NCT07629999PHASE1RecruitingAccepts Healthy Volunteers
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
Bristol-Myers Squibb
Start Date
7/13/2026
Completion Date
6/1/2027
Summary
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
Eligibility Criteria
Age Range: 18 years to 55 years
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.
Interventions
DRUG
BMS-986533
DRUG
Famotidine
DRUG
Placebo
DRUG
Dabigatran Etexilate
DRUG
Rosuvastatin
Conditions
Healthy Volunteers
Locations
Celerion Coorporate Office Nebraska
Lincoln, Nebraska 68502
United States