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ACTIVE NOT RECRUITING Phase 1

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

NCT04577833 · View on ClinicalTrials.gov ↗

Study 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).

Conditions Studied

Interventions

  • DRUG Prednisone
  • DRUG Niraparib
  • DRUG Abiraterone Acetate (AA)

Study Locations (16)

Other

  • Universitair Ziekenhuis Gent — Ghent
  • GZA Ziekenhuizen- Campus St Augustinus — Wilrijk
  • Institut Bergonié, Centre de Lutte Contre le Cancer — Bordeaux
  • HIA Begin — Saint-Mandé
  • Arensia Exploratory Medicine — Tbilisi
  • Arensia Exploratory Medicine — Chisinau
  • Erasmus MC — Rotterdam
  • Uniwersyteckie Centrum Kliniczne — Gdansk
  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy — Warsaw
  • Hosp Univ Fund Jimenez Diaz — Madrid
  • Hosp Univ Hm Sanchinarro — Madrid
  • Hosp Virgen de La Victoria — Málaga
  • Karolinska Universitetssjukhuset Solna — Stockholm
  • ARENSIA Exploratory Medicine Unit — Kyiv
  • Sir Bobby Robson Unit, Northern Centre for Cancer Care — Newcastle upon Tyne

Utah

  • START Mountain Region — West Valley City

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2020-11-13
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04577833

The ClinicalTrials.gov registry entry for NCT04577833 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04577833 reports 16 study locations spanning 2 distinct geographic areas — top geographies include Other, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04577833 about?

NCT04577833 is a clinical study titled "A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer". 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-r...

What is the current status of trial NCT04577833?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2020-11-13. Estimated completion is 2026-12-31.

What conditions does trial NCT04577833 study?

This clinical trial studies the following conditions: Prostatic Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04577833?

The interventions under investigation include: Prednisone (DRUG), Niraparib (DRUG), Abiraterone Acetate (AA) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04577833?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04577833 being conducted?

This trial has 16 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial