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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions
Renal Insufficiency
Interventions
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

Trial Locations (1)

Unknown

Orlando

Sponsors
All Listed Sponsors
lead

Cougar Biotechnology, Inc.

INDUSTRY