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

Last updated: March 27, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

BMS-986419

Moxifloxacin Matching Placebo

BMS-986419 Matching Placebo

Clinical Study ID

NCT06846866
CN007-1005
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 74
Treatment Group(s): 4
Primary Treatment: BMS-986419
Phase: 1
Study Start date:
February 27, 2025
Estimated Completion Date:
June 19, 2025

Connect with a study center

  • Celerion

    Tempe, Arizona 85283
    United States

    Active - Recruiting

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