NCT05163691

Pharmacokinetics of GH001 in Healthy Volunteers

A Phase 1 Study to Determine the Pharmacokinetics and Pharmacodynamics of Single and Multiple Inhaled Doses of GH001 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: GH Research Ireland Limited · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	5 Methoxy N,N Dimethyltryptamine	GH001 administered via inhalation
DRUG	Placebo	GH001 Placebo administered via inhalation

Timeline

• Start date: 2021-06-21
• Primary completion: 2021-10-23
• Completion: 2021-11-22
• First posted: 2021-12-20
• Last updated: 2021-12-20

Locations

1 site across 1 country: Netherlands