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

NCT01362764 | Completed Phase 1

• 2 other identifiers: CR018067212082HPL1001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Keywords

Abiraterone Acetate; ZYTIGA

Outcome Measures

Primary Outcomes (1)

• Levels of study drug

  Up to 55 days

Secondary Outcomes (5)

• Vital signs evaluations

  Up to 55 days

• Adverse events

  Up to 55 days

• Clinical laboratory findings, based on blood and urine tests

  Up to 55 days

• Physical examination evaluations

  Up to 55 days

• Electrocardiogram changes

  Up to 55 days

Study Arms (3)

001

OTHER

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

Drug: Abiraterone acetate tablets

002

OTHER

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

003

OTHER

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

Abiraterone acetate suspension Formulation 1 DRUG

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

002

Abiraterone acetate suspension Formulation 2 DRUG

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

003

Abiraterone acetate tablets DRUG

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

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cougar Biotechnology, Inc.: lead

MeSH Terms

Interventions

Abiraterone Acetate

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: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: May 30, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 27, 2012

Record last verified: 2012-11