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Hepatic ImpairmentPhase 1NCT01516047

A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function

A Phase 1 study testing Cohort 1 and Cohort 2 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 evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing recommendations for this subpopulation. Read more about this study

Who is it for?
Ages 35 to 80 years, men only
Conditions the study is for
Hepatic Impairment
What is being tested?
Cohort 1 and Cohort 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
3 sitesUnited States
Study dates
Jan 2012to Sep 2012
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 35 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All participants are to be cancer free and have a body mass index (BMI) between 18 kg/m2 to 40 kg/m2, inclusive, and body weight not less than 50 kg.
  • Cohort 1is characterized by severe hepatic impairment (as described by the Child-Pugh Classification C).
  • Cohort 2 represents a matched control characterized by healthy participants with normal hepatic function.
  • Control cohort participants will be age matched ± 10 years and BMI matched within 20% of the means of the severe hepatic impairment cohort; no other clinical criteria will be matched.
  • Control cohort participants must be in good health, with no clinically significant findings from medical history, physical examination, laboratory evaluations, 12-lead electrocardiogram and vital signs.
  • Patients with hepatic impairment are required to be on medication and/or treatment regimen to treat their underlying hepatic impairment or medical conditions before dosing with study drug.

Who cannot join

  • Participants in the control cohort who test positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies will not be permitted to enroll in the study.
  • Patients with hepatic impairment who have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor will be excluded from participating in the study.
  • Patients with hepatic impairment taking antiviral therapy for treatment of active hepatitis infection at the time of screening, previously diagnosed with hepatocellular carcinoma, or who have a history of biliary sepsis within the past 2 years.
  • Patients with severe hepatic impairment should not have Gilbert's syndrome or >= Grade 3 hepatic encephalopathy where the patient lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Anaheim, California

  • Study site

    Orlando, Florida

  • Study site

    San Antonio, Texas

Other trials in United States

About this study

Official title: An Open-Label Pharmacokinetic Study of Abiraterone Acetate Suspension in Subjects With Severe Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function

The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing recommendations for this subpopulation.

Read the detailed description

This is a non-randomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 2-cohort study of abiraterone acetate in approximately 16 adult men. Participants will either have severe hepatic impairment (Cohort 1) or qualify for the control group with normal hepatic function (Cohort 2). This study will consist of a screening period followed by a 4-day open-label treatment phase and subsequently a 28-day follow up after the study dose of abiraterone acetate suspension. Patients will be admitted to the study center on Day -1, a single dose of study drug will be administered on the morning of Day 1, and patients will remain at the study center until completion of the 72-hour pharmacokinetic (PK; study of what the body does to a drug) blood sample collection in the morning of Day 4. Enrollment will begin sequentially with patients in the severe hepatic impairment cohort. Enrollment for Cohort 1 will be staggered in order to evaluate safety and tolerability. The study will not proceed if >=Grade 3 toxicity or serious adverse events considered related to abiraterone acetate are observed. Additional patients may be enrolled if at least 8 patients in each cohort do not complete the required assessments, including the PK blood sample collections. The aim will be to treat the remaining patients in Cohort 1 at a suspension dose yielding an exposure equivalent to 1000 mg tablet in healthy individuals. If the dose is adjusted after Study Evaluation Team review, additional patients may be enrolled to ensure at least 8 patients complete the study at the final dose. Once enrollment of patients in the severe hepatic impairment cohort is completed, the matched-control cohort will be dosed. Serial PK samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study.

Being tested
Cohort 1, Cohort 2
Keywords
Hepatic impairment, Pharmacology, Pharmacokinetics, Pharmacodynamics, Abiraterone acetate suspension, JNJ-212082

What participants receive

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

  • Cohort 1Drug

    125 mg to 2000 mg abiraterone acetate suspension on Day 1

  • Cohort 2Drug

    2000 mg abiraterone acetate suspension on Day 1

Study groups in NCT01516047
Study groupRoleWhat they receive
Cohort 1ExperimentalPatients with severe hepatic impairment.
Receives: Drug: Cohort 1
Cohort 2ExperimentalHealthy individuals with normal hepatic function.
Receives: Drug: Cohort 2

What is being measured

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

  1. Mean plasma concentrations of abiraterone

    Measured: Up to Day 4

  2. Mean plasma protein binding concentrations of abiraterone

    Measured: Screening Day -2

  3. Maximum plasma concentrations of abiraterone

    Measured: Up to Day 4

  4. Time to reach the maximum plasma concentration of abiraterone

    Measured: Up to Day 4

  5. Area under the plasma concentration-time curve from time 0 to 24 hours after dosing of abiraterone

    Measured: Up to Day 4

  6. Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone

    Measured: Up to Day 4

  7. Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone

    Measured: Up to Day 4

  8. Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone

    Measured: Up to Day 4

  9. Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone

    Measured: Up to Day 4

  10. Time to last quantifiable plasma concentration of abiraterone

    Measured: Up to Day 4

  11. Total apparent clearance of drug after extravascular administration uncorrected for absolute bioavailability of abiraterone

    Measured: Up to Day 4

  12. Apparent volume of distribution after extravascular administration uncorrected for absolute bioavailability of abiraterone

    Measured: Up to Day 4

Secondary outcomes (1)

  1. The number of participants affected by an adverse event

    Measured: Up to Day 29

Timeline

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

  1. First posted24 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2012
  4. Study completionSep 2012

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01516047
Sponsor's protocol ID
CR100779
Other IDs
212082PCR1004
Status last verified
Jun 2014
First submitted
19 Jan 2012
Last updated
25 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Marbury T, Lawitz E, Stonerock R, Gonzalez M, Jiao J, Breeding J, Haqq C, Verboven P, Stieltjes H, Yu M, Molina A, Acharya M, Chien C, Tran N. Single-dose pharmacokinetic studies of abiraterone acetate in men with hepatic or renal impairment. J Clin Pharmacol. 2014 Jul;54(7):732-41. doi: 10.1002/jcph.253. Epub 2014 Jan 17.

    PubMed 24374856

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cohort 1 and Cohort 2 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 6 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 25 Jun 2014. 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?

Mean plasma concentrations of abiraterone (time frame: Up to Day 4). The study lists 12 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 NCT01516047, which also lists 1 linked publication.

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 25 Jun 2014.

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