A Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01362764
First received: May 27, 2011
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to compare the single-dose pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body) of the solution formulation to the tablet formulation; therefore the lowest dose available in the tablet formulation (250 mg) was selected.


Condition Intervention Phase
Healthy Volunteers
Drug: Abiraterone acetate suspension Formulation 1
Drug: Abiraterone acetate suspension Formulation 2
Drug: Abiraterone acetate tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation Under Fasted Condition in Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Cougar Biotechnology, Inc.:

Primary Outcome Measures:
  • Levels of study drug [ Time Frame: Up to 55 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs evaluations [ Time Frame: Up to 55 days ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Up to 55 days ] [ Designated as safety issue: Yes ]
  • Clinical laboratory findings, based on blood and urine tests [ Time Frame: Up to 55 days ] [ Designated as safety issue: Yes ]
  • Physical examination evaluations [ Time Frame: Up to 55 days ] [ Designated as safety issue: Yes ]
  • Electrocardiogram changes [ Time Frame: Up to 55 days ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001
Abiraterone acetate tablets Type=exact unit=mg number= 250 form=tablet route=oral use as a single dose
Drug: Abiraterone acetate tablets
Type=exact, unit=mg, number= 250, form=tablet, route=oral use, as a single dose
002
Abiraterone acetate suspension Formulation 1 Type=exact unit=mg/mL number=25 form=oral suspension route=oral use as a single dose of 10 mL
Drug: Abiraterone acetate suspension Formulation 1
Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL
003
Abiraterone acetate suspension Formulation 2 Type=exact unit=mg/mL number=25 form=oral suspension route=oral use as a single dose of 10 mL
Drug: Abiraterone acetate suspension Formulation 2
Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL

Detailed Description:

This is an open-label (volunteer and study staff will know the identity of the assigned treatment) study of two abiraterone acetate suspension formulations, compared to the abiraterone acetate tablet formulation in healthy volunteers. Approximately 30 healthy volunteers will participate in this study. Each volunteer will be randomly assigned to 1 of 6 possible treatment sequences. The study consists of a screening phase (within 21 days before the first study drug administration of the first period); an open-label treatment phase consisting of 3 single dose treatment periods; and end-of-study or withdrawal assessments done upon completion of the 72-hour (Day 4 of Period 3, or upon withdrawal) sampling to evaluate how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. A 7- to 14-day washout period will separate the study drug administrations. The duration of participation in the study for an individual healthy volunteer will be from 41 days to a maximum of 55 days (including screening). Safety will be monitored. Volunteers will receive a 250 mg dose of abiraterone acetate as a tablet, suspension Formulation 1, and suspension Formulation 2 according to their treatment sequence. Abiraterone acetate tablets must be swallowed whole and not chewed, divided, dissolved or crushed and will be taken with 240 mL of noncarbonated water. For the suspensions, the volunteer will drink the contents of the vial. The vial will be rinsed with 10 mL of water, and the volunteer will be asked to drink the rinse water.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having signed an informed consent document
  • Agreeing to use an adequate contraception method, as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
  • Body mass index (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
  • Blood pressure (after the volunteer is sitting for 5 minutes) between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic during screening Days -21 to Day -1
  • Having a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
  • Morphology consistent with healthy cardiac conduction and function

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled
  • History of, or a reason to believe a volunteer has a history of drug or alcohol abuse within the past 2 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362764

Sponsors and Collaborators
Cougar Biotechnology, Inc.
Investigators
Study Director: Cougar Biotechnology, Inc. Clinical Trial Cougar Biotechnology, Inc.
  More Information

No publications provided

Responsible Party: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01362764     History of Changes
Other Study ID Numbers: CR018067, 212082HPL1001
Study First Received: May 27, 2011
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cougar Biotechnology, Inc.:
Abiraterone Acetate
ZYTIGA

ClinicalTrials.gov processed this record on October 23, 2014