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A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Sponsor: Janssen Research & Development, LLC
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
Conditions
Interventions
Niraparib
Niraparib will be administered orally.
Abiraterone Acetate (AA)
Abiraterone Acetate will be administered orally.
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