Study of Midomafetamine in Healthy Adults

NCT07584720 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: RP-CL-P1-2501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Midomafetamine; Phase 1 Study; Healthy Volunteers; Safety; Pharmacokinetics; Pharmacodynamics; ECG

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

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

  From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)

Secondary Outcomes (5)

• Change from baseline in corrected QT interval (QTc) (ms)

  Baseline (predose Day 1) and up to 24 hours postdose (Day 2)

• Maximum plasma concentration (Cmax) of midomafetamine

  Predose (Day 1) through 48 hours postdose (Day 3)

• Time to maximum plasma concentration (Tmax) of midomafetamine

  Predose (Day 1) through 48 hours postdose (Day 3)

• Area under the plasma concentration-time curve (AUC0-24) of midomafetamine

  Predose (Day 1) through 24 hours postdose (Day 2)

• Change from baseline in subjective effects Visual Analog Scale (VAS) scores

  Baseline (predose Day 1) and up to 24 hours postdose (Day 2)

Study Arms (1)

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.

Drug: Midomafetamine HCl

Interventions

Midomafetamine HCl DRUG

Midomafetamine HCl is administered orally to study participants.

Also known as: Midomafetamine

Experimental

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Resilient Pharmaceuticals: lead
• Dr. Vince Clinical Research: collaborator

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 13, 2026
• Study Start: April 23, 2026
• Primary Completion: July 23, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)