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BMS-986278 Batched method, Dose A

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Apr 4, 2025

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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06715683A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy ParticipantsPHASE1 COMPLETED 48Dec 12, 2024Mar 16, 2025Apr 4, 20251 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax)
Up to Day 24
Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T))
Up to Day 24
Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF))
Up to Day 24
Secondary Endpoints
Time of Maximum Observed Plasma Concentration (Tmax)
Up to Day 24
Terminal Phase Half-life (T-HALF)
Up to Day 24
Apparent Total Body Clearance (CLT/F)
Up to Day 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1, Sequence 1EXPERIMENTAL -
Part 1, Sequence 2EXPERIMENTAL -
Part 2, Sequence 1EXPERIMENTAL -
Part 2, Sequence 2EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986278 Batched method, Dose ADRUGSpecified dose on specified days
BMS-986278 Batched method, Dose BDRUGSpecified dose on specified days
BMS-986278 Continuous methodDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator. * Body mass ...

Countries:United States
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