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Study of Midomafetamine in Healthy Adults

NCT07584720 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Midomafetamine HCl

Midomafetamine HCl is administered orally to study participants.

Sponsors & Collaborators

  • Dr. Vince Clinical Research

    collaborator OTHER

  • Resilient Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-23
Primary Completion
2026-07-30
Completion
2026-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584720 on ClinicalTrials.gov