Menu
Recruiting NCT06511947

Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 5 Methoxy N,N Dimethyltryptamine.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug 5 Methoxy N,N Dimethyltryptamine
    GH001 administered via inhalation

Primary outcome measures

  • Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUC0-∞) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - terminal elimination rate constant (λz) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - apparent total body clearance (CL/F) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - apparent steady-state volume of distribution (VSS/F) [Time frame: Up to 6 hours]
  • Serum PK parameters of mebufotenin - Cmax/AUC0-∞ [Time frame: Up to 6 hours]
  • Safety and tolerability: incidence of treatment-emergent adverse events [Time frame: Up to 7 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • GH Research Clinical Trial Site — London

Identifiers

NCT: NCT06511947 · GH001-HV-106-2 · IRAS Number

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗