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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GH001 | Experimental | A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 Methoxy N,N Dimethyltryptamine | Drug | GH001 administered via inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax) | 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 |
| Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2) | 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 |
| Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast) | 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 |
| Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf) | 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 |
| Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2) | For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GH Research Limited Clinical Trial Enquiries | Contact | +353874503237 | clinicaltrials@ghres.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GH Research Clinical Trial Site | Miami | Florida | 33319 | United States |
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| ID | Term |
|---|---|
| D008732 | Methoxydimethyltryptamines |
| ID | Term |
|---|---|
| D004130 | N,N-Dimethyltryptamine |
| D014363 | Tryptamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
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| GH001 Aerosol Delivery System | Device | GH001 aerosol delivery system |
|
| Day 1 |
| Serum PK parameters of mebufotenin - terminal elimination rate constant (λz) | 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 |
| Serum PK parameters of mebufotenin - apparent total body clearance (CL/F) | 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 |
| Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F) | 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 |
| Serum PK parameters of mebufotenin - Cmax/AUCinf | 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 |
| 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 |
| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D002027 | Bufotenin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012701 | Serotonin |