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BMS-986419 DR

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 23, 2024

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05963932A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult ParticipantsPHASE1 COMPLETED 60 — — Aug 8, 2023Oct 17, 2023Jan 23, 20241 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax)
Up to 15 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Up to 15 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 15 days
Secondary Endpoints
Number of participants with adverse events (AEs)
Up to 29 days
Number of participants with vital sign abnormalities
Up to 29 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to 29 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A: BMS-986419 DR Capsule - FastedEXPERIMENTAL -
Treatment B: BMS-986419 IR Tablet - FastedEXPERIMENTAL -
Treatment C: BMS-986419 IR Tablet - FedEXPERIMENTAL -
Treatment D: BMS-986419 Crushed IR Tablet - FedEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986419 DR CapsuleDRUGSpecified dose on specified days
BMS-986419 IR TabletDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations. * Body mass index (BMI) of 18.0 to 32.0 kilogr...

Countries:United States
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