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

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02001571

Run by

Cougar Biotechnology, Inc.

People needed

24

Starts

2009-08-01

Expected to finish

2010-04-01

Last updated by the study team

2013-12-05

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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