Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment

Study Overview
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Brief Summary
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To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function

Official Title
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A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Conditions
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Hepatic Impairment, Healthy

Intervention / Treatment
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* Drug: MCI-186


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects Able to provide written informed consent to participate in this study after reading the ICF Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements. A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2 Hepatic impaired subjects (in addition) A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment Chronic and stable hepatic impairment Healthy subjects (in addition) Subject with normal hepatic function Good health and free from clinically significant illness or disease Exclusion Criteria: All subjects Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance Subjects were previously administered MCI-186. Positive urine drug screen (if not due to concomitant medication) or alcohol test History of drug abuse Presence of alcohol abuse Presence of active infection requiring antibiotics Positive test for human immunodeficiency virus (HIV) antigen/antibody Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg eGFR <60 mL/min/1.73m2 Hepatic impairment subject (in addition) Subjects with severe ascites Healthy subject (in addition) History or presence of any parenchymal hepatic disease Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mild hepatic impairment<br> | Drug: MCI-186<br>* 30 mg of edaravone will be administered intravenously over 60 minutes<br>* Other names: Radicut;|
| Experimental: moderate hepatic impairment<br> | Drug: MCI-186<br>* 30 mg of edaravone will be administered intravenously over 60 minutes<br>* Other names: Radicut;|
| Experimental: normal hepatic function<br> | Drug: MCI-186<br>* 30 mg of edaravone will be administered intravenously over 60 minutes<br>* Other names: Radicut;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose | 
| AUC0-last |  | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose | 
| AUC0-∞ |  | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| t½ |  | pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose |