Healthy Adult
Conditions
Keywords
Mebufotenin, 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, GH001, Healthy volunteers, Pharmacokinetics
Brief summary
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.
Interventions
GH001 administered via inhalation
DEVICEGH001 Aerosol Delivery System
GH001 aerosol delivery system
Sponsors
GH Research Ireland Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - terminal elimination rate constant (λz) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - apparent total body clearance (CL/F) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F) | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Serum PK parameters of mebufotenin - Cmax/AUCinf | Day 1 | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
| Safety and tolerability: incidence of treatment-emergent adverse events | Through trial completion, an average of 3 weeks | Incidence of adverse events reported in the study and coded by MedDRA. |
Countries
United States
Contacts
CONTACTGH Research Limited Clinical Trial Enquiries
Outcome results
None listed