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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
Unnamed facility
Orlando, Florida, United States
Maximum observed plasma concentration of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Time to maximum plasma concentration of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve from time 0 to the last measurable plasma concentration of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Area under the concentration-time curve from time 0 to infinity of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Terminal phase rate constant of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Terminal plasma elimination half-life of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Oral clearance of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
Apparent volume of distribution of abiraterone
Time frame: Within 0.5 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of participants affected by an adverse event
Time frame: Up to Day 22