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

NCT01715259 | Completed Phase 1

• 2 other identifiers: CR016951COU-AA-012
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Insufficiency

Keywords

Renal insufficiency; Renal impairment; End-stage renal disease; Abiraterone acetate; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Maximum observed plasma concentration of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

• Time to maximum plasma concentration of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

• Area under the concentration-time curve from time 0 to the last measurable plasma concentration of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

• Area under the concentration-time curve from time 0 to infinity of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

• Terminal phase rate constant of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

• Terminal plasma elimination half-life of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

• Oral clearance of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

• Apparent volume of distribution of abiraterone

  Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

Secondary Outcomes (1)

• Number of participants affected by an adverse event

  Up to Day 22

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

Drug: Abiraterone acetate: participants with end-stage renal disease; Drug: Abiraterone acetate: matched control participants with normal renal function

Interventions

Abiraterone acetate: participants with end-stage renal disease DRUG

abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1

Abiraterone acetate

Abiraterone acetate: matched control participants with normal renal function DRUG

abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1

Abiraterone acetate

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cougar Biotechnology, Inc.: lead

Study Sites (1)

Unknown Facility

Orlando, Florida, United States

Location

Related Publications (1)

• Marbury T, Lawitz E, Stonerock R, Gonzalez M, Jiao J, Breeding J, Haqq C, Verboven P, Stieltjes H, Yu M, Molina A, Acharya M, Chien C, Tran N. Single-dose pharmacokinetic studies of abiraterone acetate in men with hepatic or renal impairment. J Clin Pharmacol. 2014 Jul;54(7):732-41. doi: 10.1002/jcph.253. Epub 2014 Jan 17.

  PMID: 24374856 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cougar Biotechnology, Inc. Clinical Trial

  Cougar Biotechnology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: August 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

US (1)