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OpenTrials
Completed

NCT Number: NCT06846866

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

BMS-986419

Drug

Specified dose on specified days

BMS-986419 Matching Placebo

Drug

Specified dose on specified days

moxifloxacin

Drug

Specified dose on specified days

Moxifloxacin Matching Placebo

Drug

Specified dose on specified days

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

    Time frame: Up to approximately Day 21

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

  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)

    Time frame: Up to approximately Day 15

    ΔQTc is performed by primary correction.

  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

    Time frame: Up to approximately Day 15

    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.

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

    Time frame: Up to approximately Day 15

    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.

  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

    Time frame: Up to approximately Day 15

    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.

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

    Time frame: Up to approximately Day 15

    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.

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

    Time frame: Up to approximately Day 15

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

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

    Time frame: Up to approximately Day 15

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

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

    Time frame: Up to approximately Day 15

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

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

    Time frame: Up to approximately Day 15

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

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

    Time frame: Up to approximately Day 15

    "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).

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

    Time frame: Up to approximately Day 15

    ΔQTc is performed by primary correction.

  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

    Time frame: Up to approximately Day 15

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

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986419 (Part 1) and a Phase 1 Randomized, Double-blind, Positive-controlled, Placebo-controlled, Parallel, Nested-crossover (Moxifloxacin-placebo) Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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