Overview

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

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Abiraterone Acetate
Criteria
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.