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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: Rosuvastatin; Drug: Famotidine; Drug: BMS-986533; Drug: Dabigatran Etexilate

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Recruiting
      • Celerion Coorporate Office Nebraska
      • Contact: Allen Hunt, Site 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A	Drug: Placebo; Specified dose on specified days; Drug: BMS-986533; Specified dose on specified days
Experimental: Arm B	Drug: Placebo; Specified dose on specified days; Drug: BMS-986533; Specified dose on specified days
Experimental: Arm C	Drug: Famotidine; Specified dose on specified days; Drug: BMS-986533; Specified dose on specified days
Experimental: Arm D	Drug: Rosuvastatin; Specified dose on specified days; Drug: BMS-986533; Specified dose on specified days; Drug: Dabigatran Etexilate; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events (AE)		Up to Day 47
Number of participants with Serious Adverse Events (SAE)		Up to Day 47
Number of participants with Vital Sign Abnormalities		Up to Day 27
Number of participants with Physical Examination Abnormalities	Including neurological examination	Up to Day 27
Number of participants with Electrocardiogram (ECG) Abnormalities		Up to Day 27
Number of participants with Clinical Laboratory Assessments Abnormalities		Up to Day 27
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)		Up to Day 27

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed concentration (Cmax)		Up to Day 26 from last dose
Time of maximum observed concentration (Tmax)		Up to Day 26 from last dose
Area under the concentration-time curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))	Arm A, Arm B, and Arm C	Up to Day 26 from last dose
AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))	Arm A and Arm C	Up to Day 26 from last dose
AUC from Time Zero to 24 Hours (AUC(0-24))	Arm A	Up to Day 9 from last dose
Elimination Half-Life (T-HALF)	Arm A, Arm B, and Arm C	Up to Day 26 from last dose
Apparent Total Body Clearance from Plasma (CLT/F)	Arm A, Arm B, and Arm C	Up to Day 26 from last dose
Apparent Volume of Distribution (Vz/F)	Arm A, Arm B, and Arm C	Up to Day 26 from last dose
AUC in 1 dosing interval (AUC (TAU))	Arm B, D	Up to Day 22 from last dose
Cerebrospinal fluid (CSF) concentrations	Arm B	Up to Day 13
Ratio of total and unbound CSF to plasma concentration	Arm B	Up to Day 13
Geometric mean ratio of Cmax	Arm C, D	Up to Day 26 from last dose
Geometric mean ratio of AUC(0-T)	Arm C, D	Up to Day 26 from last dose
Geometric mean ratio of AUC(INF)	Arm C, D	Up to Day 26 from last dose
Cmax of dabigatran in plasma	Arm D	Up to Day 18 from last dose
Cmax of rosuvastatin in plasma	Arm D	Up to Day 20 from last dose
AUC(0-T) of dabigatran in plasma	Arm D	Up to Day 18 from last dose
AUC(0-T) of rosuvastatin in plasma	Arm D	Up to Day 20 from last dose
AUC(INF) of dabigatran in plasma	Arm D	Up to Day 18 from last dose
AUC(INF) of rosuvastatin in plasma	Arm D	Up to Day 20 from last dose
Tmax of dabigatran in plasma	Arm D	Up to Day 18 from last dose
Tmax of rosuvastatin in plasma	Arm D	Up to Day 20 from last dose
T-HALF of dabigatran in plasma		Up to Day 26 from last dose
T-HALF of rosuvastatin in plasma	Arm D	Up to Day 20 from last dose
CLT/F of dabigatran in plasma	Arm D	Up to Day 18 from last dose
CLT/F of rosuvastatin in plasma		Up to Day 27 from last dose
Vz/F of dabigatran in plasma	Arm D	Up to Day 18 from last dose
Vz/F of rosuvastatin in plasma	Arm D	Up to Day 20 from last dose

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Healthy; Food effect; Rosuvastatin; Dabigatran; Multiple ascending dose; Single ascending dose; Fed; DDI; Fasted; BMS-986533; pH effect; rBA
• Additional Relevant MeSH Terms: Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Hypoalphalipoproteinemias; Hypolipoproteinemias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Lecithin Cholesterol Acyltransferase Deficiency; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Azoles; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Dabigatran; Rosuvastatin Calcium; Famotidine
• Other Study ID Numbers: CN016-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No