Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants

NCT ID: NCT03210909

Last Updated: 2017-08-01

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-22

Study Completion Date

2017-07-20

Brief Summary

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An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231

Detailed Description

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Conditions

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Heart Decompensation, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986231 Intravenous Infusion

A single continuous intravenous infusion of BMS-986231

Group Type EXPERIMENTAL

BMS-986231

Intervention Type DRUG

BMS-986231

Interventions

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BMS-986231

BMS-986231

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent
* Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
* Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.

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

50 Years

Eligible Sex

MALE

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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Covance Clinical Research Unit

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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CV013-022

Identifier Type: -

Identifier Source: org_study_id

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