A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment

Study Overview
=================
Brief Summary
-----------------
An oral dose of BMS-986177 administered in End-stage Renal Dysfunction (ESRD) participants before and after a hemodialysis session to evaluate safety, tolerability, and pharmacokinetics in this patient population.

Official Title
-----------------
An Open-label Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment

Conditions
-----------------
Thrombosis, Factor XI, Renal Impairment, ESRD (End-Stage Renal Disease)

Intervention / Treatment
-----------------
* Drug: BMS-986177


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Classified at screening as having ESRD requiring hemodialysis at least 3 times per week for 3 months. Clinical, ECG, and laboratory findings consistent with renal dysfunction BMI of 18.0 to 38.0 kg/m2 inclusive Subjects must receive unfractionated heparin during dialysis treatments and are able to withstand a decrease in their established heparin dose (75% of current dose) Women Not of child bearing potential (WNOCBP). Sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control Exclusion Criteria: History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening Evidence or history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery that could interfere with absorption of study drug Any condition requiring anticoagulation such as, but not limited to, atrial fibrillation, mechanical prosthetic valve, deep venous thrombosis, or pulmonary embolism (other than heparin required during hemodialysis) Need for aspirin or need for P2Y12 antagonist therapy (for example clopidogrel, prasugrel, or ticagrelor) Other protocol defined exclusion criteria could apply

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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: End Stage Renal Disease Subjects<br>Subjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session | Drug: BMS-986177<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the Number of subjects with Adverse events (AEs). |  | Day -1 - day 3 | 
| To assess the Change from baseline in Physical examination parameters. |  | Day -1 - day 3 | 
| To assess the change from baseline in Electrocardiogram (ECG) assessment. |  | Day -1 - day 3 | 
| To assess the change from baseline in clinical laboratory values. |  | Day -1 - day 3 | 
| To assess the change from baseline in vital signs assessment. |  | Day -1 - day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change from baseline in activated partial thromboplastin time (aPTT). |  | Day -1 - day 3 | 
| To assess the change from baseline in Factor XI clotting activity (FX1c ). |  | Day -1 - day 3 |