Actively Recruiting
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Led by GH Research Ireland Limited · Updated on 2024-08-07
52
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Known allergies or hypersensitivity to mebufotenin, bufotenin, melatonin, or triptans
- Received any investigational medication or vaccine within 3 months prior to baseline or currently in follow-up for another trial
- Current or past clinically significant condition making participation unsuitable per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GH Research Clinical Trial Site
London, United Kingdom
Actively Recruiting
Research Team
G
GH Research Limited Clinical Trial Enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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