A Phase 1 Open-Label Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects with Moderate Hepatic Impairment Compared to Matched Control Subjects with Normal Hepatic Function

MAPS is sponsoring a Phase 1, open-label study of MDMA’s effect on hepatic impairment (liver disease). While the study site is prepared, this study has not yet enrolled any participants and enrollment is on hold due to COVID-19. The primary objective of this study is to evaluate the effect of moderate hepatic impairment on the pharmacokinetics of oral MDMA and its active metabolite 3,4-methylene-dioxyamphetamine (MDA). The secondary objective of this study is to evaluate the effect of moderate hepatic impairment on the safety and tolerability of oral MDMA.