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CompletedNCT01362764Updated Nov 27, 2012

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

A Phase 1 interventional study of Abiraterone acetate suspension Formulation 1 and Abiraterone acetate suspension Formulation 2 in Healthy Volunteers, sponsored by Cougar Biotechnology, Inc.. Completed. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-27.

Sponsored by Cougar Biotechnology, Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Abiraterone Acetate
  • ZYTIGA
03

In context

Lead sponsor

Cougar Biotechnology, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    001

    Abiraterone acetate tablets Type=exact unit=mg number= 250 form=tablet route=oral use as a single dose

    Drug: Abiraterone acetate tablets

  • Other
    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

  • Other
    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

Interventions

  • DrugAbiraterone acetate suspension Formulation 1

    Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL

  • DrugAbiraterone acetate suspension Formulation 2

    Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL

  • DrugAbiraterone acetate tablets

    Type=exact, unit=mg, number= 250, form=tablet, route=oral use, as a single dose

06

What researchers measure

Primary outcomes

  1. Levels of study drug

    Time frame: Up to 55 days

Secondary outcomes

  1. Vital signs evaluations

    Time frame: Up to 55 days

  2. Adverse events

    Time frame: Up to 55 days

  3. Clinical laboratory findings, based on blood and urine tests

    Time frame: Up to 55 days

  4. Physical examination evaluations

    Time frame: Up to 55 days

  5. Electrocardiogram changes

    Time frame: Up to 55 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01362764
Lead sponsor
Cougar Biotechnology, Inc.
Responsible party
Sponsor
First posted
May 30, 2011
Start date
May 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Nov 27, 2012

Study contacts

Cougar Biotechnology, Inc. Clinical Trial
study director · Cougar Biotechnology, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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