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Clinical Trial Active — Not Recruiting Phase I NCT04577833

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

A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer — Active Not Recruiting • Phase I • Oncology • NCT04577833.

📅 13 Apr 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase I
NCT ID
NCT04577833
Start
2020-11-13
Completion
2021-10-15
ClinicaliQ Trial Snapshot
  • A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer — Active Not Recruiting • Phase I • Oncology • NCT04577833.
  • This trial compares different formulations of niraparib and abiraterone acetate to ensure they work similarly in men with advanced prostate cancer.

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What This Trial Is Studying

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). Conditions: Prostatic Neoplasms Interventions: Niraparib, Abiraterone Acetate (AA), Prednisone Lead Sponsor: Janssen Research & Development, LLC Planned Enrollment: 136 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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