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NCT04577833 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.

Active
Registry status
Phase 1
Development phase
136
Enrollment target
16
Study locations

NCT04577833 is a Phase 1 study of Prostatic Neoplasms that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 136 participants, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (73% lower). The trial reports 16 study locations across 2 states.

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The verdict

NCT04577833, a Phase 1 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
136 participants
Enrollment target
16
Study locations

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

Prostatic Neoplasms

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

593 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, categorized as Phase 1. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (73% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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.

NCT04577833 reports 16 study locations spanning 2 distinct geographic areas - top geographies include Other, Utah.

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.

What interventions are being tested in trial NCT04577833?

The interventions under investigation include: Prednisone (DRUG), Niraparib (DRUG), Abiraterone Acetate (AA) (DRUG).

Who is sponsoring clinical trial NCT04577833?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.