Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 administra...
Detailed Description
This is an open-label (both \[participants and investigator\] know what treatment participants will receive) and multicenter study. The study consists of 3 phases: a screening phase (approximately 3 w...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01863784
Start Date
April 1 2013
End Date
November 1 2013
Last Update
May 12 2016
Active Locations (3)
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1
Orlando, Florida, United States
2
Knoxville, Tennessee, United States
3
San Antonio, Texas, United States