Investigating the safety and effects of BMS-986419 in healthy volunteers
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
This study is testing a new drug called BMS-986419 in healthy volunteers to see if it's safe and how it affects heart function.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06846866 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, tolerability, and pharmacokinetics of BMS-986419 in healthy participants. It consists of two parts: the first part focuses on assessing the safety and drug levels of BMS-986419, while the second part examines the effects of multiple doses on cardiac repolarization. Participants will receive either the active drug or a matching placebo, and their health will be monitored through various assessments. The study is designed to ensure that participants meet specific health criteria to minimize risks.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults with a BMI between 18.0 and 30.0 kg/m².
Not a fit: Patients with significant acute or chronic medical illnesses or a history of clinically relevant cardiac disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of BMS-986419, potentially leading to new treatment options.
How similar studies have performed: Other studies investigating similar pharmacokinetic profiles and cardiac effects have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tempe, Arizona
- Celerion — Tempe, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.