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Prototype BMS-986165

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Oct 6, 2021

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04536961A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy ParticipantsPHASE1 COMPLETED 56 — — Sep 10, 2020Dec 25, 2020Oct 6, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of BMS-986165
Day 1 and Day 7
Time of maximum observed plasma concentration (Tmax) of BMS-986165
Day 1 and Day 7
Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165
Day 1 and Day 7

Part A, B, C

Secondary Endpoints
Incidence of Nonserious Adverse Events (AEs)
Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)
Incidence of Serious Adverse Events (AEs)
Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Reference TreatmentEXPERIMENTAL -
Part A PrototypeEXPERIMENTAL -
Part C Reference TreatmentEXPERIMENTAL -
Part C: PrototypeEXPERIMENTAL -
Part B: Treatment 1EXPERIMENTAL -
Part B: Treatment 2EXPERIMENTAL -
Part B: Treatment 3EXPERIMENTAL -
Part B: Treatment 4EXPERIMENTAL -
Part B: Treatment 5EXPERIMENTAL -
Interventions
NameTypeDescription
Reference Treatment- BMS-986165-01DRUGSpecified dose on specified days
Prototype BMS-986165DRUGSpecified dose on specified days
FamotidineDRUGSpecified dose on specified days
AlcoholOTHERSpecified quantity 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: * No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations. ...

Countries:United Kingdom
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