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

Phase 1 Completed 22 enrolled Shionogi

Non-randomizedParallel-groupOpen-labelOther

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

Timeline

Start: 2016-11-16
Primary completion: 2018-07-20
Completion: 2018-07-24

Publications

Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Edaravone	Unknown	30 mg	Intravenous

Indications

No indication recorded.