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BMS-963272

Phase 1

Obese But Otherwise Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 15, 2020

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04116632A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy AdultsPHASE1 COMPLETED 36 — — Sep 30, 2019Feb 10, 2020May 15, 20201 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration of BMS-963272 (Cmax)
Day 1, Day 14
Time of maximum observed concentration of BMS-963272 (Tmax)
Day 1, Day 14
Area under the concentration-time curve in one dosing interval (AUC(TAU))
Day 1, Day 14
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Day 14
Apparent total clearance of the drug from plasma after oral administration (CLss/F)
Day 14
Apparent volume of distribution at steady state (Vss/F)
Day 14
Average concentration at steady state (Cavg,ss)
Day 14
Half-life (T-HALF)
Day 14
Accumulation index (AI)
Day 14
Rate elimination constant (kel) of BMS-963272
Day 14
Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)
Day 7, Day 15
Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT
Day 7, Day 15
Secondary Endpoints
Incidence of Adverse Events (AEs)
Up to 55 days
Incidence of Serious Adverse Events (SAEs)
Up to 55 days
Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests
Up to 55 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-963272 or Placebo once daily (QD)EXPERIMENTAL -
BMS-963272 or Placebo every 12 hours (Q12H)EXPERIMENTAL -
BMS-963272 or Placebo every 8 hours (Q8H)EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-963272DRUGSingle dose with varying frequency among groups
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, phy...

Countries:United States
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