A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet

Healthy Participants Clinical Trial

Official title: A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 3 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Subjects

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.

Clinical Trial Description

This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), single-center, 4-way crossover study (method used to switch participants from one treatment arm to another in a clinical trial) of a single dose of abiraterone acetate (1000 mg). The study will consist of 3 phases including screening phase (of 21 days), an open-label treatment phase consisting of 4 single-dose treatment periods, and follow-up phase. All participants will be randomly assigned to 1 of 4 possible treatment sequences to ensure that they receive all of the following treatments, one in each period. The 4 sequences are as follows: Sequence 1: Treatment A, D, B, and C; Sequence 2: Treatment B, A, C, and D; Sequence 3: Treatment C, B, D, and A; and Sequence 4: Treatment D, C, A, and B. After a washout period of 7 days, follow-up phase will occur between 5 to 7 days after the last study procedure. The duration of participation in the study for each participant is from 47 days to a maximum of 68 days (including screening). Pharmacokinetics will be measured by collection of blood samples. Participants will be confined to the study center until completion of the 96 hour pharmacokinetic assessments on Day 5 of each treatment period. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examinations will be monitored throughout the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Participants

• NCT number: NCT01640093
• Study type: Interventional
• Source: Janssen Research & Development, LLC
• Status: Completed
• Phase: Phase 1
• Start date: May 2012
• Completion date: July 2012