A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.

Official Title
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A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Famotidine
* Drug: Afimetoran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m^2) and 32.0 kg/m^2, inclusive, at screening. A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening. Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula. Exclusion Criteria: Any significant acute or chronic medical illness. Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment. GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.

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: Afimetoran, followed by famotidine + afimetoran<br> | Drug: Famotidine<br>* Specified dose on specified days<br>* Other names: Pepcid;Drug: Afimetoran<br>* Specified dose on specified days<br>* Other names: BMS-986256;|
| Experimental: Famotidine + afimetoran, followed by afimetoran<br> | Drug: Famotidine<br>* Specified dose on specified days<br>* Other names: Pepcid;Drug: Afimetoran<br>* Specified dose on specified days<br>* Other names: BMS-986256;|
| Experimental: Afimetoran<br> | Drug: Afimetoran<br>* Specified dose on specified days<br>* Other names: BMS-986256;|
| Experimental: Famotidine, followed by afimetoran<br> | Drug: Famotidine<br>* Specified dose on specified days<br>* Other names: Pepcid;Drug: Afimetoran<br>* Specified dose on specified days<br>* Other names: BMS-986256;|

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 20 Days | 
| Time to attain maximum observed plasma concentration (Tmax) |  | Up to 20 Days | 
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) |  | Up to 20 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 52 Days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 52 Days | 
| Number of participants with vital sign abnormalities |  | Up to 52 Days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 52 Days | 

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