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BMS-986172

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jun 6, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986172 · 1 trial · 1 indication

Phase 1 1
NCT04926051A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 AbsorptionHealthy Participants
COMPLETED40 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of non-serious Adverse Events (AEs)
Up to 35 days
Incidence of Serious Adverse Events (SAEs)
Up to 35 days
Incidence of AEs leading to discontinuation of study treatment
Up to 35 days
Incidence of clinically significant changes in vital signs: Body temperature
Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure
Up to 28 days
Incidence of clinically significant changes in vital signs: Heart rate
Up to 28 days
Incidence of clinically significant changes in physical examination
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Serology tests
Up to 28 days
Incidence of clinically significant changes in ECG parameters: QTcF
Up to 28 days

QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

Secondary Endpoints

Plasma concentrations of BMS-986172
Up to 28 days
Maximum observed plasma concentration (Cmax)
Up to 28 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Up to 28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: SADEXPERIMENTALSAD = Single Ascending Dose
Part B: MADEXPERIMENTALMAD = Multiple Ascending Dose
Part C: JMADEXPERIMENTALJMAD= Japanese Multiple Ascending Dose
Part D: FE/BAEXPERIMENTALFE/BA = Food Effect/Relative Bioavailability

Interventions

NameTypeDescription
BMS-986172DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee. * Participants in Part C must be first-generation Ja...

Countries:United States
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Frequently asked questions about BMS-986172

What is BMS-986172 used for?

BMS-986172 is an investigational small molecule being studied in healthy participants. It is being evaluated for safety, tolerability, and drug levels, including the effects of food on its absorption. It is not approved for any condition and is in Phase 1 clinical development.

Who makes BMS-986172?

BMS-986172 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting a Phase 1 study to assess the drug's safety, tolerability, and pharmacokinetics in healthy and obese participants.

What phase is BMS-986172 in?

BMS-986172 is in Phase 1 clinical development. The only trial listed for this drug is a Phase 1 study that has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BMS-986172 in?

BMS-986172 has one completed Phase 1 clinical trial, identified as NCT04926051. This study assessed the safety, tolerability, and drug levels of BMS-986172 in healthy and obese participants, including the effects of food on absorption. The trial was conducted in the United States with 40 participants.

Is BMS-986172 FDA approved?

BMS-986172 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on safety, tolerability, and drug levels in healthy participants, and the drug has not yet progressed to later-stage trials or regulatory approval.