[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100332304":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":38,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":38,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":38,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":83,"whyStopped":38,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Resilient Pharmaceuticals","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Moderate hepatic impairment","EXPERIMENTAL","Eight participants with moderate hepatic impairment receive a single dose of 80 mg midomafetamine HCl.",[13],"Drug: Midomafetamine HCl",{"label":15,"type":10,"description":16,"interventionNames":17},"Normal hepatic function","Eight participants, each matched on age, weight and gender to a participant with moderate hepatic impairment, receive a single dose of 80 mg midomafetamine HCl.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Midomafetamine HCl","80 mg midomafetamine HCl",[9,15],[25,26,27,28],"MDMA","3,4-methylenedioxymethamphetamine","midomafetamine","MDMA HCl",[30],{"name":31,"affiliation":32,"role":33},"Janel Long-Boyle, PharmD, PhD","University of California, San Francisco","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":38,"email":39},"Recruitment Officer","CONTACT",null,"recruitment@lykospbc.com",[41],{"facility":42,"status":38,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Alliance for Multispecialty Research, LLC.","Knoxville","Tennessee","37920","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-83.92074,35.96064,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":38,"email":38},"Study coordinator",{"type":58,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100332304","phase-1-mdma-in-subjects-with-moderate-hepatic-impairment-and-subjects-with-normal-hepatic-function-100332304",false,"NCT03606538","MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function","A Phase I, Open Label, Study of 3,4-Methylenedioxymethamphetamine (MDMA) Tolerability and Pharmacokinetics in Subjects With Moderate Hepatic Impairment Compared to Matched Control Subjects With Normal Hepatic Function","Inclusion Criteria:\n\n* Participants with moderate hepatic impairment (class B according to Child- Pugh's criteria).\n* Participants with normal hepatic function: no clinically significant findings from medical history, physical examination, laboratory values within protocol defined parameters.\n* Age 18 to 65 years.\n* Weight \\> 45 kg\n* Negative Carbohydrate Deficient Transferrin blood test at Screening and negative breathalyzer alcohol test prior to trial drug administration.\n* Negative urine test for drugs of abuse at Screening and prior to trial drug administration.\n* Able to comprehend and willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Have a current psychiatric diagnosis.\n* Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control.\n* Have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and\u002For laboratory signs of hepatic impairment within 2 weeks.\n* Have autoimmune liver disease; esophageal variceal bleeding within 6 months prior to screening, unless successfully treated with banding, or gastric varices.\n* Have spontaneous bacterial peritonitis within 3 months prior to screening.\n* Have a portosystemic shunt, organ transplant, Wilson's disease, cholestatic liver disease (e g, primary biliary cirrhosis or primary sclerosing cholangitis)\n* Evidence or history of significant hematological, endocrine, cerebrovascular, cardiovascular (including controlled hyper-tension), coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration.\n* For moderate hepatic impairment participants: have clinically significant laboratory findings except as related to hepatic impairment.\n* For control participants only: have clinically significant laboratory results outside the normal limits, including AST \\>48 U\u002FL, ALT \\> 55 U\u002FL, GGT \\> 48 U\u002FL, bilirubin \\> 1.2 mg\u002FdL or hemoglobin \\\u003C 12 g\u002FdL.\n* Have a history of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject.\n* Have any positive test for drugs of abuse and \u002For alcohol at screening.\n* Have a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of \\> 450 ms in men, \\> 470 ms in women on the screening ECG.\n* Have a PR interval \\> 240 ms, QRS \\> 110 ms or a history of prolongation of QT interval.\n* Have mental incapacity, unwillingness or language barriers precluding adequate understanding or subject co-operation.\n* Are unwilling to stay in the clinical unit for the required duration as per the protocol.\n* Have a known or suspected allergy to trial product or related products.",true,"ALL","18 Years","65 Years",{"count":71,"type":72},16,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function.\n\nThe main questions it aims to answer are:\n\nDo people with abnormal liver function experience greater absorption of MDMA? Does the dose of MDMA need to be adjusted in people with abnormal liver function?\n\nResearchers will compare people with abnormal liver function to people with normal liver function.\n\nParticipants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.",[78,79],"Pharmacokinetics","Hepatic Impairment",[25,81,82,27],"metabolism","methylenedioxymethamphetamine","NOT_YET_RECRUITING","2024-10-28",{"date":86,"type":87},"2024-10-30","ACTUAL",{"date":89,"type":72},"2026-03-29",{"date":91,"type":72},"2028-12",{"name":5,"class":6},1]