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Pharmacokinetics of GH001 in Healthy Volunteers

NCT05163691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-12-20

No results posted yet for this study

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

DRUG

5 Methoxy N,N Dimethyltryptamine

GH001 administered via inhalation

DRUG

Placebo

GH001 Placebo administered via inhalation

Sponsors & Collaborators

  • GH Research Ireland Limited

    lead INDUSTRY

Principal Investigators

  • GH Research Clinical Team · GH Research Ireland Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2021-10-23
Completion
2021-11-22

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05163691 on ClinicalTrials.gov