Effect of Enzalutamide, Apalutamide, and Bicalutamide on the Pharmacokinetics of Fezolinetant in Men with Prostate Cancer and Associated Hot Flashes

This study evaluates the pharmacokinetic interaction between enzalutamide, apalutamide, or bicalutamide and fezolinetant in men diagnosed with prostate cancer. The primary objective is to determine how these specific androgen receptor inhibitors affect the metabolism and systemic exposure of fezolinetant. This assessment is clinically relevant to understand potential alterations in drug concentrations that may influence the management of hot flashes.

The sponsor did not provide information regarding the total number of participants. The study population consists of male patients and healthy volunteers. The age range is defined by codes 3 and 4. The participants are characterized by the presence or absence of hot flush.

This Phase 3 clinical trial is designed to evaluate the effects of enzalutamide, apalutamide, and bicalutamide on the pharmacokinetics of fezolinetant in men diagnosed with prostate cancer experiencing hot flush. The study utilizes a controlled research methodology to determine how these specific medications influence the metabolic processing of the target compound. The sequence of procedures begins with a screening visit to assess eligibility. Following inclusion, participants undergo scheduled follow-up visits to monitor physiological responses and drug interactions. The process concludes with an end-of-study visit. Total participant involvement is determined by the clinical assessment period, though participation may be discontinued early if specific medical criteria or safety protocols are met. The estimated recruitment period for this study is from February 2026 to October 2026.

The assessment of efficacy in this phase 3 clinical trial focuses on the management of hot flushes. Efficacy evaluation is conducted through specific parameters and standardized methodologies to determine the clinical impact of the investigational product.