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BMS-986419

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Nov 17, 2025

BMS-986419 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since May 2023

BMS-986419 target and mechanism

ModalitySmall molecule

Also known as [14C]BMS-986419, EOAI4018683

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment104

FDA Designations

No designations recorded

BMS-986419 clinical trials

BMS-986419 · 3 trials · 1 indication

Phase 1 3
NCT06846866A Study to Investigate the Safety, Tolerability, and Drug Levels of BMS-986419 (Part 1) and the Effects Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy ParticipantsHealthy Volunteers
COMPLETED74 Analytics
NCT05932277A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy ParticipantsHealthy Volunteers
COMPLETED22 Analytics
NCT05847439A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male ParticipantsHealthy Volunteers
COMPLETED8 Analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, and Drug Levels of BMS-986419 (Part 1) and the Effects Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants
Healthy Volunteers
NCT0684686674
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PHASE1COMPLETED
A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
Healthy Volunteers
NCT0593227722
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PHASE1COMPLETED
A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
Healthy Volunteers
NCT058474398
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Study Endpoints

Primary Endpoints

Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)
Up to approximately Day 42
Part 1: Number of Participants with Serious Adverse Events (SAEs)
Up to approximately Day 42
Part 1: Number of Participants with AEs Leading to Discontinuation
Up to approximately Day 42
Part 1: Number of Participants With AEs of Special Interest (AESI)
Up to approximately Day 42
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
Up to approximately Day 21

Vital sign parameters include temperature, systolic blood pressure (BP), diastolic BP, respiratory rate, and heart rate (HR) assessment.

Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities
Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities
Up to approximately Day 21
Part 1: Number of Participants With Physical Examination Abnormalities
Up to approximately Day 21
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QT interval (QTc)
Up to approximately Day 15

ΔQTc is performed by primary correction.

Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QTc
Up to approximately Day 15
Maximum observed plasma concentration (Cmax)
Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to Day 25
Time of maximum plasma observed concentration (Tmax)
Up to Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Up to Day 20
Total radioactivity recovered in urine (UR)
Up to Day 30
Total radioactivity recovered in feces (FR)
Up to Day 30
Total radioactivity recovered in bile (BR)
Up to Day 30
Total radioactivity recovered (Rtotal)
Up to Day 30
Percent of total radioactivity recovered (%Total)
Up to Day 30
Percent of total radioactivity recovered in urine (%UR)
Up to Day 30
Percent of total radioactivity recovered in feces (%FR)
Up to Day 30

Secondary Endpoints

Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986419
Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986419
Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-986419
Up to approximately Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Administration of BMS-986419EXPERIMENTAL -
Part 1: Administration of PlaceboPLACEBO_COMPARATOR -
Part 2: Group 1EXPERIMENTAL -
Part 2: Group 2aEXPERIMENTAL -
Part 2: Group 2bEXPERIMENTAL -
Cocktail Probe Substrates + BMS-986419EXPERIMENTAL -
[14C]BMS-986419EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986419DRUGSpecified dose on specified days
BMS-986419 Matching PlaceboDRUGSpecified dose on specified days
MoxifloxacinDRUGSpecified dose on specified days
Moxifloxacin Matching PlaceboDRUGSpecified dose on specified days
CaffeineDRUGSpecified dose on specified days
BupropionDRUGSpecified dose on specified days
FlurbiprofenDRUGSpecified dose on specified days
OmeprazoleDRUGSpecified dose on specified days
MidazolamDRUGSpecified dose on specified days
FexofenadineDRUGSpecified dose on specified days
[14C]BMS-986419DRUGSpecified 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 be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments. * Participants must have a Body mass index (BMI) between 18.0 and 30.0 kilograms/meter square (kg/m\^2), inclusive, at screening. ...

Countries:United States
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Frequently asked questions about BMS-986419

What is BMS-986419?

BMS-986419 is an investigational small molecule being developed by Bristol-Myers Squibb Company. It is in Phase 1 clinical development, with studies conducted in healthy volunteers rather than in patients with a disclosed disease. The specific therapeutic indication for BMS-986419 has not been publicly disclosed.

Who makes BMS-986419?

BMS-986419 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. Bristol-Myers Squibb is the sponsor of the Phase 1 clinical trials evaluating BMS-986419 in healthy participants.

What phase is BMS-986419 in?

BMS-986419 is in Phase 1 clinical development. All three of its registered trials are Phase 1 studies, and all three are listed as completed. BMS-986419 is investigational and has not been approved by the FDA for any indication.

What clinical trials is BMS-986419 in?

BMS-986419 has been evaluated in three completed Phase 1 trials: NCT06846866, which assessed safety, tolerability, drug levels, and cardiac repolarization in 74 healthy participants; NCT05932277, which assessed drug interaction effects on probe substrates in 22 healthy participants; and NCT05847439, which evaluated absorption, metabolism, and excretion in 8 healthy male participants.

Is BMS-986419 the same as [14C]BMS-986419?

Yes, [14C]BMS-986419 is an alternative name for BMS-986419. The carbon-14 labeled form was used in trial NCT05847439, a Phase 1 study that evaluated the absorption, metabolism, and excretion of BMS-986419 in healthy male participants.

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