42 Participants Needed

BMS-986278 for Healthy Subjects

Recruiting at 3 trial locations
Fl
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986278
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.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Group I: Part B3 Treatment DExperimental Treatment2 Interventions
Group II: Part B3 Treatment CExperimental Treatment1 Intervention
Group III: Part B3 Treatment BExperimental Treatment2 Interventions
Group IV: Part B3 Treatment AExperimental Treatment1 Intervention
Group V: Part B1/B2 Treatment DExperimental Treatment2 Interventions
Group VI: Part B1/B2 Treatment CExperimental Treatment1 Intervention
Group VII: Part B1/B2 Treatment BExperimental Treatment2 Interventions
Group VIII: Part B1/B2 Treatment AExperimental Treatment1 Intervention
Group IX: Part AExperimental Treatment2 Interventions

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

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