A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants

Study Overview
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Brief Summary
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A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.

Detailed Description
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Recruitment temporarily on hold due to COVID-19. This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.

Official Title
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A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986322 in Healthy Participants Including an Open-label Assessment of Food and pH Effects on Relative Bioavailability of BMS-986322

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986322
* Other: BMS-986322 Placebo
* Drug: famotidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Body mass index (BMI) of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening Women and men must agree to follow methods of contraception. Exclusion Criteria: Any significant acute or chronic medical illness History of recent infection History of allergy to BMS-986322 or other compounds Other protocol-defined inclusion/exclusion criteria could apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: BMS-986322<br> | Drug: BMS-986322<br>* Specified Dose on Specified Days<br>Other: BMS-986322 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part B: BMS-986322 Placebo<br> | Drug: BMS-986322<br>* Specified Dose on Specified Days<br>Other: BMS-986322 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: Part C: BMS-986322 with famotidine<br> | Drug: BMS-986322<br>* Specified Dose on Specified Days<br>Drug: famotidine<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 |
| --- | --- | --- |
| Incidence of Death |  | up to 12 months | 
| Incidence of Adverse Effects (AEs) |  | up to 12 months | 
| Incidence of Adverse Events leading to discontinuation |  | up to 12 months | 
| Incidence of Serious Adverse Events (SAEs) |  | up to 12 months | 
| Vital signs of body temperature |  | up to 12 months | 
| Vital signs of blood pressure |  | up to 12 months | 
| Vital signs of respiratory rate |  | up to 12 months | 
| Number of Participants with abnormal physical examinations |  | up to 12 months | 
| Number of clinically significant changes in Electrocardiograms (ECGs) |  | up to 12 months | 
| Number of clinically significant changes in lab assessment of blood serum |  | up to 12 months | 
| Number of clinically significant changes in lab assessment of urine |  | up to 12 months | 
| Number of Clinically significant changes in lab assessment of blood |  | up to 12 months | 
| Maximum concentration (Cmax) of BMS-986322 in Part C |  | up to 12 months | 
| Time of maximum concentration (Tmax) of BMS-986322 in Part C |  | up to 12 months | 
| Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C |  | up to 12 months | 
| Terminal elimination half-life (T-Half) of BMS-986322 in Part C |  | up to 12 months | 
| Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C |  | up to 12 months | 
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C |  | up to 12 months | 
| Apparent oral clearance (CL/F) of BMS-986322 in Part C |  | up to 12 months | 
| Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C |  | up to 12 months |