Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects
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, GH001 Aerosol Delivery System.
- Who it may be relevant to
- Registry conditions: Healthy Adult. Basic parameters: 21 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 States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System 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.
Interventions
- Drug 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation - Device GH001 Aerosol Delivery System
GH001 aerosol delivery system
Primary outcome measures
- Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - terminal elimination rate constant (λz) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - apparent total body clearance (CL/F) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F) [Time frame: Day 1]
- Serum PK parameters of mebufotenin - Cmax/AUCinf [Time frame: Day 1]
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 90 days 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
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- GH Research Clinical Trial Site — Miami
Identifiers
NCT: NCT07540494 · GH001-HV-109