Study With Healthy Japanese and Non-Asian Participants With BMS-986231

NCT ID: NCT02932969

Last Updated: 2017-05-31

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-04

Study Completion Date

2017-05-26

Brief Summary

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The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.

Detailed Description

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Conditions

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Heart Decompensation, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel 1 Arm

BMS-986231 and BMS-986231 Placebo intravenously

Group Type EXPERIMENTAL

BMS-986231

Intervention Type DRUG

BMS-986231 Placebo

Intervention Type DRUG

Panel 2 Arm

BMS-986231 and BMS-986231 Placebo intravenously

Group Type EXPERIMENTAL

BMS-986231

Intervention Type DRUG

BMS-986231 Placebo

Intervention Type DRUG

Panel 3 Arm

BMS-986231 and BMS-986231 Placebo intravenously

Group Type EXPERIMENTAL

BMS-986231

Intervention Type DRUG

BMS-986231 Placebo

Intervention Type DRUG

Interventions

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BMS-986231

Intervention Type DRUG

BMS-986231 Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ancestry

* First generation Japanese
* Non-Asian with grandparents and parents of non-Asian descent
* Body weight greater than or equal to 45kg and less than or equal to 110kg
* Women of childbearing potential have specific birthcontrol methods
* Males sexually active with women of childbearing potential have specific birthcontrol methods

Exclusion Criteria

* History of chronic illness
* Chronic headaches
* Recurrent dizziness
* Personal or family history of heart disease
* Personal history of bleeding diathesis
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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West Coast Clinical Trials, Llc

Cypress, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV013-018

Identifier Type: -

Identifier Source: org_study_id

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