Phase 1 Open-Label Single-Dose Mass Balance and Metabolite Profiling Study of 14C-Labeled Izicopan (INF904) in Healthy Male Participants

This phase 1, open-label study involves a single dose of 14C-labeled izicopan in healthy male participants. The primary objective is to conduct a mass balance assessment and metabolite profiling. These evaluations are clinically significant for determining the excretion pathways and the metabolic transformation of the investigational compound. The trial scope is categorized under pharmacokinetics (6).

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers. The cohort is composed of males within the age range coded as 3. No further information concerning lifestyle considerations, selection processes, or specific inclusion and exclusion criteria was provided.

This is a Phase 1, open-label, single-dose study designed to evaluate mass balance and metabolite profiling of 14C-labeled izicopan (INF904). The research methodology involves the administration of a single dose to healthy male participants. The study procedures include a screening visit to assess eligibility, followed by the dosing period and subsequent follow-up visits to monitor metabolic processes. The study concludes with an end-of-study visit. The expected duration of participant involvement is determined by the required monitoring period following the single dose administration. Early termination from the study may occur based on predefined safety or protocol criteria.

The provided source material does not contain information regarding the parameters, methods, or tools used to evaluate efficacy. Consequently, no description of efficacy assessment can be provided.