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Hepatic ImpairmentPhase 1NCT01863784

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

A Phase 1 study testing JNJ-38518168 in people with Hepatic Impairment, run by Janssen Research & Development, LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatic Impairment
What is being tested?
JNJ-38518168
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesUnited States
Study dates
Apr 2013to Nov 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Knoxville, Tennessee

  • Study site

    Orlando, Florida

  • Study site

    San Antonio, Texas

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
JNJ-38518168
Keywords
Hepatic Impairment, Mild and moderate hepatic impairment, Normal hepatic function, Pharmacokinetics, JNJ-38518168
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-38518168Drug

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

Study groups in NCT01863784
Study groupRoleWhat they receive
JNJ-38518168ExperimentalNot described
Receives: Drug: JNJ-38518168

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma concentration of JNJ-38518168 at approximately steady-state after multiple doses

    Measured: Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])

  2. Area under the plasma concentration-time curve of JNJ-38518168 at approximately steady-state after multiple doses

    Measured: Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])

  3. Time to reach the maximum observed plasma of JNJ-38518168 at approximately steady-state after multiple doses

    Measured: Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])

  4. Apparent clearance of JNJ-38518168 at approximately steady-state after multiple doses

    Measured: Day 14 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, and 96 hours])

Secondary outcomes (6)

  1. Maximum observed plasma concentration of JNJ-38518168 after single dose

    Measured: Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])

  2. Area under the plasma concentration-time curve of JNJ-38518168 after single dose

    Measured: Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])

  3. Time to reach the maximum observed plasma of JNJ-38518168 after single dose

    Measured: Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])

  4. Urine concentration-time data of JNJ-38518168 after single dose

    Measured: Day 1 (predose, postdose [1, 2, 3, 4, 5, 6, 7, 8, 12, and 24 hours])

  5. Plasma protein binding of JNJ-38518168

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

  6. Number of participants with adverse events

    Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01863784
Sponsor's protocol ID
CR101336
Other IDs
38518168ARA1005
Status last verified
May 2016
First submitted
23 May 2013
Last updated
12 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-38518168 in people with Hepatic Impairment, run by Janssen Research & Development, LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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])). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01863784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.

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