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

• Published in: Clinical therapeutics Vol. 42; no. 8; pp. 1467 - 1482.e4
• Main Authors: Nakamaru, Yoshinobu, Kakubari, Masae, Yoshida, Kaori, Akimoto, Makoto, Todorovic, Vesna, Greis, Thomas, Kondo, Kazuoki
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2020; Elsevier Limited
• Subjects: Adolescent; Adult; Aged; Amyotrophic lateral sclerosis; Area Under Curve; Birth control; Body mass index; Bradycardia; Bradycardia - chemically induced; Cytochrome; Disease; Dosage; Drug dosages; edaravone; Edaravone - adverse effects; Edaravone - blood; Edaravone - pharmacokinetics; FDA approval; Female; Free Radical Scavengers - adverse effects; Free Radical Scavengers - blood; Free Radical Scavengers - pharmacokinetics; hepatic insufficiency; Humans; Internal Medicine; Liver; Liver Diseases - blood; Liver Diseases - metabolism; Male; Medical Education; Medical laboratories; Metabolites; Middle Aged; mild–moderate; Neuroprotective Agents - adverse effects; Neuroprotective Agents - blood; Neuroprotective Agents - pharmacokinetics; Pharmacokinetics; severe; Sulfates; tolerability; Urine; Vital signs; Young Adult; Japan; hepatic insufficiency; pharmacokinetics; mild–moderate; edaravone; severe; tolerability

Two studies were conducted to assess the pharmacokinetic (PK) properties and tolerability of edaravone in Japanese subjects with mild to moderate hepatic impairment or normal hepatic functioning (study 1), and in white subjects with severe hepatic impairment compared to subjects with normal hepatic...