Midomafetamine in healthy adults
A Phase 1, Single-Center, Open-Label, 2-Cohort Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Midomafetamine at Therapeutic and Supratherapeutic Doses
This trial will test midomafetamine in healthy adults to see if it is safe and how the body processes it at two dose levels.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Resilient Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT07584720 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-center, open-label study will characterize the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of midomafetamine in healthy adults. Participants will be enrolled into two sequential cohorts receiving either a therapeutic or a supratherapeutic exposure via split-dose administration (initial dose plus an additional dose 1.5 hours later). Safety monitoring includes adverse event surveillance, clinical laboratory testing, vital signs, and electrocardiographic assessments including corrected QT interval, while pharmacokinetic sampling and subjective effect measures will capture drug exposure and acute psychoactive effects. Results are intended to inform dosing, cardiac safety limits, and further clinical development rather than to determine therapeutic efficacy.
Who should consider this trial
Good fit: Healthy adults aged 18–55 with no significant medical, cardiovascular, neurological, or psychiatric conditions who pass drug and alcohol screening and can comply with study procedures.
Not a fit: People with clinically significant cardiovascular, neurological, or psychiatric disease, current substance use disorders, or those seeking treatment for a medical condition are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could define safe dosing and cardiac-safety limits to support further clinical development of midomafetamine for potential therapeutic use.
How similar studies have performed: Phase 1 safety and pharmacokinetic studies of similar psychoactive compounds have guided dosing and safety decisions in development programs, but midomafetamine itself is being newly characterized.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Overland Park, Kansas
- Dr. Vince Clinical Research — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Resilient Pharmaceuticals
- Email: ClinDevInquiries@resilientpharm.com
- Phone: 877-627-7722
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.