A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function

Completed · Phase 1

Conditions studied: Renal Insufficiency

In brief

The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function.

Key facts

Study ID

NCT01715259

Run by

Cougar Biotechnology, Inc.

People needed

16

Starts

2009-08-01

Expected to finish

2010-01-01

Last updated by the study team

2012-11-19

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• All participants:
• Non-smokers or light smokers
• Body Mass Index of 18-38 kg/m2 inclusive
• Negative drug test, at screening and Day -1, for breathalyzer alcohol and drugs of abuse
• Negative HIV antibody test at screening
• Clinical laboratory values within protocol-defined parameters
• Agrees to protocol-defined use of effective contraception
• Participants may have concurrent stable medical conditions and may be included if the deemed condition(s) will not introduce an additional risk factor and will not interfere with the study objectives and procedures
• Patients with renal impairment must additionally meet the following criteria:
• Must have protocol-defined criteria of end-stage renal disease, moderate or mild renal impairment
• Evidence of stable renal impairment
• Control participants with normal renal function must additionally meet the following criteria:
• Must be in good health

You may not qualify if…

• All participants:
• Medical history of malignancy except non-melanoma skin cancer
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives of that drug or 30 days prior to dosing with abiraterone acetate, whichever is longer
• History of alcoholism or drug abuse within the past 12 months
• Significant history or clinical manifestation as determined by the Investigator of any significant metabolic, allergic, dermatological, hepatic, hematological, pulmonary, cardiovascular, immunologic, neurological, psychiatric or gastrointestinal conditions, surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• Clinically significant arrhythmias and/or history or presence of a clinically significantly abnormal electrocardiogram
• Acute illness, especially any active and uncontrolled infection
• Not willing to refrain from strenuous exercise from 48-hours prior to Day -1 and during the period of confinement at the clinical site
• Not willing to abstain from consuming: grapefruit- or caffeine-containing foods or beverages for 72 hours prior to Day -1 and alcohol-containing foods or beverages for 24 hours prior to Day -1
• 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, inclusive
• The use of any prescription or over-the-counter (OTC) preparation known to significantly inhibit or induce liver enzymes involved in drug metabolism within 30 days prior to Day 1
• Use of any prescription medications/products or any OTC, non-prescription preparations 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
• Any acute or chronic condition that, in the opinion of the Investigator, would limit the individual's ability to complete and/or participate in this clinical study
• Patients with renal impairment who meet any of the following criteria will be excluded from the study:
• Acute or exacerbating renal disease, fluctuating or rapidly deteriorating renal function as indicated by widely varying or worsening of signs of renal impairment within 2 weeks of Day 1
• Hypertension (systolic blood pressure [BP] >180 or diastolic BP >100)
• Control participants with normal renal function who meet any of the following criteria will be excluded from the study:
• Hypertension (systolic BP >=160 or diastolic BP >=95)
• Any significant laboratory results consistent with renal impairment

Where it is running

• Study site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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