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

Phase 1

Completed

• Conditions: Cardiac Failure; Myocardial Failure
• Interventions: Drug: BMS-986224

• Registration Number: NCT03634969
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-08-14
• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Renal Impairment	BMS-986224	-
Severe Renal Impairment	BMS-986224	-
Normal Renal Function	BMS-986224	-
Mild Renal Impairment	BMS-986224	-
End-Stage Renal Disease (ESRD)	BMS-986224	ESRD participants and are on chronic hemodialysis

Primary Outcome Measures

Name	Time	Method
Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration	Up to 11 days
Fraction of unbound drug in plasma (fu) of BMS-986224	Up to 11 days
Maximum observed plasma concentration (Cmax) of BMS-986224	Up to 11 days
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224	Up to 11 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224	Up to 11 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224	Up to 11 days
Fraction of dose excreted in urine (Fe%) of BMS-986224	7 days	Part 1 only
Renal clearance of BMS-986224 derived from urine concentration	7 days	Part 1 only
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224	Up to 11 days
Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration	Up to 11 days
Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration	Up to 11 days
Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224	7 days	Part 1 only

Secondary Outcome Measures

Name	Time	Method
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation	Up to 41 days
Maximum observed plasma concentration (Cmax) of metabolite	Up to 11 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite	Up to 11 days
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite	Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite	Up to 11 days
Time of maximum observed plasma concentration (Tmax) of metabolite	Up to 11 days
Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration	Up to 11 days
Metabolite-to-parent (MR) ratio for cMax	Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(0-T)	Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(0-72)	Up to 11 days
Metabolite-to-parent (MR) ratio for AUC(INF)	Up to 11 days
Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests	Up to 11 days

Trial Locations

Locations (3)

Prism Research; 🇺🇸 Saint Paul, Minnesota, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States