Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
Condition: Renal Impairment; Healthy
MeSH terms: Renal Insufficiency
Intervention: MCI-186
Intervention description: 30 mg of edaravone will be administered intravenously over 60 minutes.
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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