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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cardiac Failure; Myocardial Failure

Treatments: Drug: BMS-986224

Study type: Interventional

Funder types: Industry

Identifiers

NCT03634969

CV016-010

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

Normal Renal Function

Experimental group

Treatment:

Drug: BMS-986224

Mild Renal Impairment

Experimental group

Treatment:

Drug: BMS-986224

Moderate Renal Impairment

Experimental group

Treatment:

Drug: BMS-986224

Severe Renal Impairment

Experimental group

Treatment:

Drug: BMS-986224

End-Stage Renal Disease (ESRD)

Experimental group

Description:

ESRD participants and are on chronic hemodialysis

Treatment:

Drug: BMS-986224