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BMS-986533

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jul 24, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986533 · 1 trial · 1 indication

Phase 1 1
NCT07629999Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy ParticipantsHealthy Volunteers
RECRUITING136 Analytics
PHASE1RECRUITING
Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants
Healthy Volunteers
NCT07629999136
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Study Endpoints

Primary Endpoints

Number of participants with Adverse Events (AE)
Up to Day 47
Number of participants with Serious Adverse Events (SAE)
Up to Day 47
Number of participants with Vital Sign Abnormalities
Up to Day 27
Number of participants with Physical Examination Abnormalities
Up to Day 27

Including neurological examination

Number of participants with Electrocardiogram (ECG) Abnormalities
Up to Day 27
Number of participants with Clinical Laboratory Assessments Abnormalities
Up to Day 27
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to Day 27

Secondary Endpoints

Maximum observed concentration (Cmax)
Up to Day 26 from last dose
Time of maximum observed concentration (Tmax)
Up to Day 26 from last dose
Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Up to Day 26 from last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986533DRUGSpecified dose on specified days
FamotidineDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
Dabigatran EtexilateDRUGSpecified dose on specified days
RosuvastatinDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg. * Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status. * A male (as assigned at birth) ...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJul 24, 2026NCT07629999Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 24, 2026NCT07629999Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about BMS-986533

What is BMS-986533 used for?

BMS-986533 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a trial evaluating its safety, pharmacokinetics, food and pH effects on relative bioavailability, and drug-drug interaction potential. The drug is not approved and remains in clinical testing.

Who makes BMS-986533?

BMS-986533 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 clinical trial of the drug in healthy participants in the United States.

What phase is BMS-986533 in?

BMS-986533 is in Phase 1 clinical development. The ongoing trial is a single and multiple dose study in healthy participants, designed to evaluate safety, pharmacokinetics, food and pH effects, and drug-drug interaction potential. The drug is investigational and not yet approved.

What clinical trials is BMS-986533 in?

BMS-986533 is being studied in one Phase 1 clinical trial, registered as NCT07629999. This randomized, double-blind, controlled study enrolls 136 healthy participants aged 18 years and older in the United States. The trial is currently recruiting and evaluates safety, pharmacokinetics, food and pH effects, and drug-drug interactions.

Is BMS-986533 FDA approved?

BMS-986533 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing trial is recruiting healthy volunteers to assess the drug's safety, pharmacokinetics, and other characteristics. Approval status has not been established.