Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

Study Overview
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Brief Summary
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A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects

Official Title
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Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: BMS-986177


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women not of childbearing potential (WNOCBP) and males. Women must have documented proof they are not of childbearing potential BMI of 20.0 to 38.0 kg/m2, inclusive Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values Exclusion Criteria: Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug Other protocol defined inclusion and exclusion criteria may apply

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild Hepatic Subjects<br>Subjects are given a single dose of BMS-986177 | Drug: BMS-986177<br>* Single oral dose<br>|
| Experimental: Moderate Hepatic Subjects<br>Subjects are given a single dose of BMS-986177 | Drug: BMS-986177<br>* Single oral dose<br>|
| Experimental: Healthy Match Subjects<br>Subjects are given a single dose of BMS-986177 | Drug: BMS-986177<br>* Single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-986177 |  | Up to 5 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177 |  | Up to 5 days | 
| Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177 |  | Up to 5 days | 
| Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177 |  | Up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation |  | Screening until 30 days after discontinuation of dosing or subject's participation | 
| Number of participants with clinical laboratory abnormalities |  | Screening until 30 days after discontinuation of dosing or subject's participation | 
| Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG) |  | Screening until 30 days after discontinuation of dosing or subject's participation | 
| Number of participants with vital sign abnormalities |  | Screening until 30 days after discontinuation of dosing or subject's participation |