Pharmacokinetics of GH001 in Healthy Volunteers

GH Research

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: 5 Methoxy N,N Dimethyltryptamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05163691

2021-000241-40 (EudraCT Number)

GH001-HV-103

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 5 patient groups

Group A - 6 mg single-dose

Experimental group

Description:

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

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Drug: Placebo

Group B - 12 mg single-dose

Experimental group

Description:

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

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Drug: Placebo

Group C - 18 mg single-dose

Experimental group

Description:

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

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Drug: Placebo

Group D - Individualized Dosing Regimen, 1-hour interval

Experimental group

Description:

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)

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine

Group E - Individualized Dosing Regimen, 2-hour interval

Experimental group

Description:

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)

Treatment:

Drug: 5 Methoxy N,N Dimethyltryptamine