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

• Status: Completed
• Trial end date: 2018-07-24
• 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 Hepatic impairment compared to subjects with normal hepatic 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

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)