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

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

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

Conditions
-----------------
Renal Impairment, Healthy

Intervention / Treatment
-----------------
* Drug: MCI-186


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Renal impaired subjects (in addition) Subjects with mild renal impairment defined as eGFR 60-89 mL/min/1.73m2 and subjects with moderate renal impairment defined as eGFR 30-59 mL/min/1.73m2 Chronic and stable renal impairment Healthy subjects (in addition) Subject with normal renal function defined as eGFR≥90 mL/min/1.73m2 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 alcohol abuse or drug abuse Presence of active infection requiring antibiotics Positive test for human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb) Renal impairment subject (in addition) Acute renal failure History of renal transplantation Aspartate aminotransferase (AST) activity, or an alanine aminotransferase (ALT) activity of at least 3 times the upper limit of normal (ULN) range Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>180 mmHg and/or diastolic blood pressure (DBP)>110 mmHg Start of any new medication or new any changes to a current dosage Healthy subject (in addition) History or presence of any renal disease Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: mild renal impairment<br> | Drug: MCI-186<br>* 30 mg of edaravone will be administered intravenously over 60 minutes.<br>* Other names: Radicut;|
| Experimental: moderated renal impairment<br> | Drug: MCI-186<br>* 30 mg of edaravone will be administered intravenously over 60 minutes.<br>* Other names: Radicut;|
| Experimental: normal renal 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?
-----------------
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 |