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

NCT04577833 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-05-08

No results posted yet for this 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

  • Prostatic Neoplasms

Interventions

DRUG

Niraparib

Niraparib will be administered orally.

DRUG

Abiraterone Acetate (AA)

Abiraterone Acetate will be administered orally.

DRUG

Prednisone

Prednisone will be administered orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2021-10-15
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Georgia
  • Moldova
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577833 on ClinicalTrials.gov