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

• Status: Completed
• Trial end date: 2018-04-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Edaravone; Phenylmethylpyrazolone

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