- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516047
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
June 24, 2014 updated by: Janssen Research & Development, LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Anaheim, California, United States
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-
Florida
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Orlando, Florida, United States
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Texas
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San Antonio, Texas, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Patients with severe hepatic impairment.
|
125 mg to 2000 mg abiraterone acetate suspension on Day 1
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Experimental: Cohort 2
Healthy individuals with normal hepatic function.
|
2000 mg abiraterone acetate suspension on Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean plasma concentrations of abiraterone
Time Frame: Up to Day 4
|
Up to Day 4
|
Mean plasma protein binding concentrations of abiraterone
Time Frame: Screening Day -2
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Screening Day -2
|
Maximum plasma concentrations of abiraterone
Time Frame: Up to Day 4
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Up to Day 4
|
Time to reach the maximum plasma concentration of abiraterone
Time Frame: Up to Day 4
|
Up to Day 4
|
Area under the plasma concentration-time curve from time 0 to 24 hours after dosing of abiraterone
Time Frame: Up to Day 4
|
Up to Day 4
|
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of abiraterone
Time Frame: Up to Day 4
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Up to Day 4
|
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Time Frame: Up to Day 4
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Up to Day 4
|
Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
Time Frame: Up to Day 4
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Up to Day 4
|
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
Time Frame: Up to Day 4
|
Up to Day 4
|
Time to last quantifiable plasma concentration of abiraterone
Time Frame: Up to Day 4
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Up to Day 4
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Total apparent clearance of drug after extravascular administration uncorrected for absolute bioavailability of abiraterone
Time Frame: Up to Day 4
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Up to Day 4
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Apparent volume of distribution after extravascular administration uncorrected for absolute bioavailability of abiraterone
Time Frame: Up to Day 4
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Up to Day 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of participants affected by an adverse event
Time Frame: Up to Day 29
|
Up to Day 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Research, Janssen Research & Development, LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
January 19, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 24, 2012
Study Record Updates
Last Update Posted (Estimate)
June 25, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100779
- 212082PCR1004 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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