drugset / Trial / NCT02730975

Pharmacokinetic Food-effect Study of Abiraterone Acetate (AA) in Castration Resistant Prostate Cancer

NCT02730975

RandomizedParallel-groupOpen-labelTreatment

Summary

ABIFOOD study is a randomized open-labelled, phase I study to evaluate food effect in the pharmacokinetic parameters of abiraterone acetate (AA) at reduced doses, versus AA in fasting conditions at conventional doses, in castration resistant prostate cancer (mCRPC) patients who have progressed to docetaxel.

Timeline

Start
2014-05-12
Primary completion
2020-10-10
Completion
2020-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 250 mg Oral
Subject Abiraterone acetate Small molecule 1000 mg Oral

Indications