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BMS-986419 DR

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Jan 23, 2024

BMS-986419 DR target and mechanism

ModalitySmall molecule

Also known as BMS-986419 DR Capsule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

BMS-986419 DR clinical trials

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 VolunteersUnlock trial analytics

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?

BMS-986419 DR is an investigational small molecule drug developed by Bristol-Myers Squibb Company (ticker: BMY). It is also known as BMS-986419 DR Capsule. The drug is in Phase 1 clinical development, and its intended therapeutic indication has not been disclosed.

Who makes BMS-986419 DR?

BMS-986419 DR is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. Bristol-Myers Squibb is the sponsor of the clinical trial evaluating this drug candidate.

What phase is BMS-986419 DR in?

BMS-986419 DR is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this drug candidate.

What clinical trials is BMS-986419 DR in?

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

Is BMS-986419 DR the same as BMS-986419 DR Capsule?

Yes, BMS-986419 DR Capsule is an alternative name for BMS-986419 DR. Both names refer to the same investigational small molecule developed by Bristol-Myers Squibb Company. The completed Phase 1 trial NCT05963932 evaluated an immediate-release tablet formulation of BMS-986419.