Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy Males

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate sites of gut absorption of BMS-986165 in males

Official Title
-----------------
Assessment of Regional Gastrointestinal Absorption of BMS-986165 Using Pharmacoscintigraphic Evaluation in Healthy Male Subjects

Conditions
-----------------
Psoriasis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening Estimated glomerular filtration rate (eGFR) > 80 mL/min/1.732 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) disease of the gut that, in the opinion of the Investigator or Medical Monitor, could impact upon the absorption of study drug Acute diarrhea, or constipation within 3 weeks prior to randomization Any major surgery within 4 weeks of randomization Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Formulation B<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Formulation C<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Formulation D<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Formulation E<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Formulation F<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Formulation G<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|
| Experimental: Formulation H<br>Dosage formulation and area of release varies between arms | Drug: BMS-986165<br>* Oral administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D |  | Determined over 5 days | 
| Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D |  | Determined over 5 days | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D |  | Determined over 5 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D |  | Determined over 5 days | 
| Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D |  | Determined over 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs of body temperature |  | Up to 60 days | 
| Pulse rate |  | Up to 60 days | 
| Physical examination |  | Up to 60 days | 
| Incidence of adverse events (AE) |  | Up to 90 days | 
| Incidence of serious adverse events (SAE) |  | Up to 90 days | 
| Vital sign of respiratory rate |  | Up to 60 days | 
| Vital sign of supine blood pressure |  | Up to 60 days |