NCT01863784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

May 23, 2013

Last Update Submit

May 10, 2016

Conditions

Hepatic Impairment

Keywords

Hepatic ImpairmentMild and moderate hepatic impairmentNormal hepatic functionPharmacokineticsJNJ-38518168

Outcome Measures

Primary Outcomes (4)

  • 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])

  • 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])

  • 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])

  • 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])

Secondary Outcomes (6)

  • 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])

  • 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])

  • 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])

  • 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])

  • Plasma protein binding of JNJ-38518168

    Day 1 (postdose [4 hours]) and Day 14 (predose, postdose [4 hours])

  • +1 more secondary outcomes

Study Arms (1)

JNJ-38518168

EXPERIMENTAL
Drug: JNJ-38518168

Interventions

JNJ-38518168DRUG

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

JNJ-38518168

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

May 29, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(3)