A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.

Official Title
-----------------
An Open-Label, Single-Sequence Study to Investigate the Effects of BMS-986165 on the Single-Dose Pharmacokinetics of Methotrexate in Healthy Male Subjects

Conditions
-----------------
Lupus, Psoriatic Arthritis

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: Leucovorin
* 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 (BMI): 18.0 - 32.0 kg/m2 Normal renal function at screening Exclusion Criteria: Any medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease Any contraindication indicated in the MTX package insert History or presence of chronic bacterial or viral infection History or presence of an autoimmune disorder Any significant acute or chronic medical illness Active TB requiring treatment or documented latent TB within the previous 3 years Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165+Methotrexate+Leucovorin<br>Three treatments administered | Drug: Methotrexate<br>* Specified dose on specified days<br>* Other names: MTX;Drug: Leucovorin<br>* Specified dose on specified days<br>* Other names: LEU;Drug: BMS-986165<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Approximately 14 days | 
| Time to attain maximum observed plasma concentration (Tmax) |  | Approximately 14 days | 
| Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)] |  | Approximately 14 days | 
| Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)] |  | Approximately 14 days | 
| Terminal elimination rate constant (kel) |  | Approximately 14 days | 
| Terminal elimination half life, calculated as 0.693/kel (T-HALF) |  | Approximately 14 days | 
| Apparent oral clearance (CL/F) |  | Approximately 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Approximately 19 days | 
| Incidence of serious adverse events (SAEs) |  | Approximately 19 days |