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CompletedNCT06846866Updated Nov 17, 2025

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

A Phase 1 interventional study of BMS-986419 and BMS-986419 Matching Placebo in Healthy Volunteers, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) in healthy participants.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • BMS-986419, healthy, QTC, pharmacokinetics, moxifloxacin
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Exclusion criteria

Exclusion Criteria

  • Participants must not have any significant acute or chronic medical illness as determined by the investigator.
  • Participants must not have any current or recent (within 3 months of study intervention administration) GI disease, liver and kidney that could possibly affect drug absorption, distribution, metabolism, and excretion, (e.g., bariatric procedure, Cholecystectomy, and any other GI surgery that could impact upon the absorption of study intervention).
  • Participants must not have Gilbert Syndrome.
  • Participants must not have a history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias (e.g., long QT syndrome, catecholamine polymorphic ventricular tachycardia).
  • Participants must not have exposure to any investigational drug or placebo (other than BMS-986419 or moxifloxacin) within 4 weeks or 5 half-lives (whichever is longer) prior to Day -1 (Day -2 for Part 2) until follow-up phone call.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Part 1: Administration of BMS-986419

    Drug: BMS-986419

  • Placebo comparator
    Part 1: Administration of Placebo

    Drug: BMS-986419 Matching Placebo

  • Experimental
    Part 2: Group 1

    Drug: BMS-986419 · Drug: BMS-986419 Matching Placebo · Drug: Moxifloxacin Matching Placebo

  • Experimental
    Part 2: Group 2a

    Drug: BMS-986419 Matching Placebo · Drug: Moxifloxacin · Drug: Moxifloxacin Matching Placebo

  • Experimental
    Part 2: Group 2b

    Drug: BMS-986419 Matching Placebo · Drug: Moxifloxacin · Drug: Moxifloxacin Matching Placebo

Interventions

  • DrugBMS-986419

    Specified dose on specified days

  • DrugBMS-986419 Matching Placebo

    Specified dose on specified days

  • DrugMoxifloxacin

    Specified dose on specified days

  • DrugMoxifloxacin Matching Placebo

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)

    Time frame: Up to approximately Day 42

  2. Part 1: Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to approximately Day 42

  3. Part 1: Number of Participants with AEs Leading to Discontinuation

    Time frame: Up to approximately Day 42

  4. Part 1: Number of Participants With AEs of Special Interest (AESI)

    Time frame: Up to approximately Day 42

  5. Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities

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

    Time frame: Up to approximately Day 21

  6. Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Time frame: Up to approximately Day 21

  7. Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities

    Time frame: Up to approximately Day 21

  8. Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities

    Time frame: Up to approximately Day 21

  9. Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities

    Time frame: Up to approximately Day 21

  10. Part 1: Number of Participants With Physical Examination Abnormalities

    Time frame: Up to approximately Day 21

  11. Part 2: ΔQTc: Change From Baseline in Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QT interval (QTc)

    ΔQTc is performed by primary correction.

    Time frame: Up to approximately Day 15

  12. Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QTc

    Time frame: Up to approximately Day 15

Secondary outcomes

  1. Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986419

    Time frame: Up to approximately Day 21

  2. Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986419

    Time frame: Up to approximately Day 21

  3. Part 1: Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-986419

    Time frame: Up to approximately Day 21

  4. Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986419

    Time frame: Up to approximately Day 21

  5. Part 1: Terminal Phase Elimination Half-life (T-Half) of BMS-986419

    Time frame: Up to approximately Day 21

  6. Part 1: Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax) of BMS-986419

    Time frame: Up to approximately Day 21

  7. Part 1: Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)] of BMS-986419

    Time frame: Up to approximately Day 21

  8. Part 1: Apparent Total Body Clearance (CLT/F) of BMS-986419

    Time frame: Up to approximately Day 21

  9. Part 1: Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986419

    Time frame: Up to approximately Day 21

  10. Part 1: Trough Concentration of BMS-986419

    Time frame: Up to approximately Day 21

  11. Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Heart Rate (HR)(ΔHR) Correction

    Time frame: Up to approximately Day 15

  12. Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Pulse Rate (PR)(ΔPR) Correction

    Time frame: Up to approximately Day 15

  13. Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Respiratory Rate (RR) Interval Correction

    Time frame: Up to approximately Day 15

  14. Part 2: Change From Baseline of BMS-986419 in Quality Rating System (QRS) Interval (ΔQRS)

    Time frame: Up to approximately Day 15

  15. Part 2: Number of Participants With Treatment-emergent Values of Fridericia's Corrected QT interval (QTcF) for BMS-986419

    Participants with increase in absolute treatment-emergent QTc values \>450 and ≤480 milliseconds (msec), \>480 and ≤500 msec, or \>500 msec, and changes from pre-dose baseline of \>30 and ≤ 60 msec, or \>60 msec will be measured.

    Time frame: Up to approximately Day 15

  16. Part 2: Number of Timepoints With Change in Absolute Treatment-emergent QTcF Values for BMS-986419

    Number of timepoints with increase in absolute treatment-emergent QTc values \>450 and ≤480 milliseconds (msec), \>480 and ≤500 msec, or \>500 msec, and changes from pre-dose baseline of \>30 and ≤ 60 msec, or \>60 msec will be measured.

    Time frame: Up to approximately Day 15

  17. Part 2: Number of Participants With Treatment-emergent Values of Individualized Heart Rate-corrected Interval/Optimized HR-corrected QT Interval (QTcS/QTcI) for BMS-986419

    Time frame: Up to approximately Day 15

  18. Part 2: Number of Participants With Treatment-emergent Values of HR for BMS-986419

    Participants with decrease in HR from pre-dose baseline \>25% to a HR \<50 beats per minute (bpm); and increase in HR from pre-dose baseline \>25% to a HR \>100 bpm will be determined.

    Time frame: Up to approximately Day 15

  19. Part 2: Number of Timepoints With Change in Absolute Treatment-emergent HR Values for BMS-986419

    Number of timepoints with decrease in HR from pre-dose baseline \>25% to a HR \<50 beats per minute (bpm); and increase in HR from pre-dose baseline \>25% to a HR \>100 bpm will be determined.

    Time frame: Up to approximately Day 15

  20. Part 2: Number of Participants With Treatment-emergent Values of PR for BMS-986419

    Participants with increase in PR from pre-dose baseline \>25% to a PR\>200 msec will be determined.

    Time frame: Up to approximately Day 15

  21. Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent PR Values for BMS-986419

    Number of timepoints with increase in PR from pre-dose baseline \>25% to a PR\>200 msec will be determined.

    Time frame: Up to approximately Day 15

  22. Part 2: Number of Participants With Treatment-emergent Values of QRS for BMS-986419

    Participants with increase in QRS from pre-dose baseline \>25% to a QRS \>120 msec will be determined.

    Time frame: Up to approximately Day 15

  23. Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent QRS Values for BMS-986419

    Number of timepoints with increase in QRS from pre-dose baseline \>25% to a QRS \>120 msec will be determined.

    Time frame: Up to approximately Day 15

  24. Part 2: Number of Participants With New Onset ECG Morphology Findings

    "New" means an ECG finding that is not present on any baseline ECG \[that is, any ECG recorded prior to receipt of the first dose of study BMS-986419\] and becomes present on at least 1 on-treatment ECG during that treatment period).

    Time frame: Up to approximately Day 15

  25. Part 2: ΔQTc: Change From Baseline in Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QT interval (QTc)

    ΔQTc is performed by primary correction.

    Time frame: Up to approximately Day 15

  26. Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QTc

    Time frame: Up to approximately Day 15

  27. Part 2: Number of Participants with NSAEs

    Time frame: Up to approximately Day 36

  28. Part 2: Number of Participants with SAEs

    Time frame: Up to approximately Day 36

  29. Part 2: Number of Participants with AEs Leading to Discontinuation

    Time frame: Up to approximately Day 36

  30. Part 2: Number of Participants With AESI

    Time frame: Up to approximately Day 36

  31. Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities

    Vital sign parameters include temperature, systolic BP, diastolic BP, respiratory rate, and HR assessment.

    Time frame: Up to approximately Day 15

  32. Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

    Time frame: Up to approximately Day 14

  33. Part 2: Number of Participants With Clinically Significant 12-Lead ECG Abnormalities

    Time frame: Up to approximately Day 15

  34. Part 2: Number of Participants With Clinically Significant C-SSRS Abnormalities

    Time frame: Up to approximately Day 15

  35. Part 2: Number of Participants With Clinically Significant Neurological Examination Abnormalities

    Time frame: Up to approximately Day 15

  36. Part 2: Number of Participants With Physical Examination Abnormalities

    Time frame: Up to approximately Day 15

  37. Part 2: Cmax of BMS-986419

    Time frame: Up to approximately Day 15

  38. Part 2: Tmax of BMS-986419

    Time frame: Up to approximately Day 15

  39. Part 2: AUC(0-T) of BMS-986419

    Time frame: Up to approximately Day 15

  40. Part 2: AUC(TAU) of BMS-986419

    Time frame: Up to approximately Day 15

  41. Part 2: T-Half of BMS-986419

    Time frame: Up to approximately Day 15

  42. Part 2: AI_Cmax of BMS-986419

    Time frame: Up to approximately Day 15

  43. Part 2: AI_AUC(TAU) of BMS-986419

    Time frame: Up to approximately Day 15

  44. Part 2: Trough Concentration of BMS-986419

    Time frame: Up to approximately Day 15

07

Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
08

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06846866
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Feb 26, 2025
Start date
Feb 27, 2025
Primary completion
Oct 21, 2025
Completion
Oct 21, 2025
Last update
Nov 17, 2025

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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