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Safety Study to Evaluate BMS-830216 in Healthy Subjects

NCT ID: NCT00878020

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

BMS-830216 (10 mg)

Group Type ACTIVE_COMPARATOR

BMS-830216

Intervention Type DRUG

Capsules, Oral, Single Dose, 1 day

Placebo

Intervention Type DRUG

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

Arm 2

BMS-830216 (30 mg)

Group Type ACTIVE_COMPARATOR

BMS-830216

Intervention Type DRUG

Capsules, Oral, Single Dose, 1 day

Placebo

Intervention Type DRUG

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

Arm 3

BMS-830216 (100 mg)

Group Type ACTIVE_COMPARATOR

BMS-830216

Intervention Type DRUG

Capsules, Oral, Single Dose, 1 day

Placebo

Intervention Type DRUG

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

Arm 4

BMS-830216 (300 mg)

Group Type ACTIVE_COMPARATOR

BMS-830216

Intervention Type DRUG

Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days

Placebo

Intervention Type DRUG

Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days

Arm 5

BMS-830216 (600 mg)

Group Type ACTIVE_COMPARATOR

BMS-830216

Intervention Type DRUG

Capsules, Oral, Single Dose, 1 day

Placebo

Intervention Type DRUG

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

Arm 6

BMS-830216 (1200 mg)

Group Type ACTIVE_COMPARATOR

BMS-830216

Intervention Type DRUG

Capsules, Oral, Single Dose, 1 day

Placebo

Intervention Type DRUG

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

Interventions

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BMS-830216

Capsules, Oral, Single Dose, 1 day

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

BMS-830216

Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days

Intervention Type DRUG

Placebo

Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45

Exclusion Criteria

* 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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Ppd Development, Lp

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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MB123-001

Identifier Type: -

Identifier Source: org_study_id

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