CompletedPhase 1

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants

United States42 participantsStarted 2025-02-10

Plain-language summary

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with non-serious Adverse Events (AEs)

Timeframe: Until 28 days post last treatment dose

Number of participants with Serious AEs (SAEs)

Timeframe: Until 28 days post last treatment dose

Number of participants with AEs leading to study intervention discontinuation

Timeframe: Until 28 days post last treatment dose

Number of participants with vital sign abnormalities

Timeframe: Up to Day 18

Number of participants with clinical laboratory assessment abnormalities

Timeframe: Up to Day 18

Number of participants with 12-lead electrocardiogram (ECG) abnormalities

Timeframe: Up to Day 18

Number of participants with physical examination abnormalities

Timeframe: Up to Day 18

Trial details

NCT IDNCT06746402

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-11

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with non-serious Adverse Events (AEs)

Timeframe: Until 28 days post last treatment dose

Number of participants with Serious AEs (SAEs)

Timeframe: Until 28 days post last treatment dose

Number of participants with AEs leading to study intervention discontinuation

Timeframe: Until 28 days post last treatment dose

Number of participants with vital sign abnormalities

Timeframe: Up to Day 18

Number of participants with clinical laboratory assessment abnormalities

Timeframe: Up to Day 18

Number of participants with 12-lead electrocardiogram (ECG) abnormalities

Timeframe: Up to Day 18

Number of participants with physical examination abnormalities

Timeframe: Up to Day 18