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

Launched by BRISTOL-MYERS SQUIBB · Feb 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called BMS-986419 to understand how safe it is and how it behaves in the body, especially regarding its effects on the heart. The study has two parts: in the first part, researchers will test the safety and how well the body can handle the medication in healthy volunteers. In the second part, they will see how multiple doses of BMS-986419 affect the heart’s electrical activity, which is important for keeping the heart beating normally.

To participate, volunteers need to be healthy adults aged between 18 and 65 years, with a body mass index (BMI) between 18.0 and 30.0. They should not have any serious medical conditions, particularly related to the heart or digestive system, and must not have taken any other investigational drugs recently. Participants in this trial can expect to undergo health assessments and regular monitoring during the study. This is an exciting opportunity to contribute to research that could help develop new treatments, and all involved will be closely supervised by medical professionals throughout the process.

Gender

ALL

Eligibility criteria

• • 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.