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

Sex: Male

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE1

Enrollment: 136

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).

Eligibility Criteria

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Diagnosed with metastatic castration-resistant prostate cancer (mCRPC), who in the opinion of the investigator may benefit from treatment in this study * Able to continue gonadotropin-releasing hormone analogues (GnRHa) therapy during the study if not surgically castrate (that is, participants who have not undergone bilateral orchiectomy) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04577833). StuddyBuddy aggregates publicly available trial information.