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

NCT02730975 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-01-11

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Ignacio Durán Martínez, MD-PhD · Hospital Universitario Virgen del Rocío, Seville, Spain

  • Clara Rosso Fernández, MD-PhD · Hospital Universitario Virgen del Rocío, Seville, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730975 on ClinicalTrials.gov