A study in healthy male volunteers to investigate how the test medicine COMP360 [14C]-psilocybin is taken up, broken down and removed from the body

Open-label, non-randomised single-dose mass-balance study of COMP360 [14C]-psilocybin in healthy males to assess absorption, distribution, metabolism and excretion with urine and faecal collections up to Day 10 and blood PK through Day 8.

Endpoints include plasma and excreta radioactivity recovery, metabolite profiling, PK parameters for psilocin and metabolites, safety assessments (AEs, ECG, vitals, labs), C-SSRS and BPRS+ up to Day 10, and 5D-ASC and psychedelic intensity ratings on Day 1.