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

A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function

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

Study Overview

• Status: Completed
• Conditions: Cardiac Failure; Myocardial Failure
• Intervention / Treatment: Drug: BMS-986224

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Prism Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Renal Impairment	Drug: BMS-986224; Specified dose on specified days
Experimental: Moderate Renal Impairment	Drug: BMS-986224; Specified dose on specified days
Experimental: Severe Renal Impairment	Drug: BMS-986224; Specified dose on specified days
Experimental: Normal Renal Function	Drug: BMS-986224; Specified dose on specified days
Experimental: End-Stage Renal Disease (ESRD); ESRD participants and are on chronic hemodialysis	Drug: BMS-986224; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) 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
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 extrapolated to infinite time [AUC(INF)] of BMS-986224		Up to 11 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224		Up to 11 days
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
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	Part 1 only	7 days
Fraction of dose excreted in urine (Fe%) of BMS-986224	Part 1 only	7 days
Renal clearance of BMS-986224 derived from urine concentration	Part 1 only	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CV016-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No