Healthy VolunteersPhase 1NCT05163691
Pharmacokinetics of GH001 in Healthy Volunteers
A Phase 1 study testing 5 Methoxy N,N Dimethyltryptamine in people with Healthy Volunteers, run by GH Research Ireland Limited at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 5 Methoxy N,N Dimethyltryptamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jun 2021to 22 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
- Subject is in good physical health in the opinion of the principal investigator (PI);
- Subject is in good mental health in the opinion of the PI and clinical psychologist;
Who cannot join
- Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
- Has received any investigational medication within the last 4 weeks;
- Has a medical condition, which renders the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Determine the Pharmacokinetics and Pharmacodynamics of Single and Multiple Inhaled Doses of GH001 in Healthy Volunteers
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.
- Conditions
- Healthy Volunteers
- Being tested
- 5 Methoxy N,N Dimethyltryptamine, Placebo
- Keywords
- 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, 5-methoxy-dimethyltryptamine, Healthy Volunteers, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 Methoxy N,N DimethyltryptamineDrug
Also called GH001, 5-MeO-DMT
GH001 administered via inhalation
PlaceboDrug
Also called GH001 Placebo
GH001 Placebo administered via inhalation
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| 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) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| 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) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine; Drug: Placebo |
| 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) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| 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) Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 hours
Secondary outcomes (18)
Safety: Adverse Event (AE) reporting
Adverse events reported in the study and coded by MedDRA.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start21 Jun 2021
- Primary completion23 Oct 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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): * Group A: single inhaled dose of 6 mg GH001 * Group B: single inhaled dose of 12 mg GH001 * Group C: single inhaled dose of 18 mg GH001 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): * Group D: 1-hour interval * Group E: 2-hour interval
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GH Research Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GH Research Clinical Team, Study director, GH Research Ireland Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163691
- Sponsor's protocol ID
- GH001-HV-103
- Other IDs
- 2021-000241-40
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Determine the Pharmacokinetics and Pharmacodynamics of Single and Multiple Inhaled Doses of GH001 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05163691
- Acronym / sponsor ID
- GH001-HV-103
- Conditions
- Healthy Volunteers
- Keywords
- 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, 5-methoxy-dimethyltryptamine, Healthy Volunteers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GH Research Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 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): * Group A: single inhaled dose of 6 mg GH001 * Group B: single inhaled dose of 12 mg GH001 * Group C: single inhaled dose of 18 mg GH001 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): * Group D: 1-hour interval * Group E: 2-hour interval
| Arm | Type | Receives |
|---|---|---|
| Group A - 6 mg single-dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects) |
| Group B - 12 mg single-dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects) |
| Group C - 18 mg single-dose | Experimental | Drug: 5 Methoxy N,N Dimethyltryptamine, Drug: PlaceboA single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects) |
| Group D - Individualized Dosing Regimen, 1-hour interval | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineAdministration 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) |
| Group E - Individualized Dosing Regimen, 2-hour interval | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineAdministration 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) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
- Subject is in good physical health in the opinion of the principal investigator (PI);
- Subject is in good mental health in the opinion of the PI and clinical psychologist;
Key exclusion criteria (3 listed)
- Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
- Has received any investigational medication within the last 4 weeks;
- Has a medical condition, which renders the subject unsuitable for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 Methoxy N,N DimethyltryptamineAlso: GH001, 5-MeO-DMTGH001 administered via inhalation | Drug | Group A - 6 mg single-dose, Group B - 12 mg single-dose, Group C - 18 mg single-dose, Group D - Individualized Dosing Regimen, 1-hour interval, Group E - Individualized Dosing Regimen, 2-hour interval |
| PlaceboAlso: GH001 PlaceboGH001 Placebo administered via inhalation | Drug | Group A - 6 mg single-dose, Group B - 12 mg single-dose, Group C - 18 mg single-dose |
Primary outcome
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine
Time frame: up to 4 hours
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.
18 secondary outcomes
Safety: Adverse Event (AE) reporting
Time frame: Up to 30 days
Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording
Time frame: Up to 7 days
Safety: Frequency of clinically significant changes from baseline in vital signs measurement
Time frame: Up to 7 days
Safety: Frequency of clinically significant changes from baseline in safety laboratory tests of blood and urine
Time frame: Up to 7 days
Safety: Frequency of clinically significant changes from baseline in Peak Flow Respirometry
Time frame: 1 hour after dosing
Safety: Frequency of clinically significant changes from baseline in level of sedation
Time frame: 30 minutes and 1 hour after dosing
Safety: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Time frame: Up to 30 days
Safety: Assessment of Subject-Discharge readiness
Time frame: up to 3 hours after last study drug administration
Mental Health: Change from baseline in Brief Psychiatric Rating Scale (BPRS)
Time frame: Up to 30 days
Mental Health: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 30 days
Pharmacodynamic assessment: The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale
Time frame: up to 1 hour after dosing
Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)
Time frame: up to 1 hour after dosing
Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)
Time frame: up to 1 hour after dosing
Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)
Time frame: up to 1 hour after dosing
Cognitive Function: Change from baseline in Psychomotor Vigilance Task (PVT)
Time frame: Up to 7 days
Cognitive Function: Change from baseline in Auditory Verbal Learning Test (AVLT)
Time frame: Up to 7 days
Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task
Time frame: Up to 7 days
Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)
Time frame: Up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- GH Research Company WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GH Research Clinical Team study director
GH Research Ireland Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5 Methoxy N,N Dimethyltryptamine in people with Healthy Volunteers, run by GH Research Ireland Limited at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.