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BMS-986196

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Sep 26, 2023

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05852769A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy ParticipantsPHASE1 COMPLETED 18 — — May 31, 2023Aug 24, 2023Sep 26, 20231 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax)
Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 26 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Up to 26 days
Secondary Endpoints
Time of maximum observed serum concentration (Tmax)
Up to 26 days
Apparent terminal phase half-life (T-Half)
Up to 26 days
Apparent total body clearance (CLT/F)
Up to 26 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986196 and/or Cocktail Probe Substrate DrugsEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986196DRUGSpecified dose on specified days
CaffeineDRUGSpecified dose on specified days
MontelukastDRUGSpecified dose on specified days
FlurbiprofenDRUGSpecified dose on specified days
OmeprazoleDRUGSpecified dose on specified days
MidazolamDRUGSpecified dose on specified days
DigoxinDRUGSpecified dose on specified days
PravastatinDRUGSpecified 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 as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. * Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m\^2), inclusive, and ...

Countries:United States
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