UW Psilocybin Pharmacokinetics Study
Phase I single-group pharmacokinetics study (n=12) of oral psilocybin in healthy adults, ascending doses 0.3 → 0.45 → 0.6 mg/kg with attended dosing and overnight sampling.
Details
This Phase I study determined the pharmacokinetics of an extemporaneous oral psilocybin formulation in healthy adults to support later phase trials in clinical populations.
Participants received three single-dose psilocybin administrations (0.3, 0.45, 0.6 mg/kg) separated by a minimum of four weeks; each session included an attended 0–8 hour outpatient period and overnight 8–24 hour sampling in the clinical research unit.
Safety monitoring included 12-lead ECGs at specified time points, continuous attendance by two trained monitors during drug action, and physician availability throughout the 24 hour observation period; blood and urine samples were collected for PK analyses.