BMS-986278 for Healthy Subjects

Recruiting at 2 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Bristol-Myers Squibb

Disqualifiers: Cardiac disease, Arrhythmias, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that you may need to pause certain medications. Please consult with the trial coordinators for specific guidance.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for healthy individuals who can safely receive high doses of a new drug, BMS-986278. Participants should not have any known health conditions that could interfere with the study or pose additional risks.

Inclusion Criteria

I am either a male or a female not able to have children.

I am healthy based on recent medical exams and tests.

Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive, for Parts A and B

Exclusion Criteria

My heart health does not prevent me from joining this study.

Other protocol-defined inclusion/exclusion criteria apply

Any significant acute or chronic medical illness as determined by the investigator

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive high dose of BMS-986278 to assess safety, tolerability, and pharmacokinetics

Up to 18 days

Treatment Part B

Participants undergo a 4-period crossover study to evaluate the effect of BMS-986278 on cardiac repolarization

Up to 68 days (4 periods of 17 days each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days post last treatment dose

Treatment Details

Interventions

• BMS-986278 (Other)

Trial Overview The study tests the safety and tolerability of BMS-986278 in healthy people. It also looks at how the body processes the drug (pharmacokinetics) and its effects on heart electrical activity as measured by ECG intervals.

Participant Groups

Group I: Part B3 Treatment D Experimental Treatment 2 Interventions

Group II: Part B3 Treatment C Experimental Treatment 1 Intervention

Group III: Part B3 Treatment B Experimental Treatment 2 Interventions

Group IV: Part B3 Treatment A Experimental Treatment 1 Intervention

Group V: Part B1/B2 Treatment D Experimental Treatment 2 Interventions

Group VI: Part B1/B2 Treatment C Experimental Treatment 1 Intervention

Group VII: Part B1/B2 Treatment B Experimental Treatment 2 Interventions

Group VIII: Part B1/B2 Treatment A Experimental Treatment 1 Intervention

Group IX: Part A Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania