BMS-986322 + Rosuvastatin + Metformin + Methotrexate for Healthy Subjects

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Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, BMS-986322, to see how it works when taken with three other common medications. The study involves healthy participants to ensure clear results. Researchers aim to find out if there are any interactions or side effects when these drugs are taken together.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.

Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)^2 to 30.0 kg/m^2, inclusive, and body weight ≥ 50 kg for males and ≥ 45 kg for females, at screening.

A female participant is eligible to participate if she is a woman not of childbearing potential.

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria apply.

Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration.

You have a serious or ongoing medical condition.

Treatment Details

Interventions

• BMS-986322 (Monoclonal Antibodies)
• Metformin (Antidiabetic Agent)
• Rosuvastatin (Hypolipidemic Agent)

Participant Groups

Group I: Part 3: Methotrexate + BMS-986322 + Leucovorin Experimental Treatment 3 Interventions

Group II: Part 2: Metformin + BMS-986322 + Glucose Experimental Treatment 3 Interventions

Group III: Part 1: Rosuvastatin + BMS-986322 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