Investigating the safety and effects of BMS-986278 in healthy individuals
A Phase 1, Two-Part, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986278 (Part A) and a Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization (Part B) in Healthy Participants
This study is testing a new drug called BMS-986278 in healthy people to see if it's safe and how it affects heart function compared to a placebo and another medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT06746402 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, tolerability, and pharmacokinetics of BMS-986278 in healthy participants. It will also assess the drug's impact on cardiac repolarization as measured by ECG intervals. Participants will receive either BMS-986278, a placebo, or moxifloxacin to compare effects. The study is designed to ensure that only healthy individuals, as determined by various medical assessments, are included.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult males and females not of childbearing potential with a BMI between 18.0 and 32.0 kg/m2.
Not a fit: Patients with significant acute or chronic medical illnesses or a history of cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and cardiac effects of BMS-986278, potentially leading to its use in treating various conditions.
How similar studies have performed: Other studies investigating similar pharmacokinetic and safety profiles of new drugs have shown success, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female individuals not of childbearing potential (INOCBP) and males. * Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments. * Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B. Exclusion Criteria: * Any significant acute or chronic medical illness as determined by the investigator. * 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. * Any significant history of disease of the cardiovascular system that in the opinion of the Investigator makes the participant unsuitable for enrollment into the study. * Other protocol-defined inclusion/exclusion criteria apply.
Where this trial is running
San Antonio, Texas and 1 other locations
- Local Institution - 0002 — San Antonio, Texas, United States (Not_yet_recruiting)
- ICON Salt Lake City — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 8559073286
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.