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NCT05147402 · ClinicalTrials.gov registry record · Phase 1
Food Effects on Bioavailability of MDMA in Healthy Volunteers
A Phase 1 study, sponsored by Resilient Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT05147402: Completed Phase 1 study, sponsored by Resilient Pharmaceuticals.
NCT05147402 is a Phase 1 study that has completed, run by Resilient Pharmaceuticals. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05147402, a Phase 1 study, has completed, sponsored by Resilient Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
Computed exposure to MDMA using blood collected periodically at pre-dose as well as 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 12 hours post drug administration.
Interventions
- DRUG midomafetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-07-28 |
| Est. Completion | 2022-12-05 |
| Phase | Phase 1 |
What the finished NCT05147402 record still lists
NCT05147402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which midomafetamine is the first listed.
NCT05147402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05147402 about?
NCT05147402 is a clinical study titled "Food Effects on Bioavailability of MDMA in Healthy Volunteers". 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 hour...
What is the current status of trial NCT05147402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-07-28. Estimated completion is 2022-12-05.
What interventions are being tested in trial NCT05147402?
The interventions under investigation include: midomafetamine (DRUG).
Who is sponsoring clinical trial NCT05147402?
This trial is sponsored by Resilient Pharmaceuticals, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05147402's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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