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BMS-963272

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

BMS-963272 · 3 trials · 3 indications

Phase 1 3
NCT04124003A Study to Assess the Drug-drug Interaction of BMS-963272 and RosuvastatinHealthy Participants
COMPLETED28 Analytics
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
NCT02327273Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy SubjectsHealthy
COMPLETED88 Analytics
PHASE1COMPLETED
A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin
Healthy Participants
NCT0412400328
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PHASE1COMPLETED
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Obese But Otherwise Healthy Participants
NCT0411663236
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PHASE1COMPLETED
Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
Healthy
NCT0232727388
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Study Endpoints

Primary Endpoints

Maximum concentration (Cmax)
up to Day 10
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)
up to Day 10
Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)
up to Day 10
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
Safety and tolerability of single oral dose of BMS-963272 in healthy overweight and obese subjects is measured by adverse events, Serious adverse events, vital signs, laboratory assessments and ECG
Up to 10 days
Safety and tolerability of multiple oral doses of BMS-963272 in healthy overweight and obese subjects is measured by adverse events, Serious adverse events, vital signs, laboratory assessments and ECG
With in 18 days

Secondary Endpoints

Incidence of Adverse Events (AEs)
Approximately 50 days
Number of significant changes in lab assessments of blood serum
Approximately 50 days
Number of significant changes in lab assessments of blood
Approximately 50 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
rosuvastatin + BMS-963272EXPERIMENTAL -
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 -
Part A SAD: BMS-963272 or PlaceboEXPERIMENTALBMS-963272 or Placebo oral capsule on specific days
Part B MAD: BMS-963272 or PlaceboEXPERIMENTALBMS-963272 or Placebo oral capsule on specific days

Interventions

NameTypeDescription
rosuvastatinDRUGSpecified dose on specified days
BMS-963272DRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about BMS-963272

What is BMS-963272 used for?

BMS-963272 is an investigational small molecule being studied in healthy participants and in obese but otherwise healthy adults. It is in Phase 1 clinical development by Bristol-Myers Squibb. The drug is being evaluated for safety, tolerability, and pharmacokinetics, though its specific therapeutic indication has not been established.

Who makes BMS-963272?

BMS-963272 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has conducted Phase 1 clinical trials of the drug in the United States, focusing on healthy volunteers and obese but otherwise healthy adults.

What phase is BMS-963272 in?

BMS-963272 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three of its clinical trials, which studied safety, tolerability, and pharmacokinetics, have been completed.

What clinical trials is BMS-963272 in?

BMS-963272 has completed three Phase 1 trials: NCT02327273, a randomized, placebo-controlled, double-blind, ascending single and multiple dose study in healthy subjects; NCT04116632, a multiple dose study in obese but otherwise healthy adults; and NCT04124003, a drug-drug interaction study with rosuvastatin in healthy participants.

Is BMS-963272 the same as any other drug?

No alternative names for BMS-963272 have been disclosed. The drug is identified solely by its development code BMS-963272 in clinical trial registrations and is being studied as a monotherapy in early-stage trials.