Single-dose pharmacokinetics of ibrutinib in subjects with varying degrees of hepatic impairment

• Published in: Leukemia & lymphoma Vol. 58; no. 1; pp. 185 - 194
• Main Authors: de Jong, Jan, Skee, Donna, Hellemans, Peter, Jiao, James, de Vries, Ronald, Swerts, Dominique, Lawitz, Eric, Marbury, Thomas, Smith, William, Sukbuntherng, Juthamas, Mannaert, Erik
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 02.01.2017
• Subjects: Adult; Aged; Area Under Curve; Biomarkers; Drug Monitoring; Female; Hepatic impairment; Humans; ibrutinib; Incidence; Liver Diseases - blood; Liver Diseases - complications; Liver Diseases - diagnosis; Liver Diseases - epidemiology; Liver Function Tests; Male; Middle Aged; Neoplasms - blood; Neoplasms - complications; Neoplasms - drug therapy; pharmacokinetic; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - pharmacokinetics; Pyrazoles - administration & dosage; Pyrazoles - adverse effects; Pyrazoles - pharmacokinetics; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Pyrimidines - pharmacokinetics; safety; Severity of Illness Index; ibrutinib; Hepatic impairment; pharmacokinetic; safety

This open-label, single-dose study was designed to characterize pharmacokinetics and safety profile of ibrutinib in hepatically impaired subjects. Each subject received single oral dose of ibrutinib (140 mg) following an overnight fast (hepatic impairment-mild [n = 6], moderate [n = 10], and severe...