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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT01516047

Run by

Janssen Research & Development, LLC

People needed

16

Starts

2012-01-01

Expected to finish

2012-09-01

Last updated by the study team

2014-06-25

Who can join

Age: 35 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Orlando, Florida, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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