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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06846866

Run by

Bristol-Myers Squibb

People needed

74

Starts

2025-02-27

Expected to finish

2025-10-21

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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