, 1 day

Intervention Type DRUG

BMS-813160

Oral Solution, Oral, 2000 mg, Single Dose, 1 day

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
* Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and 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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Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV202-001

Identifier Type: -

Identifier Source: org_study_id

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