NCT01715259

A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function

A Phase 1 Single Dose Open-Label Reduced/Staged Pharmacokinetic Study of Abiraterone Acetate in Male Subjects With Impaired Renal Function Compared to Matched Control Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Cougar Biotechnology, Inc. · Industry
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal function compared to individuals with normal renal function.

Detailed description

This is an open-label (identity of assigned study drug will be known) pharmacokinetics study evaluating a single dose of abiraterone acetate 1000 mg administered in male participants with end-stage renal disease compared to matched-control (matched for age and body mass index) participants with normal renal function. There will be approximately 8 participants in each cohort (group). The total study duration for each participant will be 36 days. Abiraterone acetate 1000 mg will be administered orally (by mouth) as a single dose in the fasted state on Day 1. No food will be ingested for 4 hours post-dose. Participants will be confined to the clinical research center from the day prior to dosing (Day -1) to Day 5 and will return to the clinic on Days 8, 15, and 22 for follow up. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Abiraterone acetate: participants with end-stage renal disease	abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
DRUG	Abiraterone acetate: matched control participants with normal renal function	abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2012-10-26
• Last updated: 2012-11-19

Locations

1 site across 1 country: United States