Study of Midomafetamine in Healthy Adults (NCT07584720) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Midomafetamine in Healthy Adults
United States32 participantsStarted 2026-04-23
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events
Timeframe: From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)