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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC

Criteria

Inclusion Criteria:

• Stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured within 48 hours prior to PCI-32765 administration

• Must be hepatically impaired as defined by the Child-Pugh classification of severity of liver disease

• Control group must have good health with normal liver function

• Participants with controlled hypertension and those with problems directly associated with the primary diagnosis of hepatic impairment

• Concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed

• Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

• Clinically significant renal laboratory findings including serum creatinine more than 1.5 x the upper limit of normal (ULN) and/or calculated creatinine clearance of less than 60 ml per minute per 1.73 square meter

• Clinically significant abnormal laboratory tests, physical examination, vital signs or electrocardiogram at screening or at admission to the study center

• Antiviral therapy for active hepatitis infection at time of screening

• Use of any anti-coagulation therapy including vitamin K antagonists, low molecular weight heparin, or other anticoagulants