A Phase I, Open Label, Study of 3,4-methylenedioxymethamphetamine (MDMA) Food Effect
This phase I, open-label, randomized sequence, multi-dose, 2-period crossover pharmacokinetic (PK) study will assess the effect of food on the relative bioavailability of MDMA in up to 12 participants.
Participants will be randomized to receive one of two conditions before the other, followed by various blood samples for pharmacokinetic analysis and safety monitoring:
- 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.