CompletedPhase 1

Pharmacokinetics of GH001 in Healthy Volunteers

NCT05163691 · GH Research Ireland Limited

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine
Measured over up to 4 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: * Subject has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive); * Subject is in good physical health in the opinion of the principal investigator (PI); * Subject is in good mental health in the opinion of the PI and clinical psychologist; Exclusion Criteria: * Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT; * Has received any investigational medication within the last 4 weeks; * Has a medical condition, which renders the subject unsuitable for the study.

Where

1 study site

Facility	City	Region	Country
GH Research Clinical Trial Site	Groningen	—	Netherlands

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05163691 on ClinicalTrials.gov →

Last updated in the registry 2021-12-20. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

All 9 trials from GH Research Ireland Limited →