A Study to Evaluate the Drug Exposure of Single Ascending Doses of BMS-986369 and the Effect of Food on the BMS-986369 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult participants.

Official Title
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A Phase 1, Two-part Study to Evaluate the Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of BMS-986369 and to Explore the Effect of Food the Bioavailability of BMS-986369 in Healthy Participants

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: BMS-986369


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants Must have a normal or clinically-acceptable 12-lead ECG at screening Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1 Exclusion Criteria: Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases History of major surgery within 8 weeks before the first dose administration Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986369, Part 1 dose escalation<br> | Drug: BMS-986369<br>* Specified dose on specified days<br>|
| Experimental: BMS-986369 under fasted conditions, Part 2 Food effect<br> | Drug: BMS-986369<br>* Specified dose on specified days<br>|
| Experimental: BMS-986369 under fed conditions, Part 2 Food effect<br> | Drug: BMS-986369<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Day 1 | 
| Time of maximum observed plasma concentration (Tmax) |  | Day 1 | 
| Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF)) |  | Up to 336 hours after dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) |  | From the date of having consented until 30 days after completion of study treatment | 
| Number of participants with vital sign abnormalities |  | Up to Day 15 | 
| Number of participants with clinical laboratory abnormalities |  | Up to Day 15 | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to Day 15 | 
| Effect of BMS-986369 on ECG parameters - Part 1 |  | Up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986369, Healthy Volunteer, CC-99282