Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT01715259
Brief 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.
Study:
NCT01715259
Study Brief:
Protocol Section:
NCT01715259