[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07584720":3,"trial-entities:NCT07584720":97,"trial-summary:NCT07584720":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":42,"secondary_outcomes":47,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":81,"locations":83,"central_contacts":93,"overall_officials":94,"references":95,"see_also_links":96},"NCT07584720","RP-CL-P1-2501","Study of Midomafetamine in Healthy Adults","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","ACTIVE_NOT_RECRUITING","2027-02-28","2026-06","2026-06-29","2026-04-23","Resilient Pharmaceuticals","INDUSTRY",false,"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.\n\nThis 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.\n\nInformation 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.\n\nSafety 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.\n\nBecause 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.\n\nThis 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.",[19],"Healthy Volunteers",[21,22,19,23,24,25,26],"Midomafetamine","Phase 1 Study","Safety","Pharmacokinetics","Pharmacodynamics","ECG","INTERVENTIONAL","BASIC_SCIENCE",[30],"PHASE1",{"count":32,"type":33},32,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"DRUG","Midomafetamine HCl","Midomafetamine HCl is administered orally to study participants.",[40],"Experimental",[21],[43],{"measure":44,"description":45,"timeFrame":46},"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 +\u002F- 2 Days)",[48,52,56,59,63],{"measure":49,"description":50,"timeFrame":51},"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.","Baseline (predose Day 1) and up to 24 hours postdose (Day 2)",{"measure":53,"description":54,"timeFrame":55},"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.","Predose (Day 1) through 48 hours postdose (Day 3)",{"measure":57,"description":58,"timeFrame":55},"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.",{"measure":60,"description":61,"timeFrame":62},"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.","Predose (Day 1) through 24 hours postdose (Day 2)",{"measure":64,"description":65,"timeFrame":51},"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.","ALL","18 Years","55 Years",true,{"inclusion":71,"exclusion":75,"raw_text":80},[72,73,74],"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",[76,77,78,79],"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","Inclusion Criteria:\n\n* Healthy adult participants, 18 to 55 years of age\n* Medically healthy as determined by medical history, physical examination, clinical laboratory testing, vital signs, and electrocardiogram\n* Able and willing to comply with study procedures\n\nExclusion Criteria:\n\n* History of clinically significant cardiovascular, neurological, or psychiatric disease\n* Current or recent substance use disorder, or positive drug or alcohol screen at screening\n* 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)\n* Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with interpretation of study results",[82],"ADULT",[84],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Dr. Vince Clinical Research","Overland Park","Kansas","66212","United States",{"lat":91,"lon":92},38.98223,-94.67079,[],[],[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[19],[],{"nct_id":4,"found":69,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is a Phase 1, single-center, open-label study with 32 participants. Participants will be enrolled into one of two groups, receiving either a therapeutic or a supratherapeutic dose of midomafetamine HCl.","completed","Phase 1 Study of Midomafetamine in Healthy Adults","This study is looking at the safety of a drug called midomafetamine HCl in healthy adults. It will also help us understand how your body processes the drug and what effects it has. We are testing two different doses of midomafetamine HCl. To join, you need to be a healthy adult between 18 and 55 years old. The main goal is to see how many side effects (adverse events) people experience. The current status of this study is unclear, and it plans to enroll 32 participants.","You will be monitored for side effects from the time you agree to participate until your final visit, which is about 30 days after the study ends.",86,"You will receive midomafetamine HCl in two doses, about 1.5 hours apart. You will have clinical assessments, lab tests, heart monitoring (electrocardiograms), and monitoring for side effects.","Not stated in the trial record.",[37],"v2"]