Food Effects on Bioavailability of MDMA in Healthy Volunteers

The sponsor has completed a Phase 3 study of MDMA-assisted therapy for individuals diagnosed with severe PTSD demonstrating the safety and efficacy of this treatment. However, the effect of food intake on the absorption and bioavailability of orally administered MDMA is not yet well characterized.

This phase I, open-label, randomized sequence, multi-dose, 2-period crossover pharmacokinetic (PK) study assesses the effect of food on the relative bioavailability of MDMA. In addition, an increase in heart rate is anticipated following MDMA administration. Therefore, the secondary purpose of this study is to evaluate the effect of food on the safety and tolerability of oral MDMA, as well as MDMA effects on ECG.

Potential participants will be identified by the clinical site and invited to phone screen for the study. Following informed consent, potential study participants will undergo screening examinations to assess eligibility for inclusion in the study.

Participants will be randomized to receive one of two conditions before the other:

• Fasted Treatments: 10 hours of fasting followed by MDMA administration with 240 mL water.
• Fed Treatments: A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will be consumed within 30 minutes of MDMA administration.

Participants will be confined at the Clinical Research Unit (CRU) for each Dosing Session from the time of check-in on the night before dosing until discharge 48 hours after dosing. MDMA will be administered on Day 1 following the treatment sequence to which the participant has been randomized. Concentration-time profiles of MDMA will be determined in the time interval 0-72 hours post-dose, according to the expected PK profiles of MDMA and its metabolites. Participants will remain at the CRU for at least 36 hours after administration of study drug for collection of serial blood samples for PK analysis and safety monitoring. An additional outpatient visit will occur 72 hours after dosing to collect a final PK sample and perform safety assessments.