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To assess the relative BA of a low-strength FDC tablet formulation of niraparib plus AA compared to niraparib and AA co-administered as single agents after single dose administration and to assess BE of a regular strength FDC tablet formulation of niraparib plus AA compared to niraparib and AA co-administered as single agents at steady state in men with prostate cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508150-26-00
Acronym
67652000PCR1001
Enrollment
41
Registered
2024-05-06
Start date
2020-11-26
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration-resistant prostate cancer (mCRPC)

Interventions

None listed

Sponsors

Janssen Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Countries

Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026