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

Hepatic Impairment Clinical Trial

Official title:

An Open-Label Study to Evaluate the Pharmacokinetics of Multiple Oral Doses of 30 mg JNJ-38518168 in Subjects With Mild and Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863784
• Other study ID #: CR101336
• Secondary ID: 38518168ARA1005
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2013
• Last updated: May 26, 2015
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: May 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

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 weeks), a treatment phase (from day -2 [2 days before the administration of study medication] to Day 18), and an end-of-study phase (7 to 10 days after the last dose of study medication). Approximately 24 participants (participants with mild hepatic impairment, moderate hepatic impairment, and normal liver function) will receive JNJ-38518168 for 14 days. Hepatic impairment will be evaluated according to Child-Pugh score. It consists of 5 clinical measures (amount of ascites [an abnormal accumulation of fluid in the abdomen], total bilirubin [mg/dL], albumin [g/dL], international normalized ratio, and degree of encephalopathy [abnormal functioning of the brain]). Each is scored from 0 (less severity) to 3 (highest severity). Total Child-Pugh score is the sum of all subscores and is graded as: mild (5-6 points), moderate (7-9 points), and severe (10-15 points). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, body weight, physical examination, and 12-lead electrocardiogram which will be monitored at various timepoints throughout the study. The total duration of study participation for each participant is approximately 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• JNJ-38518168
All participants will receive JNJ-38518168 30 mg tablet once daily from Day 1 to Day 14.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration of JNJ-38518168 at approximately steady-state after multiple doses		Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])	No
Primary	Area under the plasma concentration-time curve of JNJ-38518168 at approximately steady-state after multiple doses		Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])	No
Primary	Time to reach the maximum observed plasma of JNJ-38518168 at approximately steady-state after multiple doses		Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])	No
Primary	Apparent clearance of JNJ-38518168 at approximately steady-state after multiple doses		Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])	No
Secondary	Maximum observed plasma concentration of JNJ-38518168 after single dose		Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])	No
Secondary	Area under the plasma concentration-time curve of JNJ-38518168 after single dose		Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])	No
Secondary	Time to reach the maximum observed plasma of JNJ-38518168 after single dose		Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])	No
Secondary	Urine concentration-time data of JNJ-38518168 after single dose		Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])	No
Secondary	Plasma protein binding of JNJ-38518168		Day 1 (postdose [4 hours]) and Day 14 (predose, postdose [4 hours])	No
Secondary	Number of participants with adverse events		Up to 6 weeks	Yes