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Phase 1 Study of Midomafetamine in Healthy Adults

This study is looking at the safety of a drug called midomafetamine HCl in healthy adults. It will also help us understand how your body processes the drug and what effects it has. We are testing two different doses of midomafetamine HCl. To join, you need to be a healthy adult between 18 and 55 years old. The main goal is to see how many side effects (adverse events) people experience. The current status of this study is unclear, and it plans to enroll 32 participants.

Study design
This is a Phase 1, single-center, open-label study with 32 participants. Participants will be enrolled into one of two groups, receiving either a therapeutic or a supratherapeutic dose of midomafetamine HCl.
What's involved
You will receive midomafetamine HCl in two doses, about 1.5 hours apart. You will have clinical assessments, lab tests, heart monitoring (electrocardiograms), and monitoring for side effects.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects from the time you agree to participate until your final visit, which is about 30 days after the study ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07584720

Study of Midomafetamine in Healthy Adults

Active, Not Recruiting
PHASE1Ages 18–55InterventionalBasic science
Resilient Pharmaceuticals
~32 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:Midomafetamine HCl

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events
Measured over From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)

Conditions

Healthy Volunteers

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Healthy Volunteers

NCT07584720

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Dr. Vince Clinical Research

    Overland Park, Kansasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Adverse EventsFrom signing of informed consent through End of Study visit (Day 30 +/- 2 Days)

    Assessment of adverse events and serious adverse events following administration of midomafetamine.