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BMS-986172

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jun 6, 2022

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
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04926051A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 AbsorptionPHASE1 COMPLETED 40 — — Jun 15, 2021Dec 28, 2021Jun 6, 20221 United States
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Study Endpoints
Primary Endpoints
Incidence of non-serious Adverse Events (AEs)
Up to 35 days
Incidence of Serious Adverse Events (SAEs)
Up to 35 days
Incidence of AEs leading to discontinuation of study treatment
Up to 35 days
Incidence of clinically significant changes in vital signs: Body temperature
Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure
Up to 28 days
Incidence of clinically significant changes in vital signs: Heart rate
Up to 28 days
Incidence of clinically significant changes in physical examination
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Serology tests
Up to 28 days
Incidence of clinically significant changes in ECG parameters: QTcF
Up to 28 days

QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

Secondary Endpoints
Plasma concentrations of BMS-986172
Up to 28 days
Maximum observed plasma concentration (Cmax)
Up to 28 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Up to 28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A: SADEXPERIMENTALSAD = Single Ascending Dose
Part B: MADEXPERIMENTALMAD = Multiple Ascending Dose
Part C: JMADEXPERIMENTALJMAD= Japanese Multiple Ascending Dose
Part D: FE/BAEXPERIMENTALFE/BA = Food Effect/Relative Bioavailability
Interventions
NameTypeDescription
BMS-986172DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee. * Participants in Part C must be first-generation Ja...

Countries:United States
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