Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Recruiting now · Phase 1
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT06511947
- Run by
- GH Research Ireland Limited
- People needed
- 52
- Starts
- 2024-08-01
- Expected to finish
- 2025-02-01
- Last updated by the study team
- 2024-08-07
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 may not qualify if…
- 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.
Where it is running
- GH Research Clinical Trial Site — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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