An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants

NCT ID: NCT03634969

Last Updated: 2020-02-25

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2019-04-30

Brief Summary

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The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.

Detailed Description

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Conditions

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Cardiac Failure Myocardial Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal Renal Function

Group Type EXPERIMENTAL

BMS-986224

Intervention Type DRUG

Specified dose on specified days

Mild Renal Impairment

Group Type EXPERIMENTAL

BMS-986224

Intervention Type DRUG

Specified dose on specified days

Moderate Renal Impairment

Group Type EXPERIMENTAL

BMS-986224

Intervention Type DRUG

Specified dose on specified days

Severe Renal Impairment

Group Type EXPERIMENTAL

BMS-986224

Intervention Type DRUG

Specified dose on specified days

End-Stage Renal Disease (ESRD)

ESRD participants and are on chronic hemodialysis

Group Type EXPERIMENTAL

BMS-986224

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986224

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI ≥18 and ≤ 35kg/m2
* Systolic blood pressure \>100 mmHg

Exclusion Criteria

* Women of childbearing potential or women who are currently pregnant
* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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Clinical Pharmacology of Miami

Miami, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Prism Research

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV016-010

Identifier Type: -

Identifier Source: org_study_id

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