Phase I, open-label, randomized crossover study assessing the pharmacokinetics and food effect of Iadademstat in healthy volunteers

The primary objective is to characterize the pharmacokinetics of Iadademstat in healthy adult volunteers and to determine the impact of a standard high‑fat meal on its absorption, distribution, metabolism, and excretion.

The trial enrolled both male and female healthy volunteers within the age categories designated by codes 3 and 4; however, the sponsor did not provide the total number of participants. Selection criteria were based on inclusion of individuals without known medical conditions, and participants were required to meet general health standards typical for healthy volunteer studies. No specific lifestyle restrictions or requirements, such as diet or physical activity, were detailed in the available information, and no additional inclusion or exclusion criteria were disclosed.

The Phase 3, Category 1 study in healthy volunteers assesses the pharmacokinetic profile of Iadademstat and the influence of food on its absorption; participants undergo an initial screening visit to confirm eligibility, followed by a single‑dose administration visit under fed or fasted conditions, subsequent follow‑up visits scheduled at predefined intervals to collect blood and urine samples for PK analysis, and a final end‑of‑study visit to complete safety assessments; total participant involvement spans approximately three and a half months from the first screening appointment to the end‑of‑study visit, with recruitment projected from 1 September 2026 to 15 December 2026; subjects may be withdrawn for medically significant adverse events, protocol non‑compliance, or voluntary discontinuation, constituting early termination criteria.

No information regarding experimental medication, comparator, or administration details was provided in the source data.