Active, not recruitingPhase 1

Study of Midomafetamine in Healthy Adults

NCT07584720 · Resilient Pharmaceuticals

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

1 US states

What it is testing

Summary

This Phase 1 study is designed to evaluate the safety and tolerability of midomafetamine in healthy adult participants. The study will also assess how the drug is processed in the body and characterize its effects following administration at two dose levels, including evaluation of cardiac safety using electrocardiographic assessments. This is a single-center, open-label study in which participants will be enrolled into one of two cohorts receiving either a therapeutic dose or a supratherapeutic dose of midomafetamine. Participants will receive study drug in a split dose administration (an initial dose followed by an additional dose 1.5 hours later) and will undergo clinical assessments, laboratory testing, electrocardiographic monitoring, and monitoring for adverse events. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.

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

Incidence of Adverse Events
Measured over From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)

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 55 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Healthy adult participants, 18 to 55 years of age * Medically healthy as determined by medical history, physical examination, clinical laboratory testing, vital signs, and electrocardiogram * Able and willing to comply with study procedures Exclusion Criteria: * History of clinically significant cardiovascular, neurological, or psychiatric disease * Current or recent substance use disorder, or positive drug or alcohol screen at screening * Prior exposure to midomafetamine exceeding a protocol-defined limit intended to minimize confounding of safety assessments (no more than 10% of participants may have lifetime prior exposure) * Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with interpretation of study results

Where

1 study site

Facility	City	Region	Country
Dr. Vince Clinical Research	Overland Park	Kansas	United 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.

NCT07584720 on ClinicalTrials.gov →

Last updated in the registry 2026-06-29. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

MDMA

Recruiting in

Kansas9

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