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BMS-963272

Phase 1

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

BMS-963272 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Dec 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

BMS-963272 clinical trials

BMS-963272 · 1 trial · 1 indication

Phase 1 1
NCT04116632A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy AdultsObese But Otherwise Healthy Participants
COMPLETED36 Analytics
PHASE1COMPLETED
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Obese But Otherwise Healthy ParticipantsUnlock trial analytics

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 to 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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Frequently asked questions about BMS-963272

What is BMS-963272?

BMS-963272 is an investigational small molecule developed by Bristol-Myers Squibb for metabolic research. It was studied in obese but otherwise healthy adult participants. The compound has been evaluated in a single Phase 1 clinical trial, which is now completed.

What is BMS-963272 used for?

BMS-963272 was studied in obese but otherwise healthy adult participants, a metabolic research setting. It is an investigational agent and is not an approved treatment. Its only recorded clinical trial enrolled 36 participants and has been completed.

Who makes BMS-963272?

Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of BMS-963272. The company sponsored the Phase 1 study of the compound in obese but otherwise healthy adults.

What phase is BMS-963272 in?

BMS-963272 is in Phase 1 development. It is an investigational small molecule and has not been approved for any indication. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is BMS-963272 in?

BMS-963272 was evaluated in one clinical trial, NCT04116632, titled A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults. The Phase 1 trial enrolled 36 participants in the United States and is completed.

How was the BMS-963272 Phase 1 trial designed?

NCT04116632 was a Phase 1 multiple dose study of BMS-963272 in obese but otherwise healthy adults. It was randomized, double blind, and controlled, enrolling 36 participants aged 18 years and older in the United States. The trial is completed.