A Phase 1 interventional study of 5 Methoxy N,N Dimethyltryptamine and Placebo in Healthy Volunteers, sponsored by GH Research Ireland Limited. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-20.
Sponsored by GH Research Ireland Limited · Phase 1, Interventional, and Treatment
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.
GH Research Ireland Limited is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects)
Drug: 5 Methoxy N,N Dimethyltryptamine · Drug: Placebo
A single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects)
Drug: 5 Methoxy N,N Dimethyltryptamine · Drug: Placebo
A single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects)
Drug: 5 Methoxy N,N Dimethyltryptamine · Drug: Placebo
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)
Drug: 5 Methoxy N,N Dimethyltryptamine
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)
Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Also known as: GH001, 5-MeO-DMT
GH001 Placebo administered via inhalation
Also known as: GH001 Placebo
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.
Time frame: up to 4 hours
Safety: Adverse Event (AE) reporting
Adverse events reported in the study and coded by MedDRA.
Time frame: Up to 30 days
Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording
Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 days
Plan to share: No
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GH Research Ireland Limited