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BMS-986369

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Last Updated: Jan 23, 2026

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 Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06535399Study to Assess Drug Levels and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Different Degrees of Hepatic ImpairmentPHASE1 COMPLETED 29 — — Aug 15, 2024Nov 12, 2025Jan 23, 20263 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax)
Up to approximately 44 days
Time of maximum observed plasma concentration (Tmax)
Up to approximately 44 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Up to approximately 44 days
Secondary Endpoints
Incidence of adverse events (AEs)
Up to approximately 44 days
Incidence of serious adverse events (SAEs)
Up to approximately 44 days
Number of participants with physical examination abnormalities
Up to approximately 44 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group A: BMS-986369 Moderate Hepatic ImpairmentEXPERIMENTAL -
Group B: BMS-986369 Severe Hepatic ImpairmentEXPERIMENTAL -
Group C: BMS-986369 Normal Hepatic FunctionEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986369DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria for all Participants (Group A, Group B, Group C): * Body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg. Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B): * Participants have moderate HI (Group...

Countries:United States
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