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

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).

Timeline

Start

2020-11-13

Primary completion

2021-10-15

Completion

2027-12-31

Outcome

Met primary endpoint

paper The RS-DAT met BE criteria (range 80%-125%) versus SAC based on 90% CI of GMR for Cmax,ss and AUC 0-24h,ss. PMID 38436924 ↗

paper The LS-DAT was considered BE to SAC on the basis of the niraparib component meeting the BE criteria in the primary analysis for AUC 0-72h; PMID 38436924 ↗

Publications

• Yu A, Hazra A, Jiao JJ, Hellemans P, Mitselos A, Tian H, Ruixo JJP, Haddish-Berhane N, Ouellet D, Russu A. Demonstrating Bioequivalence for Two Dose Strengths of Niraparib and Abiraterone Acetate Dual-Action Tablets Versus Single Agents: Utility of Clinical Study Data Supplemented with Modeling and Simulation. Clin Pharmacokinet. 2024 Apr;63(4):511-527. doi: 10.1007/s40262-023-01340-5. Epub 2024 Mar 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abiraterone acetate	Small molecule	1000 mg	Oral
Subject	Niraparib	Small molecule	100 mg	Oral
Subject	Niraparib	Small molecule	200 mg	Oral
Background	Prednisone	Other / unclassified	5 mg	Oral

Indications