NCT01362764

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 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cougar Biotechnology, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-05-30
• Last updated: 2012-11-27