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Pharmacokinetics of GH001 in Healthy Volunteers

NCT ID: NCT05163691

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2021-11-22

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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5-MeO-DMT 5-methoxy-N,N-dimethyltryptamine 5-methoxy-dimethyltryptamine Healthy Volunteers Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will include separate single- and multiple-dose parts.

Single-dose Part:

A double-blind, placebo-controlled, randomized, parallel-group design with single, inhaled doses of GH001 in 3 groups of 10 subjects (randomized as 8 active and 2 placebo subjects per group):

* Group A: single inhaled dose of 6 mg GH001
* Group B: single inhaled dose of 12 mg GH001
* Group C: single inhaled dose of 18 mg GH001

Multiple-Dose Part:

An open-label, non-randomized administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with two different dose intervals (8 subjects per group):

* Group D: 1-hour interval
* Group E: 2-hour interval
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A - 6 mg single-dose

A single, inhaled dose of GH001 6 mg or placebo (randomized as 8 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH001 administered via inhalation

Placebo

Intervention Type DRUG

GH001 Placebo administered via inhalation

Group B - 12 mg single-dose

A single, inhaled dose of GH001 12 mg or placebo (randomized as 8 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH001 administered via inhalation

Placebo

Intervention Type DRUG

GH001 Placebo administered via inhalation

Group C - 18 mg single-dose

A single, inhaled dose of GH001 18 mg or placebo (randomized as 8 active and 2 placebo subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH001 administered via inhalation

Placebo

Intervention Type DRUG

GH001 Placebo administered via inhalation

Group D - Individualized Dosing Regimen, 1-hour interval

Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 1-hour dose interval (8 subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH001 administered via inhalation

Group E - Individualized Dosing Regimen, 2-hour interval

Administration of up to 3 inhaled doses of GH001 within a single day (6 mg, followed by 12 mg, followed by 18 mg) with a 2-hour dose interval (8 subjects)

Group Type EXPERIMENTAL

5 Methoxy N,N Dimethyltryptamine

Intervention Type DRUG

GH001 administered via inhalation

Interventions

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5 Methoxy N,N Dimethyltryptamine

GH001 administered via inhalation

Intervention Type DRUG

Placebo

GH001 Placebo administered via inhalation

Intervention Type DRUG

Other Intervention Names

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GH001 5-MeO-DMT GH001 Placebo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GH Research Ireland Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GH Research Clinical Team

Role: STUDY_DIRECTOR

GH Research Ireland Limited

Locations

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GH Research Clinical Trial Site

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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http://www.ghres.com

GH Research Company Website

Other Identifiers

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2021-000241-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GH001-HV-103

Identifier Type: -

Identifier Source: org_study_id