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

Phase 1Not Yet RecruitingNCT07629999

Bristol-Myers Squibb118 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

118

Conditions

Healthy Volunteers

Interventions

BMS-986533DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of participants with Adverse Events (AE)

Time frame: Up to Day 47

Number of participants with Serious Adverse Events (SAE)

Time frame: Up to Day 47

Number of participants with Vital Sign Abnormalities

Time frame: Up to Day 27

Number of participants with Physical Examination Abnormalities

Including neurological examination

Time frame: Up to Day 27

Number of participants with Electrocardiogram (ECG) Abnormalities

Time frame: Up to Day 27

Number of participants with Clinical Laboratory Assessments Abnormalities

Time frame: 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)

Time frame: Up to Day 27

Secondary Outcomes

Maximum observed concentration (Cmax)

Time frame: Up to Day 26 from last dose

Time of maximum observed concentration (Tmax)

Time frame: 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

Time frame: Up to Day 26 from last dose

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

Arm A and Arm C

Time frame: Up to Day 26 from last dose

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

Arm A

Time frame: Up to Day 9 from last dose

Elimination Half-Life (T-HALF)

Arm A, Arm B, and Arm C

Time frame: Up to Day 26 from last dose

Apparent Total Body Clearance from Plasma (CLT/F)

Arm A, Arm B, and Arm C

Time frame: Up to Day 26 from last dose

Apparent Volume of Distribution (Vz/F)

Arm A, Arm B, and Arm C

Time frame: Up to Day 26 from last dose

AUC in 1 dosing interval (AUC (TAU))

Arm B, D

Time frame: Up to Day 22 from last dose

Cerebrospinal fluid (CSF) concentrations

Arm B

Time frame: Up to Day 13

Ratio of total and unbound CSF to plasma concentration

Arm B

Time frame: Up to Day 13

Geometric mean ratio of Cmax

Arm C, D

Time frame: Up to Day 26 from last dose

Geometric mean ratio of AUC(0-T)

Arm C, D

Time frame: Up to Day 26 from last dose

Geometric mean ratio of AUC(INF)

Arm C, D

Time frame: Up to Day 26 from last dose

Cmax of dabigatran in plasma

Arm D

Time frame: Up to Day 18 from last dose

Cmax of rosuvastatin in plasma

Arm D

Time frame: Up to Day 20 from last dose

AUC(0-T) of dabigatran in plasma

Arm D

Time frame: Up to Day 18 from last dose

AUC(0-T) of rosuvastatin in plasma

Arm D

Time frame: Up to Day 20 from last dose

AUC(INF) of dabigatran in plasma

Arm D

Time frame: Up to Day 18 from last dose

AUC(INF) of rosuvastatin in plasma

Arm D

Time frame: Up to Day 20 from last dose

Tmax of dabigatran in plasma

Arm D

Time frame: Up to Day 18 from last dose

Tmax of rosuvastatin in plasma

Arm D

Time frame: Up to Day 20 from last dose

T-HALF of dabigatran in plasma

Time frame: Up to Day 26 from last dose

T-HALF of rosuvastatin in plasma

Arm D

Time frame: Up to Day 20 from last dose

CLT/F of dabigatran in plasma

Arm D

Time frame: Up to Day 18 from last dose

CLT/F of rosuvastatin in plasma

Time frame: Up to Day 27 from last dose

Vz/F of dabigatran in plasma

Arm D

Time frame: Up to Day 18 from last dose

Vz/F of rosuvastatin in plasma

Arm D

Time frame: Up to Day 20 from last dose

Central 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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts