An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.

Official Title
-----------------
An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects

Conditions
-----------------
Healthy Participants

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


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2 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 Positive anti- John Cunningham virus (JCV) antibody test at Screening History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy 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 + MMF<br>Oral administration | Drug: BMS-986165<br>* Specified dose on specified days<br>Drug: MMF<br>* Specified dose on specified days<br>* Other names: Mycophenolate Mofetil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of mycophenolic acid (MPA) |  | 18 days | 
| Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA |  | 18 days | 
| AUC extrapolated to infinity (AUC[INF]) of MPA |  | 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AE) |  | Up to 48 days | 
| Number of serious adverse events (SAE) |  | Up to 48 days | 
| Number of AEs leading to discontinuation |  | Up to 48 days | 
| Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results |  | 18 days |