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BMS-986371

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 8, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05445440A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of SulfasalazinePHASE1 COMPLETED 30Sep 6, 2022Nov 23, 2022Feb 8, 20231 United States
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Up to 22 days

Part 1

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 22 days

Part 1

Maximum observed plasma concentration (Cmax)
Up to 22 days

Part 1

Secondary Endpoints
AUC(0-T)
Up to 22 days
AUC(INF)
Up to 22 days
Cmax
Up to 22 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Interventions
NameTypeDescription
MethotrexateDRUGSpecified dose on specified days
LeucovorinDRUGSpecified dose on specified days
BMS-986371DRUGSpecified dose on specified days
SulfasalazineDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol * Body mass index of 18 to 32 kg...

Countries:United States
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