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| ID | Type | Description | Link |
|---|---|---|---|
| IRAS Number | Other Identifier | 1009720 |
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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 and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Cohort A | Experimental | A single dose inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
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| Part 1, Cohort B | Experimental | A single dose inhaled dose of 12 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
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| Part 1, Cohort C | Experimental | A single dose inhaled dose of 18 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
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| Part 1, Cohort D (optional) | Experimental | 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). |
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| Part 1, Cohort E (optional) | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 Methoxy N,N Dimethyltryptamine | Drug | GH001 administered via inhalation |
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| 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. | Up to 6 hours |
| 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. | Up to 6 hours |
| 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. | Up to 6 hours |
| Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) | 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 |
| Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUC0-∞) | 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GH Research Limited Clinical Trial Enquiries | Contact | +353 87 450 3237 | clinicaltrials@ghres.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GH Research Clinical Trial Site | Recruiting | London | United Kingdom |
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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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This study will include separate single- and multiple-dose parts.
Part 1 (Single-Dose Part):
An 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.
Part 2 (Multiple-Dose Part):
An 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).
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| Part 2, Cohort F | Experimental | 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. |
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| Up to 6 hours |
| 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. | Up to 6 hours |
| Serum PK parameters of mebufotenin - apparent steady-state volume of distribution (VSS/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. | Up to 6 hours |
| Serum PK parameters of mebufotenin - Cmax/AUC0-∞ | 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 |
| Safety and tolerability: incidence of treatment-emergent adverse events | Adverse events reported in the study and coded by MedDRA. | Up to 7 days |
| 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). Percentage 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). Percentage of subjects with clinically significant changes* from baseline in spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]). Percentage of subjects with clinically significant changes* from baseline in safety laboratory assessments (hematology, biochemistry, and urinalysis). *Clinically significant changes as determined by the principal investigator | Up to 7 days |
| Safety and tolerability: assessment of sedation (Modified Observer's Assessment of Alertness and Sedation [MOAA/S]) following each dose and as part of the discharge evaluation on Day 0 | The MOAA/S 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) |
| 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 |
| 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) |
| Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization. | A detailed questionnaire assessing both suicidal behaviour and suicidal ideation. | Up to 7 days |
| 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. | From baseline up to 7 days |
| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D002027 | Bufotenin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012701 | Serotonin |