BMS-986278 effect on heart electrical recovery (QT) in healthy adults
A Phase 1, 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 in Healthy Participants
This will test whether BMS-986278 changes the heart's electrical recovery (QT interval) in healthy adults aged 18–55, using placebo and moxifloxacin as comparisons.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT07422298 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial enrolls healthy adult volunteers to measure the effect of BMS-986278 on cardiac repolarization (QT interval) under controlled conditions. Participants receive BMS-986278, placebo, and moxifloxacin (a positive control) to compare ECG effects and confirm assay sensitivity. Careful ECG monitoring, vital signs, and laboratory tests are used to detect any drug-related changes in cardiac electrical activity. The trial is designed to characterize safety signals relevant to QT prolongation before further clinical development.
Who should consider this trial
Good fit: Healthy males and females not of childbearing potential aged 18–55 with BMI 18.0–32.0 kg/m2 who pass medical screening are the intended participants.
Not a fit: People with existing cardiac disease, those who are pregnant or of childbearing potential, or patients seeking therapeutic benefit are unlikely to get direct benefit from this safety study.
Why it matters
Potential benefit: If results show no clinically meaningful QT changes, the drug could safely advance to later trials, supporting its continued development.
How similar studies have performed: QT/prolongation studies using placebo and moxifloxacin as a positive control are a standard, validated approach and have reliably detected cardiac repolarization effects for many drugs.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Female individuals not of childbearing potential and males. * Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments. * 18 to 55 years of age, inclusive, at the time of signing the informed consent with a BMI 18.0 to 32.0 kg/m2, inclusive. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
San Antonio, Texas
- Worldwide Clinical Trials — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.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.