Recruiting

Phase 1

BMS-986533Single 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

Sponsor:

Bristol-Myers Squibb

Code:

NCT07629999

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

BMS-986533

Famotidine

Placebo

Dabigatran Etexilate

Rosuvastatin

Study Details

Brief 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

Conditions

Healthy Volunteers

Study ID

NCT07629999

Start date

Jul 13, 2026

Status verified date

Jul, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

experimental: Arm B

experimental: Arm C

experimental: Arm D

Interventions

BMS-986533