A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.

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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Deucravacitinib
* 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, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead 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). Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females). 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;|
| Experimental: Part B<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;|
| Experimental: Part C<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;Drug: Famotidine<br>* Specified dose on specified days<br>* Other names: Pepcid;|
| Experimental: Part D<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>* Other names: BMS-986165;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of deucravacitinib |  | Up to 7 days | 
| Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib |  | Up to 7 days | 
| Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib |  | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of non-serious Adverse Events (AEs) |  | Up to 18 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 30 days post discontinuation of dosing or participant's participation in the study | 
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests |  | Up to 11 days | 
| Incidence of clinically significant changes in clinical laboratory values: Chemistry tests |  | Up to 11 days | 
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests |  | Up to 11 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 11 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 11 days | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 11 days | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 11 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 11 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 11 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 11 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 11 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants, Deucravacitinib, BMS-986165