Study of Midomafetamine in Healthy Adults

Phase 1RecruitingNCT07584720

Resilient Pharmaceuticals32 enrolled

Overview

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.

This Phase 1 study is a dedicated safety investigation conducted in healthy adult participants to further characterize the safety and tolerability of midomafetamine under controlled dosing conditions. Participants will receive a split dose administration of midomafetamine (an initial dose of study drug followed by an additional dose 1.5 hours later) in sequential dose cohorts intended to achieve therapeutic and supratherapeutic systemic exposure. Safety assessments include monitoring of adverse events, clinical laboratory tests, vital signs, and electrocardiographic measurements. Electrocardiographic data, including assessment of corrected QT interval, will be collected to support evaluation of cardiac safety in relation to exposure. Because midomafetamine produces acute psychoactive effects during the dosing period, pharmacodynamic assessments-including subjective effects-will be collected to support interpretation of safety and tolerability findings. Pharmacokinetic assessments will also be performed to characterize systemic exposure. This study is not designed to evaluate efficacy or treatment effectiveness for any disease or condition. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Adverse Events

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

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

Secondary Outcomes

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

Corrected QT interval (QTc) will be assessed using 12-lead ECG data and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.

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

Maximum plasma concentration (Cmax) of midomafetamine

Plasma midomafetamine concentrations will be measured, and maximum plasma concentration (Cmax) will be derived from the concentration-time data.

Time frame: Predose (Day 1) through 48 hours postdose (Day 3)

Time to maximum plasma concentration (Tmax) of midomafetamine

Plasma midomafetamine concentrations will be measured, and time to maximum plasma concentration (Tmax) will be derived from the concentration-time data.

Time frame: Predose (Day 1) through 48 hours postdose (Day 3)

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

Plasma midomafetamine concentrations will be measured, and area under the concentration-time curve from time 0 to 24 hours (AUC0-24) will be derived from the concentration-time data.

Time frame: Predose (Day 1) through 24 hours postdose (Day 2)

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

Subjective effects will be assessed using Visual Analog Scale (VAS) instruments and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.

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

Study of Midomafetamine in Healthy Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts