Bioavailability and Bioequivalence Assessment of Niraparib and Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Patients

The primary objective of this study is to evaluate the relative **bioavailability** (BA) of a low-strength fixed-dose combination (FDC) tablet formulation of **niraparib** plus **abiraterone acetate** (AA) compared to niraparib and AA co-administered as single agents after a single dose administration. Additionally, the study aims to assess the **bioequivalence** (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. This investigation is clinically relevant as it seeks to determine the pharmacokinetic properties of these formulations in men with **metastatic castration-resistant prostate cancer (mCRPC)**, potentially impacting treatment regimens and patient outcomes.

The clinical trial involves a total of **100 participants** diagnosed with **metastatic castration-resistant prostate cancer (mCRPC)**. The study population is exclusively male, with an age range that includes adults and older adults. Participants were selected based on specific criteria, although the principal inclusion criteria are not provided. The trial does not include a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits are not specified. The sponsor has not provided detailed information regarding the general health status of the participants.

The clinical trial is designed to evaluate the **bioavailability** (BA) and **bioequivalence** (BE) of a fixed-dose combination (FDC) tablet formulation of niraparib plus abiraterone acetate (AA) compared to the co-administration of these agents as single entities in men diagnosed with **metastatic castration-resistant prostate cancer** (mCRPC). This study is a Phase 2, randomized, double-blind, controlled trial. The trial is expected to commence recruitment on December 10, 2020, and is projected to conclude by December 5, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the FDC tablet or the individual agents. The trial will include multiple follow-up visits to monitor safety, efficacy, and pharmacokinetic parameters. These visits will occur at specified intervals throughout the study duration. The end-of-study visit will be conducted to perform final assessments and gather comprehensive data on the trial outcomes.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The trial aims to provide valuable insights into the pharmacological profile of the FDC formulation in the target population, contributing to the optimization of therapeutic strategies for mCRPC.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 2 study, indicating its focus on evaluating the efficacy and side effects of the intervention. The estimated recruitment start date was December 10, 2020, with an anticipated end date of December 5, 2025. Although specific primary and secondary endpoints are not detailed, Phase 2 trials typically involve measuring parameters such as symptom improvement scores, biomarker levels, or disease remission rates. These parameters are usually collected and analyzed at predetermined timepoints throughout the trial duration. The methods for measuring efficacy often include validated scales, laboratory tests, and patient-reported outcomes, ensuring a comprehensive assessment of the intervention's impact. The trial's design and execution adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy data collected.