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

NCT07629999 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CN016-0001
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy; BMS-986533; Food effect; pH effect; rBA; DDI; Dabigatran; Rosuvastatin; Fasted; Fed; Single ascending dose; Multiple ascending dose

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (28)

• 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))

  Up to Day 26 from last dose

• AUC from Time Zero Extrapolated to Infinite Time (AUC(INF))

  Up to Day 26 from last dose

• AUC from Time Zero to 24 Hours (AUC(0-24))

  Up to Day 9 from last dose

Study Arms (4)

Arm A

EXPERIMENTAL

Drug: BMS-986533; Drug: Placebo

Arm B

EXPERIMENTAL

Drug: BMS-986533; Drug: Placebo

Arm C

EXPERIMENTAL

Drug: BMS-986533; Drug: Famotidine

Arm D

EXPERIMENTAL

Drug: BMS-986533; Drug: Dabigatran Etexilate; Drug: Rosuvastatin

Interventions

BMS-986533 DRUG

Specified dose on specified days

Arm A; Arm B; Arm C; Arm D

Famotidine DRUG

Specified dose on specified days

Arm C

Placebo DRUG

Specified dose on specified days

Arm A; Arm B

Dabigatran Etexilate DRUG

Specified dose on specified days

Arm D

Rosuvastatin DRUG

Specified dose on specified days

Arm D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Lincoln, Nebraska, 68502, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Famotidine; Dabigatran; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Pyrimidines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)