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 (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Famotidine; Drug: Rosuvastatin; Drug: BMS-986533; Drug: Placebo; Drug: Dabigatran Etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07629999

CN016-0001

Details and patient eligibility

About

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

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 4 patient groups

Arm A

Experimental group

Treatment:

Drug: Placebo

Drug: BMS-986533

Arm B

Experimental group

Treatment:

Drug: Placebo

Drug: BMS-986533

Arm C

Experimental group

Treatment:

Drug: BMS-986533

Drug: Famotidine

Arm D

Experimental group

Treatment:

Drug: Dabigatran Etexilate

Drug: BMS-986533

Drug: Rosuvastatin