A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

Recruiting at 1 trial location

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Chronic illness, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves assessing the effect of a new drug on other substances, it's possible that some medications might need to be paused. Please consult with the trial coordinators for specific guidance.

What is the purpose of this trial?

This trial tests a new drug, BMS-986419, to see how it affects the body's handling of other common medications in healthy people.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.

Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1)

Exclusion Criteria

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

Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention

Other protocol-defined inclusion/exclusion criteria apply.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single doses of probe substrates and BMS-986419 to assess pharmacokinetics

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986419

Participant Groups

Group I: Cocktail Probe Substrates + BMS-986419 Experimental Treatment 7 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