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BMS-986224

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03634969An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired ParticipantsPHASE1 COMPLETED 50 — — Aug 14, 2018Apr 30, 2019Feb 25, 20203 United States
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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 — 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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