Food Effects on Bioavailability of MDMA in Healthy Volunteers (MPKF)

This Phase 1 open-label study (n=12) has the primary purpose of evaluating the food effect of a high-calorie meal as compared to fasting conditions on the relative bioavailability of oral MDMA capsules in healthy volunteers.

In addition, increases in heart rate are 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 electrocardiogram (ECG). Directly comparing the pharmacokinetics of MDMA and its active metabolite MDA, in a within-subject crossover study will allow for assessment of any impacts of food and inform product labeling.

Topic Healthy Subjects
Compound MDMA
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

MAPS PBC
MAPS Public Benefit Corporation (MAPS PBC) is the 'benefit above profit' corporation that is fully owned by MAPS.

Data attribution

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