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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289234
• Other study ID #: MCI-186-J23
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2016
• Est. completion date: July 24, 2018

Study information

• Verified date: April 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 24, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• MCI-186
30 mg of edaravone will be administered intravenously over 60 minutes

Locations

Country	Name	City	State
Japan	Investigational site	Fukuoka
Japan	Investigational site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Primary	AUC0-last		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Primary	AUC0-8		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Secondary	t½		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose