[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555427":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":54,"studyPopulation":54,"armGroups":62,"interventions":89,"overallOfficials":54,"centralContacts":97,"locations":103,"responsibleParty":116,"collaborators":54,"id":118,"slug":54,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":54,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":54,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":106,"whyStopped":54,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"GH Research Ireland Limited","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":54,"otherOutcomes":54},[9,13,15,17,19,21,23,25,27,29,33,36,40,44,48,51],{"measure":10,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)","For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.","Up to 6 hours",{"measure":14,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)",{"measure":16,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - terminal elimination half-life (t1\u002F2)",{"measure":18,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)",{"measure":20,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUC0-∞)",{"measure":22,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)",{"measure":24,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - apparent total body clearance (CL\u002FF)",{"measure":26,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - apparent steady-state volume of distribution (VSS\u002FF)",{"measure":28,"description":11,"timeFrame":12},"Serum PK parameters of mebufotenin - Cmax\u002FAUC0-∞",{"measure":30,"description":31,"timeFrame":32},"Safety and tolerability: incidence of treatment-emergent adverse events","Adverse events reported in the study and coded by MedDRA.","Up to 7 days",{"measure":34,"description":35,"timeFrame":32},"Safety and tolerability: clinically significant changes from baseline in electrocardiogram (ECG), vital signs, spirometry and safety laboratory assessments","Percentage of subjects with clinically significant changes\\* from baseline in ECG (heart rate, RR, QT, PR, and QRS intervals, and QTcF).\n\nPercentage of subjects with clinically significant changes\\* from baseline in vital signs (systolic and diastolic blood pressure, respiration rate, heart rate, peripheral oxygen saturation, body temperature).\n\nPercentage of subjects with clinically significant changes\\* from baseline in spirometry (forced expiratory volume in 1 second \\[FEV1\\] and forced vital capacity \\[FVC\\]).\n\nPercentage of subjects with clinically significant changes\\* from baseline in safety laboratory assessments (hematology, biochemistry, and urinalysis).\n\n\\*Clinically significant changes as determined by the principal investigator",{"measure":37,"description":38,"timeFrame":39},"Safety and tolerability: assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA\u002FS]) following each dose and as part of the discharge evaluation on Day 0","The MOAA\u002FS will be completed before and after GH001 dosing. Scored from 0 (deep sedation) to 5 (alert).","Postdose, up to discharge on dosing day (Day 0)",{"measure":41,"description":42,"timeFrame":43},"Safety and tolerability: change from baseline in Clinician Administered Dissociative States Scale (CADSS)","The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely. Summed together, these subscales form a total dissociative score. Combined score ranges from 0 to 76.","From baseline up to 7 days",{"measure":45,"description":46,"timeFrame":47},"Safety and tolerability: assessment of subject discharge readiness at discharge on Day 0","Assessment of Discharge Readiness on the administration day by the principal investigator, using the Clinical Assessment of Discharge Readiness (CADR).","Postdose, at discharge on dosing day (Day 0)",{"measure":49,"description":50,"timeFrame":32},"Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization.","A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.",{"measure":52,"description":53,"timeFrame":43},"Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).","A scale to measure psychiatric symptoms. Each symptom is rated 1-7 and a total of 18 symptoms are scored. Combined score ranges from 18 to 126 and a higher score means a worse outcome.",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":58,"primaryPurpose":59,"observationalModel":54,"timePerspective":54,"maskingInfo":60},"NON_RANDOMIZED","PARALLEL","This study will include separate single- and multiple-dose parts.\n\nPart 1 (Single-Dose Part):\n\nAn open-label, non-randomized, parallel design where subjects will be assigned to receive single doses of GH001 delivered via a proprietary aerosol delivery device on a single day in three consecutive cohorts (Cohorts A, B, and C) with eight subjects per cohort. Up to two additional cohorts (Cohorts D and E) may be added before Part 2 is initiated.\n\nPart 2 (Multiple-Dose Part):\n\nAn open-label, non-randomized design where up to three escalating doses of GH001 will be administered to subjects via a proprietary aerosol delivery device on a single day in one cohort of 12 subjects (Cohort F).","TREATMENT",{"masking":61,"maskingDescription":54,"whoMasked":54},"NONE",[63,69,73,77,81,85],{"label":64,"type":65,"description":66,"interventionNames":67},"Part 1, Cohort A","EXPERIMENTAL","A single dose inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in eight subjects.",[68],"Drug: 5 Methoxy N,N Dimethyltryptamine",{"label":70,"type":65,"description":71,"interventionNames":72},"Part 1, Cohort B","A single dose inhaled dose of 12 mg GH001 administered via a proprietary aerosol delivery device in eight subjects.",[68],{"label":74,"type":65,"description":75,"interventionNames":76},"Part 1, Cohort C","A single dose inhaled dose of 18 mg GH001 administered via a proprietary aerosol delivery device in eight subjects.",[68],{"label":78,"type":65,"description":79,"interventionNames":80},"Part 1, Cohort D (optional)","A single inhaled intermediate dose of 8, 9, 10, 14, 15, or 16 mg GH001 administered via a proprietary aerosol delivery device in eight subjects (optional cohort dependent on study safety group \\[SSG\\] review of PK, PD and safety data from Cohorts A, B, and C).",[68],{"label":82,"type":65,"description":83,"interventionNames":84},"Part 1, Cohort E (optional)","A single inhaled intermediate dose of 8, 9, 10, 14, 15, or 16 mg GH001 administered via a proprietary aerosol delivery device in eight subjects (optional cohort dependent on SSG review of PK, PD and safety data from Cohorts A, B, and C).",[68],{"label":86,"type":65,"description":87,"interventionNames":88},"Part 2, Cohort F","Up to three escalating inhaled doses of GH001 (doses as determined by Part 1, maximum single inhaled dose of 18 mg) administered via a proprietary aerosol delivery device in 12 subjects.",[68],[90],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"DRUG","5 Methoxy N,N Dimethyltryptamine","GH001 administered via inhalation",[64,70,74,78,82,86],[96],"Mebufotenin, 5-MeO-DMT, GH001",[98],{"name":99,"role":100,"phone":101,"phoneExt":54,"email":102},"GH Research Limited Clinical Trial Enquiries","CONTACT","+353 87 450 3237","clinicaltrials@ghres.com",[104],{"facility":105,"status":106,"city":107,"state":54,"zip":54,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":54},"GH Research Clinical Trial Site","RECRUITING","London","United Kingdom","UK",{"type":111,"coordinates":112},"Point",[113,114],-0.12574,51.50853,{"lat":114,"lon":113},{"type":117,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100555427",false,"NCT06511947","Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects","An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects","Inclusion Criteria:\n\n* Body mass index (BMI) in the range of 18.5 to 35 kg\u002Fm2 (inclusive) at screening\n* Good mental health in the opinion of the investigator.\n* Normal spirometry (FEV1 of \\>80% of predicted and FVC of \\>80% of predicted value) at screening.\n\nExclusion Criteria:\n\n* Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.\n* Has received any investigational medication, including investigational vaccines, in the 3 months prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.\n* Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.",true,"ALL","18 Years","64 Years",{"count":129,"type":130},52,"ESTIMATED","INTERVENTIONAL",[133],"PHASE1","The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK\u002F pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax\u002F2 and TCmax\u002F10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.",[136],"Healthy Volunteers",[138,139,140,141,142,143],"Mebufotenin","5-MeO-DMT","5-methoxy-N,N-dimethyltryptamine","GH001","Healthy volunteers","Pharmacokinetics","2024-08-06",{"date":146,"type":147},"2024-08-07","ACTUAL",{"date":149,"type":147},"2024-08-01",{"date":151,"type":130},"2025-02",{"name":5,"class":6},1]