Phase 1 Open-Label Study of Absorption, Distribution, Metabolism, and Excretion of [14C]-Vafidemstat in Healthy Male Volunteers

This phase 1, open-label study is designed to evaluate the pharmacokinetics of a single oral dose of [14C]-vafidemstat in healthy male participants. The primary objective is to assess the absorption, distribution, metabolism, and excretion of the radiolabeled compound. Furthermore, the study aims to determine the mass balance of the drug. These evaluations are essential for characterizing the systemic exposure and disposition of the investigational product.

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 corresponding to code 3. No further details regarding lifestyle considerations or specific inclusion and exclusion criteria were provided.

This is a Phase 1, open-label study designed to evaluate the pharmacokinetics of a single oral dose of [14C]-vafidemstat. The research methodology focuses on assessing absorption, distribution, metabolism, and excretion, including a mass balance assessment. The study involves healthy volunteers. The clinical trial sequence includes a screening visit, followed by study visits to monitor the metabolic processes, and an end-of-study visit. The estimated duration of recruitment and study activities is from July 1, 2026, to August 7, 2026.

The provided information does not contain details regarding the efficacy assessment parameters, measurement methods, schedules, or tools for this clinical trial.