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ACTIVE NOT RECRUITING
NCT04577833
PHASE1

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

Official title: An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2020-11-13

Completion Date

2026-12-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

Niraparib

Niraparib will be administered orally.

DRUG

Abiraterone Acetate (AA)

Abiraterone Acetate will be administered orally.

DRUG

Prednisone

Prednisone will be administered orally.

Locations (16)

START Mountain Region

West Valley City, Utah, United States

Universitair Ziekenhuis Gent

Ghent, Belgium

GZA Ziekenhuizen- Campus St Augustinus

Wilrijk, Belgium

Institut Bergonié, Centre de Lutte Contre le Cancer

Bordeaux, France

HIA Begin

Saint-Mandé, France

Arensia Exploratory Medicine

Tbilisi, Georgia

Arensia Exploratory Medicine

Chisinau, Moldova

Erasmus MC

Rotterdam, Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp Univ Hm Sanchinarro

Madrid, Spain

Hosp Virgen de La Victoria

Málaga, Spain

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

ARENSIA Exploratory Medicine Unit

Kyiv, Ukraine

Sir Bobby Robson Unit, Northern Centre for Cancer Care

Newcastle upon Tyne, United Kingdom