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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: Active Phase 1 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Cmax,ss is defined as maximum observed analyte concentration at steady state.
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
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04577833 still lists
NCT04577833 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (73% lower).
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 lists 16 locations in 2 states (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.
Learn More About Clinical Trials
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Where NCT04577833's enrollment target sits among peer trials
136 35th of 65 higher than 31 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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