Clinical trial NCT06511947: Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Mebufotenin
5-MeO-DMT
5-methoxy-N,N-dimethyltryptamine
GH001
Healthy volunteers
Pharmacokinetics
Lead sponsor: GH Research Ireland Limited
Sponsor class: INDUSTRY
First posted: 2024-07-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Serum PK parameters of mebufotenin - maximum observed concentration (Cmax)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUC0-∞)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - terminal elimination rate constant (λz)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - apparent total body clearance (CL/F)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - apparent steady-state volume of distribution (VSS/F)
timeFrame: Up to 6 hours
measure: Serum PK parameters of mebufotenin - Cmax/AUC0-∞
timeFrame: Up to 6 hours
measure: Safety and tolerability: incidence of treatment-emergent adverse events
timeFrame: Up to 7 days
measure: Safety and tolerability: clinically significant changes from baseline in electrocardiogram (ECG), vital signs, spirometry and safety laboratory assessments
timeFrame: Up to 7 days
measure: 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
timeFrame: Postdose, up to discharge on dosing day (Day 0)
measure: Safety and tolerability: change from baseline in Clinician Administered Dissociative States Scale (CADSS)
timeFrame: From baseline up to 7 days
measure: Safety and tolerability: assessment of subject discharge readiness at discharge on Day 0
timeFrame: Postdose, at discharge on dosing day (Day 0)
measure: Safety and tolerability: Columbia-Suicide Severity Rating Scale (C-SSRS) categorization.
timeFrame: Up to 7 days
measure: Safety and tolerability: Change from baseline in Brief Psychiatric Rating Scale (BPRS).
timeFrame: From baseline up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GH Research Clinical Trial Site
Study officials:
References: