Healthy VolunteersPhase 1NCT06511947
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
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 United Kingdom.
Trial summary
This is an open-label Phase 1 trial in healthy subjects designed to characterize the pharmacokinetic (PK) profile, pharmacodynamics, and safety and tolerability of GH001 (mebufotenin) delivered via the GH001 Aerosol Delivery System (ADS). The trial is conducted in three parts. 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?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2024to 23 Mar 2026
- 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
- Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening
- Good mental health in the opinion of the investigator.
- Normal spirometry (FEV1 of >80% of predicted and FVC of >80% of predicted value) at screening.
Who cannot join
- Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.
- Has received any investigational medication, including investigational vaccines, in the 3 months prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.
- Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
This is an open-label Phase 1 trial in healthy subjects designed to characterize the pharmacokinetic (PK) profile, pharmacodynamics, and safety and tolerability of GH001 (mebufotenin) delivered via the GH001 Aerosol Delivery System (ADS).
The trial is conducted in three parts. In Part 1, subjects receive a single dose of GH001 via the ADS. In Part 2, subjects receive GH001 via both the ADS and the Volcano Medic 2 Vaporization System in a crossover design, to estimate the relative bioavailability of mebufotenin between the two delivery systems. In Part 3, subjects receive a single-day individualized dosing regimen (IDR) of GH001 via the ADS, in which up to three increasing doses are given at approximately 1-hour intervals.
Read more
The primary objectives are to determine the serum PK profile of mebufotenin and its metabolites and to evaluate the safety and tolerability of GH001 across these parts. Secondary objectives include characterizing the pharmacodynamic profile, as assessed by its psychoactive effects (PsE) and effects on cognitive performance, and estimating the time for the maximum serum concentration (Cmax) to decline by 50% and 90% (tCmax/2 and tCmax/10).
Part 3 of this trial was not initiated. The trial was terminated after Part 2.
- Conditions
- Healthy Volunteers
- Being tested
- 5 Methoxy N,N Dimethyltryptamine
- Keywords
- Mebufotenin, 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, GH001, 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 Mebufotenin, 5-MeO-DMT, GH001
GH001 administered via inhalation
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Cohort A | Experimental | A single inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 1, Cohort B | Experimental | A single inhaled dose of 12 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 1, Cohort C | Experimental | A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in eight subjects. Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 1, Cohort D (optional) | Experimental | A single inhaled intermediate dose of 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). Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 1, Cohort E (optional) | Experimental | A single inhaled intermediate dose of 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). Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 1, Cohort F (optional) | Experimental | A single inhaled intermediate dose of 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 D and E). Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 1, Cohort G (optional) | Experimental | A single inhaled intermediate dose of 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 D and E). Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 2, Cohort H | Experimental | A single-sequence crossover cohort of 12 subjects. Each subject receives a single inhaled dose of 6 mg GH001 administered via the Volcano Medic 2 Vaporization System in Treatment Period 1, followed by a single inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in Treatment Period 2, with 14 days between the dosing day of each treatment period. Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 2, Cohort I | Experimental | A randomized, two-sequence crossover cohort of up to 16 subjects. Each subject is randomly assigned to a device administration sequence and receives a single inhaled dose of 6 mg GH001 via the Volcano Medic 2 Vaporization System and a single inhaled dose of GH001 via a proprietary aerosol delivery device across two treatment periods, with 14 days between the dosing day of each treatment period. The dose administered via the proprietary aerosol delivery device is determined by the study safety group (SSG) to achieve systemic exposure comparable to 6 mg GH001 administered via the Volcano Medic 2 Vaporization System. Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 3, Cohort J | Experimental | An individualized dosing regimen (IDR) of GH001 administered via a proprietary aerosol delivery device on a single day in 12 subjects. Up to three escalating doses are administered at approximately 1-hour intervals. The second and third doses are administered only if a peak experience was not achieved after the previous dose, the previous dose was satisfactorily tolerated, any psychoactive effects of the previous dose have substantially subsided, and vital signs and FEV1 are acceptable. This cohort was not initiated. The trial was terminated after Part 2. Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
| Part 3, Cohort K (optional) | Experimental | An optional individualized dosing regimen (IDR) cohort of 12 subjects, identical in design to Cohort J, administered via a proprietary aerosol delivery device. Enrolled only if safety, PK, and PD data from Cohort J indicate further exploration is needed (dependent on study safety group [SSG] review). This cohort was not initiated. The trial was terminated after Part 2. Receives: Drug: 5 Methoxy N,N Dimethyltryptamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 6 hours
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.
Measured: Up to 6 hours
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.
Measured: Up to 6 hours
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.
Measured: 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.
Measured: 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.
Measured: Up to 6 hours
Serum PK parameters of mebufotenin - apparent volume of distribution (up to bioavailability) after 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.
Measured: Up to 6 hours
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.
Measured: Up to 6 hours
Safety and tolerability: incidence of treatment-emergent adverse events
Adverse events reported in the study and coded by MedDRA.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From baseline up to 7 days
Estimate of the relative bioavailability for Cmax, AUClast, AUCinf, and AUCt1-t2 of mebufotenin
Estimate of the relative bioavailability between the GH001 ADS and Volcano Medic 2 Vaporization System for Cmax, AUClast, AUCinf, and AUCt1-t2 of mebufotenin
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Aug 2024
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Why it stopped: The Sponsor elected to stop the trial after Part 1 and 2, having determined the scientific objective was met with sufficient data to select doses for future trials. Not driven by safety, tolerability, or recruitment; all subjects completed the trial.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This trial includes single- and multiple-dose parts conducted across three parts. Part 1 (Single-Dose): An open-label, non-randomized, parallel-design part in which subjects receive a single dose of GH001 via the GH001 Aerosol Delivery System (ADS), in sequential cohorts. Part 2 (Crossover): An open-label part in which subjects receive two single doses of GH001, administered via both the ADS and the Volcano Medic 2 Vaporization System on separate days, to estimate relative bioavailability. One cohort follows a single-sequence crossover design and one follows a randomized, two-sequence crossover design. Part 3 (Multiple-Dose): An open-label, non-randomized part in which up to three escalating doses of GH001 are administered via the ADS on a single day (individualized dosing regimen).
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- GH Research Ireland Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511947
- Sponsor's protocol ID
- GH001-HV-106-2
- Other IDs
- IRAS Number
- Status last verified
- Oct 2026
- First submitted
- 28 Jun 2024
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06511947
- Acronym / sponsor ID
- GH001-HV-106-2
- Conditions
- Healthy Volunteers
- Keywords
- Mebufotenin, 5-MeO-DMT, 5-methoxy-N,N-dimethyltryptamine, GH001, Healthy volunteers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor elected to stop the trial after Part 1 and 2, having determined the scientific objective was met with sufficient data to select doses for future trials. Not driven by safety, tolerability, or recruitment; all subjects completed the trial.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- GH Research Ireland LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 22 Jul 2024 (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.
This is an open-label Phase 1 trial in healthy subjects designed to characterize the pharmacokinetic (PK) profile, pharmacodynamics, and safety and tolerability of GH001 (mebufotenin) delivered via the GH001 Aerosol Delivery System (ADS).
The trial is conducted in three parts. In Part 1, subjects receive a single dose of GH001 via the ADS. In Part 2, subjects receive GH001 via both the ADS and the Volcano Medic 2 Vaporization System in a crossover design, to estimate the relative bioavailability of mebufotenin between the two delivery systems. In Part 3, subjects receive a single-day individualized dosing regimen (IDR) of GH001 via the ADS, in which up to three increasing doses are given at approximately 1-hour intervals.
The primary objectives are to determine the serum PK profile of mebufotenin and its metabolites and to evaluate the safety and tolerability of GH001 across these parts. Secondary objectives include characterizing the pharmacodynamic profile, as assessed by its psychoactive effects (PsE) and effects on cognitive performance, and estimating the time for the maximum serum concentration (Cmax) to decline by 50% and 90% (tCmax/2 and tCmax/10).
Part 3 of this trial was not initiated. The trial was terminated after Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
- Model description
- This trial includes single- and multiple-dose parts conducted across three parts. Part 1 (Single-Dose): An open-label, non-randomized, parallel-design part in which subjects receive a single dose of GH001 via the GH001 Aerosol Delivery System (ADS), in sequential cohorts. Part 2 (Crossover): An open-label part in which subjects receive two single doses of GH001, administered via both the ADS and the Volcano Medic 2 Vaporization System on separate days, to estimate relative bioavailability. One cohort follows a single-sequence crossover design and one follows a randomized, two-sequence crossover design. Part 3 (Multiple-Dose): An open-label, non-randomized part in which up to three escalating doses of GH001 are administered via the ADS on a single day (individualized dosing regimen).
| Arm | Type | Receives |
|---|---|---|
| Part 1, Cohort A | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
| Part 1, Cohort B | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single inhaled dose of 12 mg GH001 administered via a proprietary aerosol delivery device in eight subjects. |
| Part 1, Cohort C | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single inhaled dose of GH001 administered via a proprietary aerosol delivery device in eight subjects. |
| Part 1, Cohort D (optional) | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single inhaled intermediate dose of 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). |
| Part 1, Cohort E (optional) | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single inhaled intermediate dose of 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). |
| Part 1, Cohort F (optional) | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single inhaled intermediate dose of 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 D and E). |
| Part 1, Cohort G (optional) | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single inhaled intermediate dose of 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 D and E). |
| Part 2, Cohort H | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA single-sequence crossover cohort of 12 subjects. Each subject receives a single inhaled dose of 6 mg GH001 administered via the Volcano Medic 2 Vaporization System in Treatment Period 1, followed by a single inhaled dose of 6 mg GH001 administered via a proprietary aerosol delivery device in Treatment Period 2, with 14 days between the dosing day of each treatment period. |
| Part 2, Cohort I | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineA randomized, two-sequence crossover cohort of up to 16 subjects. Each subject is randomly assigned to a device administration sequence and receives a single inhaled dose of 6 mg GH001 via the Volcano Medic 2 Vaporization System and a single inhaled dose of GH001 via a proprietary aerosol delivery device across two treatment periods, with 14 days between the dosing day of each treatment period. The dose administered via the proprietary aerosol delivery device is determined by the study safety group (SSG) to achieve systemic exposure comparable to 6 mg GH001 administered via the Volcano Medic 2 Vaporization System. |
| Part 3, Cohort J | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineAn individualized dosing regimen (IDR) of GH001 administered via a proprietary aerosol delivery device on a single day in 12 subjects. Up to three escalating doses are administered at approximately 1-hour intervals. The second and third doses are administered only if a peak experience was not achieved after the previous dose, the previous dose was satisfactorily tolerated, any psychoactive effects of the previous dose have substantially subsided, and vital signs and FEV1 are acceptable. This cohort was not initiated. The trial was terminated after Part 2. |
| Part 3, Cohort K (optional) | Experimental | Drug: 5 Methoxy N,N DimethyltryptamineAn optional individualized dosing regimen (IDR) cohort of 12 subjects, identical in design to Cohort J, administered via a proprietary aerosol delivery device. Enrolled only if safety, PK, and PD data from Cohort J indicate further exploration is needed (dependent on study safety group [SSG] review). This cohort was not initiated. The trial was terminated after Part 2. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) in the range of 18.5 to 35 kg/m2 (inclusive) at screening
- Good mental health in the opinion of the investigator.
- Normal spirometry (FEV1 of >80% of predicted and FVC of >80% of predicted value) at screening.
Key exclusion criteria (3 listed)
- Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.
- Has received any investigational medication, including investigational vaccines, in the 3 months prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.
- Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.
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: Mebufotenin, 5-MeO-DMT, GH001GH001 administered via inhalation | Drug | Part 1, Cohort A, Part 1, Cohort B, Part 1, Cohort C, Part 1, Cohort D (optional), Part 1, Cohort E (optional), Part 1, Cohort F (optional), Part 1, Cohort G (optional), Part 2, Cohort H, Part 2, Cohort I, Part 3, Cohort J, Part 3, Cohort K (optional) |
Primary outcome
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - partial area under the curve between t1 and t2 (AUCt1-t2)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - apparent volume of distribution (up to bioavailability) after extravascular administration (Vz/F)
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Serum PK parameters of mebufotenin - Cmax/AUCinf
Time frame: Up to 6 hours
For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
Safety and tolerability: incidence of treatment-emergent adverse events
Time frame: Up to 7 days
Adverse events reported in the study and coded by MedDRA.
Safety and tolerability: clinically significant changes from baseline in electrocardiogram (ECG), vital signs, spirometry and safety laboratory assessments
Time frame: Up to 7 days
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
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
Time frame: Postdose, up to discharge on dosing day (Day 0)
The MOAA/S will be completed before and after GH001 dosing. Scored from 0 (deep sedation) to 5 (alert).
Safety and tolerability: change from baseline in Clinician Administered Dissociative States Scale (CADSS)
Time frame: From baseline up to 7 days
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.
Safety and tolerability: assessment of subject discharge readiness at discharge on Day 0
Time frame: Postdose, at discharge on dosing day (Day 0)
Assessment of Discharge Readiness on the administration day by the principal investigator, using the Clinical Assessment of Discharge Readiness (CADR).
Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization.
Time frame: Up to 7 days
A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.
Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
Time frame: From baseline up to 7 days
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.
Estimate of the relative bioavailability for Cmax, AUClast, AUCinf, and AUCt1-t2 of mebufotenin
Time frame: Up to 6 hours
Estimate of the relative bioavailability between the GH001 ADS and Volcano Medic 2 Vaporization System for Cmax, AUClast, AUCinf, and AUCt1-t2 of mebufotenin
Results and safety
The study was stopped early (reason given: The Sponsor elected to stop the trial after Part 1 and 2, having determined the scientific objective was met with sufficient data to select doses for future trials. Not driven by safety, tolerability, or recruitment; all subjects completed the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 United Kingdom.
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: stopped early, as of the sponsor's last update on 9 Oct 2026. 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 United Kingdom. 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 was stopped early (reason given: The Sponsor elected to stop the trial after Part 1 and 2, having determined the scientific objective was met with sufficient data to select doses for future trials. Not driven by safety, tolerability, or recruitment; all subjects completed the trial.). Results are not available in the source record.
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?
Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) (time frame: Up to 6 hours). The study lists 18 primary outcomes in all. 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 9 Oct 2026.