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BMS-986165 formulation 1

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 11, 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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04305899A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult ParticipantsPHASE1 COMPLETED 40 — — Aug 31, 2020Nov 25, 2020Nov 11, 20211 United States
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Study Endpoints
Primary Endpoints
Maximum concentration (Cmax) in plasma for BMS-986165
Up to 26 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165
Up to 26 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165
Up to 26 days
Secondary Endpoints
Incidence of Adverse Events (AEs)
Up to 26 days
Incidence of Serious Adverse Events (SAEs)
Up to 98 days
Incidence of clinically significant changes in physical examination findings
Up to 68 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment Group 1EXPERIMENTAL -
Treatment Group 2EXPERIMENTAL -
Treatment Group 3EXPERIMENTAL -
Treatment Group 4EXPERIMENTAL -
Treatment Group 5EXPERIMENTAL -
Treatment Group 6EXPERIMENTAL -
Treatment Group 7EXPERIMENTAL -
Treatment Group 8EXPERIMENTAL -
Treatment Group 9EXPERIMENTAL -
Treatment Group 10EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986165 Tablet formulation 1DRUGSpecified dose on specified days
BMS-986165 Tablet formulation 2DRUGSpecified 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 participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laborator...

Countries:United States
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