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Study of Midomafetamine in Healthy Adults

7. maj 2026 opdateret af: Resilient Pharmaceuticals

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 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66212
        • Rekruttering
        • Dr. Vince Clinical Research
        • Kontakt:
        • Ledende efterforsker:
          • William Lavery, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Midomafetamine HCl
Midomafetamine HCl is administered orally to study participants.
Andre navne:
  • Midomafetamin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Adverse Events
Tidsramme: From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in corrected QT interval (QTc) (ms)
Tidsramme: Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
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.
Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
Maximum plasma concentration (Cmax) of midomafetamine
Tidsramme: Predose (Day 1) through 48 hours postdose (Day 3)
Plasma midomafetamine concentrations will be measured, and maximum plasma concentration (Cmax) will be derived from the concentration-time data.
Predose (Day 1) through 48 hours postdose (Day 3)
Time to maximum plasma concentration (Tmax) of midomafetamine
Tidsramme: Predose (Day 1) through 48 hours postdose (Day 3)
Plasma midomafetamine concentrations will be measured, and time to maximum plasma concentration (Tmax) will be derived from the concentration-time data.
Predose (Day 1) through 48 hours postdose (Day 3)
Area under the plasma concentration-time curve (AUC0-24) of midomafetamine
Tidsramme: Predose (Day 1) through 24 hours postdose (Day 2)
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.
Predose (Day 1) through 24 hours postdose (Day 2)
Change from baseline in subjective effects Visual Analog Scale (VAS) scores
Tidsramme: Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
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.
Baseline (predose Day 1) and up to 24 hours postdose (Day 2)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Resilient Pharmaceuticals

Samarbejdspartnere

Dr. Vince Clinical Research

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. april 2026

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

30. juli 2026

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RP-CL-P1-2501

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data collected in this study will not be shared. Summary level results may be reported in publications and regulatory submissions, as applicable.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Midomafetamine HCl

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