A Study to Determine the Effect of 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 induced by famotidine on the drug levels of BMS-986256.

Official Title
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A Phase 1 Open-label, 2-Period 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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Inclusion Criteria: Healthy participants, defined as having no clinically significant deviations from normal in medical history Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening Normal renal function at screening Exclusion Criteria: Any significant acute or chronic medical illness Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment Any major surgery within 4 weeks of study treatment administration Significant history of GI abnormalities 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence AB<br> | Drug: BMS-986256<br>* Specified dose on specified days<br>Drug: Famotidine<br>* Specified dose on specified days<br>* Other names: Pepcid;|
| Experimental: Sequence BA<br> | Drug: BMS-986256<br>* Specified dose on specified days<br>Drug: Famotidine<br>* Specified dose on specified days<br>* Other names: Pepcid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-986256 |  | Up to 19 days | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256 |  | Up to 19 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256 |  | Up to 19 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 45 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 45 days | 
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests |  | Up to 45 days | 
| Incidence of clinically significant changes in clinical laboratory values: Chemistry tests |  | Up to 45 days | 
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests |  | Up to 45 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 45 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 45 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 45 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 45 days | 
| Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 45 days | 
| Incidence of clinically significant changes in ECG parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 45 days | 
| Incidence of clinically significant changes in ECG parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave | Up to 45 days | 
| Incidence of clinically significant changes in ECG parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 45 days | 
| Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine) |  | Up to 45 days | 
| Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine) |  | Up to 45 days | 
| Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine) |  | Up to 45 days | 
| Time of maximum observed plasma concentration (Tmax) of BMS-986256 |  | Up to 45 days | 
| Apparent terminal plasma half-life (T-HALF) of BMS-986256 |  | Up to 45 days | 
| Apparent total body clearance (CLT/F) of BMS-986256 |  | Up to 45 days | 
| Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256 |  | Up to 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants, BMS-986256, Famotidine, Gastric pH