A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.

Official Title
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A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of BMS-986165 Tablet Formulation Relative To BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal And Increased Gastric pH on the Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects

Conditions
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Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis, Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: BMS-986165 Capsule
* Drug: BMS-986165 Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be willing and able to complete all study-specific procedures and visits Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening Normal renal function at screening Exclusion Criteria: Women of childbearing potential not using an effective contraceptive method or are breastfeeding Any significant acute or chronic medical illness History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months History of headaches related to caffeine withdrawal, including energy drinks History of syncope, orthostatic instability, or recurrent dizziness Active TB requiring treatment or documented latent TB within the previous 3 years Other protocol defined inclusion/exclusion criteria could apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Tablet-Capsule Crossover 1<br>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations | Drug: BMS-986165 Capsule<br>* Oral capsule<br>Drug: BMS-986165 Tablet<br>* Oral tablet<br>|
| Experimental: Tablet-Capsule Crossover 2<br>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations | Drug: BMS-986165 Capsule<br>* Oral capsule<br>Drug: BMS-986165 Tablet<br>* Oral tablet<br>|
| Experimental: Tablet-Capsule Crossover 3<br>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations | Drug: BMS-986165 Capsule<br>* Oral capsule<br>Drug: BMS-986165 Tablet<br>* Oral tablet<br>|
| Experimental: Tablet-Capsule Crossover 4<br>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations | Drug: BMS-986165 Capsule<br>* Oral capsule<br>Drug: BMS-986165 Tablet<br>* Oral tablet<br>|
| Experimental: Tablet-Capsule Crossover 5<br>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations | Drug: BMS-986165 Capsule<br>* Oral capsule<br>Drug: BMS-986165 Tablet<br>* Oral tablet<br>|
| Experimental: Tablet-Capsule Crossover 6<br>Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations | Drug: BMS-986165 Capsule<br>* Oral capsule<br>Drug: BMS-986165 Tablet<br>* Oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time |  | 5 days | 
| AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time |  | 5 days | 
| Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time |  | 5 days | 
| Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events measured by incidence |  | 26 days | 
| Serious adverse events measured by incidence |  | Approximately 55 days |