An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.

Study Overview
=================
Brief Summary
-----------------
Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine

Official Title
-----------------
An Open-Label, Single Sequence, Crossover Study to Investigate the Effects of OCT1 Inhibition Utilizing Pyrimethamine on Pharmacokinetics of BMS-986165 in Healthy Male Volunteers.

Conditions
-----------------
Healthy Male Volunteers

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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 Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening Additional criteria may 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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS- 986185 + Pyrimethamine<br> | Drug: Pyrimethamine<br>* Oral administration of Pyrimethamine in combination with BMS-986185<br>|
| Experimental: BMS-986185<br> | Drug: BMS-986165<br>* Oral administration of tablet BMS- 986165<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum comcentration (Cmax) |  | Day 1, Day 5 | 
| Area under the concentration-time curve from time zero extrapolated to AUC(INF) |  | Day 1, Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Adverse Events (AE's) |  | Approximetly 20 days | 
| Time of maximum observed concentration (Tmax) |  | Approxmiately 20 days | 
| Half- life time (T-Half) |  | Day 1, Day 5 | 
| Apparent oral clearance (CL/F) |  | Day 5 | 
| Apparent volume of distribution at terminal phase (Vz/F) |  | Day 5 | 
| Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T) |  | Day 5 | 
| Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF) |  | Day 5 |