Back to resultsA Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function
Primary Purpose
Hepatic Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JNJ-38518168
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Impairment focused on measuring Hepatic Impairment, Mild and moderate hepatic impairment, Normal hepatic function, Pharmacokinetics, JNJ-38518168
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JNJ-38518168
Arm Description
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration of JNJ-38518168 at approximately steady-state after multiple doses
Area under the plasma concentration-time curve of JNJ-38518168 at approximately steady-state after multiple doses
Time to reach the maximum observed plasma of JNJ-38518168 at approximately steady-state after multiple doses
Apparent clearance of JNJ-38518168 at approximately steady-state after multiple doses
Secondary Outcome Measures
Maximum observed plasma concentration of JNJ-38518168 after single dose
Area under the plasma concentration-time curve of JNJ-38518168 after single dose
Time to reach the maximum observed plasma of JNJ-38518168 after single dose
Urine concentration-time data of JNJ-38518168 after single dose
Plasma protein binding of JNJ-38518168
Number of participants with adverse events
Full Information
NCT ID
NCT01863784
First Posted
May 23, 2013
Last Updated
May 10, 2016
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01863784
Brief Title
A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment
Keywords
Hepatic Impairment, Mild and moderate hepatic impairment, Normal hepatic function, Pharmacokinetics, JNJ-38518168
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-38518168
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
JNJ-38518168
Intervention Description
All participants will receive JNJ-38518168 30 mg tablet once daily from Day 1 to Day 14.
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration of JNJ-38518168 at approximately steady-state after multiple doses
Time Frame
Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])
Title
Area under the plasma concentration-time curve of JNJ-38518168 at approximately steady-state after multiple doses
Time Frame
Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])
Title
Time to reach the maximum observed plasma of JNJ-38518168 at approximately steady-state after multiple doses
Time Frame
Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])
Title
Apparent clearance of JNJ-38518168 at approximately steady-state after multiple doses
Time Frame
Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration of JNJ-38518168 after single dose
Time Frame
Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])
Title
Area under the plasma concentration-time curve of JNJ-38518168 after single dose
Time Frame
Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])
Title
Time to reach the maximum observed plasma of JNJ-38518168 after single dose
Time Frame
Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])
Title
Urine concentration-time data of JNJ-38518168 after single dose
Time Frame
Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])
Title
Plasma protein binding of JNJ-38518168
Time Frame
Day 1 (postdose [4 hours]) and Day 14 (predose, postdose [4 hours])
Title
Number of participants with adverse events
Time Frame
Up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Orlando
State/Province
Florida
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Pharmacokinetics of JNJ-38518168 in Patients With Mild and Moderate Hepatic Impairment Compared With Patients With Normal Hepatic Function
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