MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function

Phase 1, open-label, parallel-group pharmacokinetic study comparing a single oral 80 mg dose of MDMA in participants with moderate hepatic impairment and matched healthy controls; intensive plasma sampling on Day 1 and additional samples on subsequent days to calculate AUC, Cmax and Tmax.

Safety and tolerability assessed via vitals, serial 12-lead ECGs, adverse events and C-SSRS; participants remain in clinic for three days with follow-ups on days 8 and 15.