The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001.
As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.
Topic Healthy Subjects
Country Ireland
Visit trial
Status
Completed
Results Published
Start date
21 June 2021
End date
22 November 2021
Chance of happening
100%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
Second
Participants
46
Sex
All
Age
18- 64
Therapy
No
Trial Details
The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001. As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.NCT Number NCT05163691
Sponsors & Collaborators
GH ResearchGH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.