A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

The purpose of this study is to characterize the pharmacokinetics (what the body does to the study medication) of JNJ-38518168 at approximately steady-state (stable medication levels) after administration of multiple oral 30 mg doses of JNJ-38518168 to participants with mild or moderate hepatic (liver) impairment (abnormal function) compared with participants with normal hepatic function.

Key facts

Study ID

NCT01863784

Run by

Janssen Research & Development, LLC

People needed

28

Starts

2013-04-01

Expected to finish

2013-11-01

Last updated by the study team

2016-05-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have normal liver function for the normal hepatic function group
• Have mild or moderate liver diseases as defined by the Child-Pugh Classification and be clinically stable overall for the mild or moderate liver disease groups
• Doses of drugs used to treat other illnesses or conditions related to liver disease must be stable for at least 4 weeks before the first dose of study medication with the exception of thyroid replacement hormone, in which case the dose must be stable for 3 months before the first dose of study medication. Doses of these drugs must also be stable during the course of the study
• If an illness with a fever occurs within one week of the start of dosing, dosing must be postponed until the body temperature is normal for at least 72 hours
• Participants must agree to use one of the contraception methods defined in the protocol

You may not qualify if…

• Hepatic insufficiency secondary to autoimmune hepatitis or obstructive liver disease
• Allergy to heparin or history of heparin-induced thrombocytopenia
• All participants must have a negative human immunodeficiency virus test. Participants with normal liver function must test negative for hepatitis B and hepatitis C
• Severe ascites (an abnormal accumulation of fluid in the abdomen) or severe pleural effusion (fluid around the lungs)

Where it is running

• Study site — Orlando, Florida, United States
• Study site — Knoxville, Tennessee, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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