A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by healthy participants.

Official Title
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A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Reference Treatment- BMS-986165-01
* Drug: Prototype BMS-986165
* Drug: Famotidine
* Other: Alcohol


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: No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb). BMI = weight (kg)/(height [m])2 at screening. Willing and able to consume 4 units of alcohol (Part B only) A negative polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at screening and admission Males and females must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease. Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening. 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: Part A: Reference Treatment<br> | Drug: Reference Treatment- BMS-986165-01<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: Part A Prototype<br> | Drug: Prototype BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: Part C Reference Treatment<br> | Drug: Reference Treatment- BMS-986165-01<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: Part C: Prototype<br> | Drug: Prototype BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: Part B: Treatment 1<br> | Drug: Prototype BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: Part B: Treatment 2<br> | Drug: Prototype BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: Part B: Treatment 3<br> | Drug: Prototype BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|
| Experimental: Part B: Treatment 4<br> | Drug: Prototype BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;Drug: Famotidine<br>* Specified dose on specified days<br>|
| Experimental: Part B: Treatment 5<br> | Drug: Prototype BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;Other: Alcohol<br>* Specified quantity 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) of BMS-986165 |  | Day 1 and Day 7 | 
| Time of maximum observed plasma concentration (Tmax) of BMS-986165 |  | Day 1 and Day 7 | 
| Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165 | Part A, B, C | Day 1 and Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nonserious Adverse Events (AEs) |  | Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B) | 
| Incidence of Serious Adverse Events (AEs) |  | Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B) | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in electrocardiogram (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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| Incidence of clinically significant changes in electrocardiogram (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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 
| 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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers