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BMS-986209

Phase 1

Health Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 4, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04154800A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy ParticipantsPHASE1 COMPLETED 114 — — Dec 6, 2019Aug 31, 2021Jan 4, 20221 United States
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs) including bleeding
Up to 18 days
Incidence of serious AEs (SAEs)
Up to 44 days
Incidence of AEs leading to discontinuation
Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Up to 16 days
Secondary Endpoints
Maximum observed plasma concentration (Cmax) of BMS-986209
Up to 18 days
Time of Maximum observed plasma concentration (Tmax) of BMS-986209
Up to 18 days
Terminal plasma half-life (T-Half) of BMS-986209
Up to 18 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A:SADEXPERIMENTALSingle Ascending Dose
Part B: MADEXPERIMENTALMultiple Ascending Dose
Part C: DDIEXPERIMENTALDrug-Drug Interaction
Part A (SAD) PlaceboEXPERIMENTAL -
Part B (MAD) PlaceboEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986209DRUGSpecified Dose on Specified Days
BMS-986209 PlaceboOTHERSpecified Dose on Specified Days
ItraconazoleDRUGSpecified Dose on Specified Days
DiltiazemDRUGSpecified Dose on Specified Days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in...

Countries:United States
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