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Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986533 in Healthy Participants, an Open-label Assessment of Food and pH Effects on the Relative Bioavailability of BMS-986533, and an Open-label Study to Evaluate P-gp- and BCRP-mediated Drug-Drug Interaction Potential of BMS-986533 in Healthy Participants

Who can join

Ages 18 to 55 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Participants must have a body mass index (BMI) of 18 to 32.44 kg/m2, inclusive, and total body weight ≥ 50 kg.
* Female (as assigned at birth) participants who are not of childbearing potential must have documented proof of reproductive status.
* A male (as assigned at birth) who is sexually active with IOCBP must agree to follow instructions for method(s) of contraception as described and included in the ICF.

Exclusion Criteria:

* Participants must not have presence or history of any clinically relevant abnormality, condition, or disease of renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic (including history of angioedema or hypersensitivity reactions to medication).
* Participants must not have current or recent (within 3 months of study intervention administration) clinically significant GI disease.
* Participants must not have any major surgery within 3 months of study intervention administration.
* Participants must not have Any surgical or medical intervention that could possibly affect ADME of study intervention (eg, bariatric surgery, GI surgery).
* Other protocol defined inclusion/exclusion criteria applies.

About the study

The purpose of this study is to evaluate the safety and pharmacokinetics of BMS-986533 in healthy participants receiving single and multiple doses, to assess food and pH effects on the relative bioavailability of BMS-986533, and the P-gp and BCRP-mediated drug-drug interaction potential of the study drug

What is being tested

• BMS-986533 (drug)
• Famotidine (drug)
• Placebo (drug)
• Dabigatran Etexilate (drug)
• Rosuvastatin (drug)

Sponsor: Bristol-Myers Squibb · Participants: 136 · Started: Jul 13, 2026

Contact the study team

• BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286

Official record on ClinicalTrials.gov — NCT07629999

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.