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

NCT02001571 | Completed Phase 1

• 2 other identifiers: CR016948COU-AA-011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Abiraterone acetate; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Maximum observed plasma concentration of abiraterone acetate

  Up to 96 hours postdose

Secondary Outcomes (1)

• The number of Participants with adverse events

  Approximately 36 days

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Drug: Abiraterone acetate

Cohort 2

EXPERIMENTAL

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

Drug: Abiraterone acetate

Cohort 3

EXPERIMENTAL

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

Drug: Abiraterone acetate

Interventions

Abiraterone acetate DRUG

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).

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Cougar Biotechnology, Inc. Clinical Trial

  Cougar Biotechnology, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: December 5, 2013
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 5, 2013

Record last verified: 2013-11

Locations

US (1)