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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000241-40 | EudraCT Number |
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The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001. As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - 6 mg single-dose | Experimental | A single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects) |
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| Group B - 12 mg single-dose | Experimental | A single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects) |
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| Group C - 18 mg single-dose | Experimental | A single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects) |
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| Group D - Individualized Dosing Regimen, 1-hour interval | Experimental | Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 1-hour dose interval (8 subjects) |
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| Group E - Individualized Dosing Regimen, 2-hour interval | Experimental | Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 2-hour dose interval (8 subjects) |
| 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 |
|---|---|---|
| The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine | For PK analyses, blood samples will be collected before and up to 4 hours after the administration of GH001 to determine 5-MeO-DMT and bufotenine serum concentrations. | up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Event (AE) reporting | Adverse events reported in the study and coded by MedDRA. | Up to 30 days |
| Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GH Research Clinical Team | GH Research Ireland Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GH Research Clinical Trial Site | Groningen | Netherlands |
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| Label | URL |
|---|---|
| GH Research Company Website | View source |
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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.
Single-dose Part:
A double-blind, placebo-controlled, randomized, parallel-group design with single, inhaled doses of GH001 in 3 groups of 10 subjects (randomized as 8 active and 2 placebo subjects per group):
Multiple-Dose Part:
An open-label, non-randomized administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with two different dose intervals (8 subjects per group):
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| Placebo | Drug | GH001 Placebo administered via inhalation |
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Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator
| Up to 7 days |
| Safety: Frequency of clinically significant changes from baseline in vital signs measurement | Vital signs include heart rate (beats per minute), blood pressure (mmHg), respiratory rate (breaths per minute), oxygen saturation (%), and temperature (degrees celsius). Changes are defined as any clinically significant change from baseline as determined by the principal investigator | Up to 7 days |
| Safety: Frequency of clinically significant changes from baseline in safety laboratory tests of blood and urine | Safety laboratory analyses are analyses of blood samples (biochemistry, hematology) and urine samples (urinalysis). Changes are defined as any clinically significant change from baseline as determined by the principal investigator. | Up to 7 days |
| Safety: Frequency of clinically significant changes from baseline in Peak Flow Respirometry | Peak Flow is assessed using a standard peak flow respirometer, with the assessment done three times and the best of the three scores recorded as the final score (liters/minute). | 1 hour after dosing |
| Safety: Frequency of clinically significant changes from baseline in level of sedation | The Modified Observer's Assessment of Alertness and Sedation scale (MOAA/S) will be completed before and after GH001 dosing. Scored from 0 (deep sedation) to 5 (alert) | 30 minutes and 1 hour after dosing |
| Safety: Change from baseline in Clinician Administered Dissociative States Scale (CADSS) | Change from baseline in the 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. | Up to 30 days |
| Safety: Assessment of Subject-Discharge readiness | Assessment of Discharge Readiness on the administration day by the Principal Investigator, using the Clinical Global Assessment of Discharge Readiness (CGADR). | up to 3 hours after last study drug administration |
| Mental Health: Change from baseline in Brief Psychiatric Rating Scale (BPRS) | Change from baseline in the 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. | Up to 30 days |
| Mental Health: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | Change from baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS). A detailed questionnaire assessing both suicidal behaviour and suicidal ideation. No combined score is created. | Up to 30 days |
| Pharmacodynamic assessment: The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale | The Peak Experience Scale (PES) is a Visual Analogue Scale scored from 0-100 | up to 1 hour after dosing |
| Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30) | The MEQ30 is a validated procedure for assessing the extent of the psychoactive effects experienced by a subject. The validated MEQ30 uses thirty assessment questions across four areas of experience, all scored from 0 to 5. | up to 1 hour after dosing |
| Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ) | Completed by the subject after GH001 administration and assesses seven factors (grief, fear, death, insanity, isolation, physical distress, and paranoia) all scored from 0 to 5. | up to 1 hour after dosing |
| Pharmacodynamic assessment: Duration of the psychoactive effects (PsE) | The duration of the experience, defined as time in minutes from drug administration to time when the subject reports that any psychoactive symptoms have subsided will be recorded. | up to 1 hour after dosing |
| Cognitive Function: Change from baseline in Psychomotor Vigilance Task (PVT) | Change from baseline in the Psychomotor Vigilance Test (PVT). A computerized test assessing the reaction time in response to a visual stimulus. Outcome measures are Response Time and the number of attentional lapses (Response Time ≥ 500 msec). | Up to 7 days |
| Cognitive Function: Change from baseline in Auditory Verbal Learning Test (AVLT) | The AVLT is one of the most widely used word learning tests in clinical research and practice. The test is based on successive auditory presentations of 15-word lists followed by attempted recall. The AVLT outcome measures are the rate of learning as well as the level of recall. | Up to 7 days |
| Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task | The SWM task requires retention and manipulation of visuo-spatial information. This self-ordered test provides a measure of strategy as well as working memory errors. The test involves a number of colored squares (boxes) shown on the screen which require a selection strategy to fill an empty column. The test takes about 4 minutes to complete. Outcome measures of the SWM include errors and strategy. The computerized Corsi Block will be the version of the SWM task used in this study. | Up to 7 days |
| Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST) | Change from baseline in the Digit Symbol Substitution Test (DSST). A computerized test with the task is to match digits with symbols from encoding list. The number of digits correctly encoded within 3 minutes is the performance measure. | 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 |