A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and matched control Participants with normal hepatic function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cougar Biotechnology, Inc.
• Treatments: Abiraterone Acetate

Criteria

Inclusion Criteria:

• Non smokers or light smokers and willing to limit smoking for the period of confinement to 4 cigarettes per day

• Body Mass Index of 18-35 kg/m2

• Negative test for breathalyzer alcohol and drugs of abuse and HIV antibody test at Screening

• Agrees to protocol-defined use of effective contraception

• Participants with Mild or Moderate Hepatic Impairment

• Must have mild or moderate hepatic impairment

• On a stable dose of medication and/or treatment regimen for at least 2 weeks before dosing as well as during the study

• Clinical laboratory evaluations within the reference range for the test laboratory

• Participants with normal hepatic function have no clinically significant findings from medical history, physical examination, Laboratory values within protocol defined parameters

Exclusion Criteria:

• Any other investigational study drug trial within 5 half-lives of that investigational study drug or 30 days prior to dosing with Abiraterone acetate, whichever is longer

• Inability to swallow four (4) 250 mg abiraterone acetate tablets

• History of or current clinically significant medical illness that would potentially alter absorption and/or excretion of orally administered drugs

• History or presence of a clinically significant abnormal ECG

• Donation of blood or significant loss of blood within 56 days prior to Day 1 or planned donation of blood or plasma from Screening through 30 days after Day 1

• Use of any prescription medications/products or any OTC, non-prescription unrelated to existing allowable stable medical conditions within 5 half-lives of that product or 7 days prior to dosing with abiraterone acetate, whichever is longer

• Clinically significant renal laboratory findings

• Participants with Mild or Moderate Hepatic Impairment will be excluded - any significant medical history other than hepatic impairment that may affect the interpretation of the data or which otherwise contraindicates participation in the study

• 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 within 2 weeks

• Autoimmune liver disease; Esophageal variceal bleeding within 6 months prior to Screening, unless successfully treated with banding, Gastric varices

• Spontaneous bacterial peritonitis within 3 months prior to Screening

• Portosystemic shunt, Organ transplant, Wilson's disease, Cholestatic liver disease (e g , primary biliary cirrhosis or primary sclerosing cholangitis)

• Clinically significant laboratory findings except as related to hepatic impairment

• Control Participants with Normal Hepatic Function Any significant laboratory results, including specifically Positive for Hepatitis B or C, Hemoglobin < 12 0 g/dL LFTs outside of normal limits