Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of gastric pH changes due to famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in healthy participants.

Official Title
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A Phase 1, Open-label, Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of BMS-986256 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986256
* Drug: Famotidine


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy participants having no clinically significant deviations from normal in medical history, physical examination (PE) findings, electrocardiograms (ECGs), vital signs, and clinical laboratory results that would compromise the ability to participate, complete, and/or interpret the results of the study Weight ≥ 50 kg and body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 inclusive at screening Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial Exclusion Criteria: Women who are pregnant or breastfeeding Any significant acute or chronic medical illness Any major surgery within 4 weeks of study treatment administration Any other sound medical, psychiatric, and/or social reason as determined by the investigator 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986256<br> | Drug: BMS-986256<br>* Specified dose on specified days<br>|
| Experimental: BMS-986256 + Famotidine<br> | Drug: BMS-986256<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 |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 39 days | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T) |  | Up to 39 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) |  | Up to 39 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 47 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 74 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 67 days | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to 67 days | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to 67 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 74 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 74 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 74 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 74 days | 
| Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters |  | Up to 74 days |