Study of Midomafetamine in Healthy Adults

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Resilient Pharmaceuticals
Study ID
NCT07584720
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Midomafetamine HCl — DRUG
    Midomafetamine HCl is administered orally to study participants.

Study Details

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.

Key Dates

First listed
May 13, 2026
Start date
Apr 23, 2026
Status verified
Jun 2026
Primary completion
Jul 23, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Experimental
    Participants receive midomafetamine administered in sequential dose cohorts. One cohort receives a targeted therapeutic dose administered in a split manner, and a subsequent cohort receives a supratherapeutic dose administered in a split manner.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: From signing of informed consent through End of Study visit (Day 30 +/- 2 Days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dr. Vince Clinical ResearchOverland ParkKansas66212-

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By research site
Dr. Vince Clinical Research· Overland Park, KS

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