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BMS-986419 DR

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986419 DR · 1 trial · 1 indication

Phase 1 1
NCT05963932A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult ParticipantsHealthy Volunteers
COMPLETED60 Analytics
PHASE1COMPLETED
A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants
Healthy Volunteers
NCT0596393260
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax)
Up to 15 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Up to 15 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 15 days

Secondary Endpoints

Number of participants with adverse events (AEs)
Up to 29 days
Number of participants with vital sign abnormalities
Up to 29 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to 29 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment A: BMS-986419 DR Capsule - FastedEXPERIMENTAL -
Treatment B: BMS-986419 IR Tablet - FastedEXPERIMENTAL -
Treatment C: BMS-986419 IR Tablet - FedEXPERIMENTAL -
Treatment D: BMS-986419 Crushed IR Tablet - FedEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986419 DR CapsuleDRUGSpecified dose on specified days
BMS-986419 IR TabletDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations. * Body mass index (BMI) of 18.0 to 32.0 kilogr...

Countries:United States
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Frequently asked questions about BMS-986419 DR

What is BMS-986419 DR used for?

BMS-986419 DR is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing the bioavailability and effect of food of its immediate-release tablet formulation. The drug is not approved for any indication and remains in early-stage clinical testing.

Who makes BMS-986419 DR?

BMS-986419 DR is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's properties in healthy adult participants.

What phase is BMS-986419 DR in?

BMS-986419 DR is in Phase 1 clinical development. One Phase 1 trial has been completed, which studied the drug's bioavailability and the effect of food on its immediate-release tablet formulation in healthy adult participants. The drug is investigational and has not received regulatory approval.

What clinical trials is BMS-986419 DR in?

BMS-986419 DR has one completed clinical trial registered under NCT05963932, titled "A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants." This Phase 1 study enrolled 60 healthy volunteers in the United States and was a controlled, randomized trial.

Is BMS-986419 DR FDA approved?

BMS-986419 DR is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial has evaluated its immediate-release tablet formulation in healthy volunteers, but the drug has not yet progressed through the later stages of clinical testing required for regulatory approval.