[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07540494":3,"trial-entities:NCT07540494":109,"trial-summary:NCT07540494":113},{"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":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":71,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":86,"locations":88,"central_contacts":101,"overall_officials":106,"references":107,"see_also_links":108},"NCT07540494","GH001-HV-109","Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects","An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System in Healthy Subjects","NOT_YET_RECRUITING","2026-05","2026-04","2026-04-20","GH Research Ireland Limited","INDUSTRY",null,"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.",[17],"Healthy Adult",[19,20,21,22,23,24],"Mebufotenin","5-MeO-DMT","5-methoxy-N,N-dimethyltryptamine","GH001","Healthy volunteers","Pharmacokinetics","INTERVENTIONAL","TREATMENT",[28],"PHASE1",{"count":30,"type":31},12,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","5 Methoxy N,N Dimethyltryptamine","GH001 administered via inhalation",[22],[19,22,20],{"type":40,"name":41,"description":42,"armGroupLabels":43},"DEVICE","GH001 Aerosol Delivery System","GH001 aerosol delivery system",[22],[45,49,51,53,55,57,59,61,63,65,67],{"measure":46,"description":47,"timeFrame":48},"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.","Day 1",{"measure":50,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)",{"measure":52,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - terminal elimination half-life (t1\u002F2)",{"measure":54,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)",{"measure":56,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)",{"measure":58,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2)",{"measure":60,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)",{"measure":62,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - apparent total body clearance (CL\u002FF)",{"measure":64,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz\u002FF)",{"measure":66,"description":47,"timeFrame":48},"Serum PK parameters of mebufotenin - Cmax\u002FAUCinf",{"measure":68,"description":69,"timeFrame":70},"Safety and tolerability: incidence of treatment-emergent adverse events","Incidence of adverse events reported in the study and coded by MedDRA.","Through trial completion, an average of 3 weeks",[],"ALL","21 Years","64 Years",true,{"inclusion":77,"exclusion":81,"raw_text":85},[78,79,80],"Body mass index (BMI) in the range of 18.5 to 35 kg\u002Fm2 (inclusive) at screening.","Good mental health in the opinion of the investigator.","Normal spirometry (FEV1 of \\>80% of predicted and FVC of \\>80% of predicted value) at screening.",[82,83,84],"Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.","Has received any investigational medication, including investigational vaccines, in the 90 days prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.","Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.","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 90 days 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.",[87],"ADULT",[89],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":98},"GH Research Clinical Trial Site","Miami","Florida","33319","United States",[96],{"name":90,"role":97},"CONTACT",{"lat":99,"lon":100},25.77427,-80.19366,[102],{"name":103,"role":97,"phone":104,"email":105},"GH Research Limited Clinical Trial Enquiries","+353874503237","clinicaltrials@ghres.com",[],[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Healthy Volunteer",[],{"nct_id":4,"found":75,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study, but the phase is not specified. It plans to enroll 12 healthy adult participants.","completed","GH001 Aerosol Delivery System in Healthy Adults","This study is testing a new way to give a drug called GH001 using a special inhaler (aerosol delivery system). We want to understand how your body handles GH001 (this is called pharmacokinetics or PK) and if it's safe and well-tolerated after a single dose. We'll be looking at things like how much GH001 is in your blood and how long it stays there. You might be able to join if you are a healthy adult between 21 and 64 years old, have a healthy body weight (BMI between 18.5 and 35), good mental health, and normal lung function. The study aims to enroll 12 people. The current recruitment status is unclear.","The primary measurements for the drug in your blood are taken on Day 1.",112,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]