Phase I open-label randomised two-way crossover PK study in healthy volunteers (n=14) comparing 25 mg COMP360 as a single 25 mg capsule versus five 5 mg capsules in the fed state.
Randomised-sequence, two-period crossover in healthy volunteers to assess relative oral bioavailability of COMP360 25 mg delivered as 1×25 mg versus 5×5 mg capsules; each participant receives both regimens in separate dosing periods.
Primary endpoints are plasma PK parameters for psilocin (Cmax, AUC0-24h, AUC0-inf); secondary endpoints include additional PK metrics, safety assessments (AEs, vitals, ECG, labs), and psychiatric measures including C-SSRS and BPRS+.
Single 25 mg COMP360 capsule (test); one dosing period of crossover.
1 x 25 mg capsule; fed state.
Five 5 mg COMP360 capsules (reference); one dosing period of crossover.
5 x 5 mg capsules; fed state.