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

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 12, 2014

Primary Completion Date

October 10, 2020

Study Completion Date

October 10, 2020

Conditions
Prostate Cancer
Interventions
DRUG

AA Reduced dose-normal diet (A)

Cycles of 28 days length of AA at reduced doses (250 mg) administered with a pre-defined normal diet, described with specific caloric and fat content.

DRUG

AA reduced dose-fat diet (B)

Cycles of 28 days length of AA at reduced doses (250 mg) administered with a pre-defined fat diet, described with specific caloric and fat content.

DRUG

AA normal dose-fasting conditions (C)

Cycles of 28 days length of AA at approved doses (1000 mg) administered in fasting conditions.

Trial Locations (1)

41013

Hospital Universitario Virgen del Rocío, Seville

All Listed Sponsors
lead

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

NCT02730975 - Pharmacokinetic Food-effect Study of Abiraterone Acetate (AA) in Castration Resistant Prostate Cancer | Biotech Hunter | Biotech Hunter