Study of Midomafetamine in Healthy Adults

This Phase 1 study is designed to evaluate the safety and tolerability of midomafetamine in healthy adult participants. The study will also assess how the drug is processed in the body and characterize its effects following administration at two dose levels, including evaluation of cardiac safety using electrocardiographic assessments. This is a single-center, open-label study in which participants will be enrolled into one of two cohorts receiving either a therapeutic dose or a supratherapeutic dose of midomafetamine. Participants will receive study drug in a split dose administration (an initial dose followed by an additional dose 1.5 hours later) and will undergo clinical assessments, laboratory testing, electrocardiographic monitoring, and monitoring for adverse events. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.

Inclusion Criteria: * Healthy adult participants, 18 to 55 years of age * Medically healthy as determined by medical history, physical examination, clinical laboratory testing, vital signs, and electrocardiogram * Able and willing to comply with study procedures Exclusion Criteria: * History of clinically significant cardiovascular, neurological, or psychiatric disease * Current or recent substance use disorder, or positive drug or alcohol screen at screening * Prior exposure to midomafetamine exceeding a protocol-defined limit intended to minimize confounding of safety assessments (no more than 10% of participants may have lifetime prior exposure) * Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with interpretation of study results