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BMS-986224

Phase 1

Cardiac Failure | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Trials Updated: Feb 25, 2020

BMS-986224 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Sep 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

BMS-986224 clinical trials

BMS-986224 · 1 trial · 2 indications

Phase 1 1
NCT03634969An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired ParticipantsCardiac Failure
COMPLETED50 Analytics
PHASE1COMPLETED
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
Cardiac FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

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
7 days

Part 1 only

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Normal Renal FunctionEXPERIMENTAL -
Mild Renal ImpairmentEXPERIMENTAL -
Moderate Renal ImpairmentEXPERIMENTAL -
Severe Renal ImpairmentEXPERIMENTAL -
End-Stage Renal Disease (ESRD)EXPERIMENTALESRD participants and are on chronic hemodialysis

Interventions

NameTypeDescription
BMS-986224DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites3

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 * Clin...

Countries:United States
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Frequently asked questions about BMS-986224

What is BMS-986224?

BMS-986224 is an investigational small molecule being developed by Bristol-Myers Squibb Company for cardiac failure. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not an approved therapy and remains under clinical evaluation for cardiovascular use.

What is BMS-986224 used for?

BMS-986224 is being evaluated for cardiac failure, including myocardial failure. Its only recorded clinical study enrolled renally impaired participants, a population often studied alongside heart failure. The drug is investigational, so it has no approved use outside of clinical research.

Who makes BMS-986224?

BMS-986224 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of the compound in renally impaired participants conducted in the United States.

What phase is BMS-986224 in?

BMS-986224 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The compound has not been approved by the FDA and remains an investigational agent for cardiac failure.

What clinical trials is BMS-986224 in?

BMS-986224 has been studied in one completed Phase 1 trial, NCT03634969, titled an investigational study to evaluate experimental medication BMS-986224 in renally impaired participants. It enrolled 50 participants in the United States, included healthy volunteers, and used a controlled design without randomization or double blinding.