Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment

Study Overview
=================
Brief Summary
-----------------
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.

Official Title
-----------------
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment

Conditions
-----------------
Thrombosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1 Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive Females must be of non-childbearing potential Exclusion Criteria: Participants in Groups B and C cannot have an indwelling catheter for hemodialysis Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant Other protocol defined inclusion and exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Normal Renal Function | Drug: BMS-986177<br>* Oral Suspension<br>|
| Experimental: Group B<br>Moderate Renal Impairment | Drug: BMS-986177<br>* Oral Suspension<br>|
| Experimental: Group C<br>Severe Renal Impairment | Drug: BMS-986177<br>* Oral Suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) | Measured by plasma concentration | Up to 5 days | 
| AUC from time zero to time of last quantifiable concentration (AUC (0-T)) | Summary measures of PK parameters | Up to 5 days | 
| AUC from time zero extrapolated to infinite time (AUC (INF)) | Summary measures of PK parameters | Up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | Safety and tolerability as measured by incidence of AEs | Up to 5 days | 
| Incidence of Serious Adverse Events ( SAEs) | Safety and tolerability as measured by incidence of SAEs | Up to 30 days | 
| Change from baseline in electrocardiogram findings | Measured by investigator assessment | Up to 5 days | 
| Change from baseline in physical examination findings | Measured by investigator assessment | Up to 5 days | 
| Change from baseline in clinical laboratory test findings | Measured by investigator assessment | Up to 5 days |