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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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abiraterone acetate
Sponsored by
Cougar Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Abiraterone acetate, Pharmacokinetics

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Mild Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.

Moderate Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.

Normal Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration of abiraterone acetate

Secondary Outcome Measures

The number of Participants with adverse events

Full Information

First Posted
October 31, 2013
Last Updated
November 28, 2013
Sponsor
Cougar Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02001571
Brief Title
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
Official Title
A Phase 1 Single Dose Open-Label Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cougar Biotechnology, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This is an open-label (identity of assigned study drug will be known) pharmacokinetics and safety study of abiraterone acetate administered as four 250 mg tablets (1000 mg) to 3 cohorts (groups) in Cohort 1 (Mild Hepatic Impairment), Cohort 2 (Moderate Hepatic Impairment) and Cohort 3 (Normal Hepatic Function). There will be approximately 8 Participants per cohort (total of approximately 24 Participants for the study). The cohorts will be dosed sequentially and activities will consist of Screening, Study and Follow-up periods, a total of up to approximately 36 days. Possible Participants will be screened to assess their eligibility to enter the study within 14 days prior to study Day 1. Participants will be confined at the Clinical Research Center (CRC) from the time of Check-in on Day -1 until discharge on Day 5. Participants will return to the CRC on Days 8 and 15 and there will be a follow-up call or visit on Day 22. A review of all clinical and laboratory data through Day 8 evaluations in each cohort will be done by the Medical Monitor and the Principal Investigator (PI) prior to proceeding with dosing any further cohort, if indicated. Safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Abiraterone acetate, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Mild Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Moderate Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Normal Hepatic participants administered to four 250 mg tablets (1000 mg) orally on Day 1.
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate
Intervention Description
On the morning of Day 1, each participant was given four 250 mg tablets of abiraterone acetate with 240 mL of room temperature tap water. Dosing followed at least a 10-hour fast from food (not including water).
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration of abiraterone acetate
Time Frame
Up to 96 hours postdose
Secondary Outcome Measure Information:
Title
The number of Participants with adverse events
Time Frame
Approximately 36 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cougar Biotechnology, Inc. Clinical Trial
Organizational Affiliation
Cougar Biotechnology, Inc.
Official's Role
Study Director
Facility Information:
City
Orlando
State/Province
Florida
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24374856
Citation
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.
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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

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