pci-32765 and Liver-Diseases

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 [n = 8]; healthy control [n = 6]). Subjects with hepatic impairment showed significant increase in ibrutinib plasma exposures and fraction unbound ibrutinib. Compared to control group, mean exposure (AUC

Topics: Adenine; Adult; Aged; Area Under Curve; Biomarkers; Drug Monitoring; Female; Humans; Incidence; Liver Diseases; Liver Function Tests; Male; Middle Aged; Neoplasms; Piperidines; Protein Kinase Inhibitors; Pyrazoles; Pyrimidines; Severity of Illness Index

Ronald de Vries graduated in Organic and Analytical Chemistry at the Free University of Amsterdam, The Netherlands. After working in a Contract Laboratory (CRO) for 7 years, he joined Janssen R&D in 1998. At Janssen R&D, Belgium, Ronald worked in the bioanalytical department that supports both clinical and nonclinical bioanalysis. In this department he had several roles, such as providing the bioanalytical support for various drug development programs and leading the method establishment group. He has done numerous global assay transfers to/from Janssen from/to other laboratories and plays an important role in the introduction and application of new technologies and applied innovation in the department. In 2014 he started in the drug metabolism and pharmacokinetics department of Janssen R&D, where his main tasks are in vivo and in vitro metabolite identification using high resolution MS and Radiodetection.

Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Bile Acids and Salts; Blood Chemical Analysis; Calibration; Chromatography, High Pressure Liquid; Humans; Liver Diseases; Piperidines; Protein-Tyrosine Kinases; Pyrazoles; Pyrimidines; Quality Control; Tandem Mass Spectrometry; Taurocholic Acid