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BMS-986224

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986224 · 2 trials · 3 indications

Phase 1 2
NCT03634969An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired ParticipantsCardiac Failure
COMPLETED50 Analytics
NCT03563950An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy ParticipantsHealthy Participants
COMPLETED42 Analytics
PHASE1COMPLETED
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants
Cardiac FailureUnlock trial analytics
PHASE1COMPLETED
An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants
Healthy ParticipantsUnlock 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
Rifampin + BMS-986224EXPERIMENTALOral administration

Interventions

NameTypeDescription
BMS-986224DRUGSpecified dose on specified days
RifampinDRUGSpecified 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 used for?

BMS-986224 is an investigational small molecule being developed by Bristol-Myers Squibb for cardiovascular conditions, specifically studied in healthy participants and in participants with cardiac failure or myocardial failure. It is currently in Phase 1 clinical development and is not approved by the FDA.

What does BMS-986224 target?

The molecular target of BMS-986224 has not been disclosed in available clinical trial information. The drug is being studied for its effects in cardiovascular conditions, but its specific mechanism of action is not publicly detailed.

Who makes BMS-986224?

BMS-986224 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy participants and in those with cardiac failure.

What phase is BMS-986224 in?

BMS-986224 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in the United States, with a total enrollment of 50 participants. The drug is investigational and has not received FDA approval.

What clinical trials is BMS-986224 in?

BMS-986224 has two completed Phase 1 trials: NCT03563950, a study of the effect of rifampin on a single dose of BMS-986224 in healthy participants (enrollment 42), and NCT03634969, a study of BMS-986224 in renally impaired participants with cardiac failure or myocardial failure (enrollment 50).

Is BMS-986224 the same as any other drug?

No alternative names for BMS-986224 have been disclosed. The drug is identified solely by its development code BMS-986224 in clinical trial registrations and is not known to be marketed under any other name.