Effect of Carbamazepine on Plasma Pharmacokinetics of Verducatib in Healthy Male Volunteers

The primary objective is to assess the impact of carbamazepine administration on the systemic exposure of verducatib in healthy male volunteers, quantified by plasma concentration measurements, to determine whether enzyme induction alters the pharmacokinetic profile of verducatib, which is critical for anticipating drug‑drug interaction potential in clinical practice.

The trial enrolled healthy volunteers meeting a general health status of no known medical conditions; participants were required to be male. The sponsor did not provide the total number of participants or a specific age range. Selection was based on screening for overall health and the absence of chronic disease, with eligibility limited to individuals classified as healthy. No specific dietary, physical activity, or habit-related criteria were reported, and standard exclusion criteria such as the presence of any medical condition were applied.

The investigation is a Phase 3, Category 1 clinical trial evaluating the effect of carbamazepine on the plasma concentration of verducatib in healthy male volunteers. Participants undergo an initial screening visit to confirm eligibility, followed by a baseline assessment and administration of the study medication. Subsequent scheduled visits include mid‑study safety and pharmacokinetic assessments and a final end-of-study visit to collect concluding data. The overall participant involvement extends from the screening appointment through the end-of-study visit, encompassing the entire trial period between the projected start date of 14 September 2026 and the projected completion date of 20 December 2026. Early termination may occur if a participant experiences a serious adverse event, withdraws consent, or fails to meet compliance criteria required for continued study participation.