drugset / Trial / NCT05147402

Food Effects on Bioavailability of MDMA in Healthy Volunteers

NCT05147402

Phase 1 Completed 14 enrolled Resilient Pharmaceuticals
RandomizedCrossoverOpen-labelBasic science

Summary

The goal of this clinical trial is to learn if food impacts absorption of MDMA in participants who are either fed or fasted. The main question it aims to answer is: What is the effect of eating food on the safety of taking oral MDMA? Researchers will compare participants who are fasted for 10 hours to participants who are fed a high-fat and high-calorie meal. Participants will be randomized to either the fed or fasted group, then be administered MDMA. Vitals and blood samples will be taken. Then, participants will be assigned to the opposite condition and vitals and blood samples will be taken.

Timeline

Start
2022-07-28
Primary completion
2022-12-02
Completion
2022-12-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midomafetamine Unknown 100 mg Oral

Indications

No indication recorded.