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BMS-986419

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 ParticipantsPHASE1 COMPLETED 74 — — Feb 27, 2025Oct 21, 2025Nov 17, 20251 United States
NCT05932277A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy ParticipantsPHASE1 COMPLETED 22 — — Jun 29, 2023Sep 13, 2023Oct 30, 20231 United States
NCT05847439A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male ParticipantsPHASE1 COMPLETED 8 — — May 5, 2023Jul 5, 2023Oct 2, 20231 United States
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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 — 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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