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BMS-986278 Batched method, Dose A

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Apr 4, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986278 Batched method, Dose A · 1 trial · 1 indication

Phase 1 1
NCT06715683A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy ParticipantsHealthy Volunteers
COMPLETED48 Analytics
PHASE1COMPLETED
A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Up to Day 24
Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T))
Up to Day 24
Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF))
Up to Day 24

Secondary Endpoints

Time of Maximum Observed Plasma Concentration (Tmax)
Up to Day 24
Terminal Phase Half-life (T-HALF)
Up to Day 24
Apparent Total Body Clearance (CLT/F)
Up to Day 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1, Sequence 1EXPERIMENTAL -
Part 1, Sequence 2EXPERIMENTAL -
Part 2, Sequence 1EXPERIMENTAL -
Part 2, Sequence 2EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986278 Batched method, Dose ADRUGSpecified dose on specified days
BMS-986278 Batched method, Dose BDRUGSpecified dose on specified days
BMS-986278 Continuous methodDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator. * Body mass ...

Countries:United States
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Frequently asked questions about BMS-986278 Batched method, Dose A

What is BMS-986278 used for?

BMS-986278 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its comparative bioavailability in healthy participants. The drug is not approved for any indication and remains in clinical testing.

Who makes BMS-986278?

BMS-986278 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.

What phase is BMS-986278 in?

BMS-986278 is in Phase 1 clinical development. A Phase 1 study has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is BMS-986278 in?

BMS-986278 has one completed Phase 1 clinical trial, NCT06715683, titled 'A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants.' The trial enrolled 48 participants in the United States and was a controlled, randomized study.

Is BMS-986278 FDA approved?

BMS-986278 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy volunteers is part of early-stage research, and the drug has not yet received marketing approval.