NCT03289234

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Hepatic Impairment
• Healthy

Interventions

Type	Name	Description
DRUG	MCI-186	30 mg of edaravone will be administered intravenously over 60 minutes

Timeline

• Start date: 2016-11-16
• Primary completion: 2018-07-20
• Completion: 2018-07-24
• First posted: 2017-09-20
• Last updated: 2026-01-08
• Results posted: 2020-02-28

Locations

2 sites across 1 country: Japan