A Study to Evaluate the Pharmacokinetics of PCI-32765 in Participants With Varying Degrees of Hepatic Impairment

Phase 1 Completed 30 enrolled Janssen Research & Development, LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of PCI 32765 in participants with mild, moderate, or severe hepatic impairment.

Timeline

Start: 2012-12
Primary completion: 2013-11
Completion: 2013-11

Publications

de Jong J, Skee D, Hellemans P, Jiao J, de Vries R, Swerts D, Lawitz E, Marbury T, Smith W, Sukbuntherng J, Mannaert E. Single-dose pharmacokinetics of ibrutinib in subjects with varying degrees of hepatic impairment<sup/> Leuk Lymphoma. 2017 Jan;58(1):185-194. doi: 10.1080/10428194.2016.1189548. Epub 2016 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	140 mg	Oral

Indications

No indication recorded.