Mdma molecule:

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Mdma Clinical Trials

A Phase 1, Single Center, Open Label, Randomized Sequence, 2-period Cross-over Study to Determine the Effect of Food on the Relative Bioavailability of 3,4-methylenedioxymethamphetamine (MDMA) Oral Formulation in Healthy Volunteers

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Id: NCT05147402

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Recruiting

Start Date: July 27, 2022

Last Update: July 29, 2022

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: This protocol is a Phase 1 open-label study with a 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.

  • Pharmacokinetics

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