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CompletedPhase 1

Food Effects on Bioavailability of MDMA in Healthy Volunteers

NCT05147402 · MPKF · Resilient Pharmaceuticals

Closed to entry
Status
Not accepting participants
Phase 1
Phase
14
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Area under the curve from dosing time to last measurement - Plasma concentration of MDMA

    Measured over 0 to 1 day after drug administration

  • Area under the curve from dosing time to last measurement - Plasma concentration of active metabolite MDA

    Measured over 0 to 1 day after drug administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Are fluent in speaking and reading the predominantly used or recognized language of the study site. * Are able to swallow pills. * If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 7 days after the last Experimental Session. Exclusion Criteria: * Are not able to give adequate informed consent. * Have uncontrolled hypertension. * Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds \[ms\] corrected by Bazett's formula). * Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). * Have evidence or history of significant medical disorders. * Have symptomatic liver disease. * Have history of hyponatremia or hyperthermia. * Weigh less than 48 kilograms (kg). * Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control. * Are abusing illegal drugs.

Where

1 study site

FacilityCityRegionCountry
Alliance for Multispecialty Research LLCKnoxvilleTennesseeUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05147402 on ClinicalTrials.gov →

Last updated in the registry 2024-10-30. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits