Clinical trial NCT05163691: Pharmacokinetics of GH001 in Healthy Volunteers
Official title: A Phase 1 Study to Determine the Pharmacokinetics and Pharmacodynamics of Single and Multiple Inhaled Doses of GH001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: 5-MeO-DMT
5-methoxy-N,N-dimethyltryptamine
5-methoxy-dimethyltryptamine
Healthy Volunteers
Pharmacokinetics
Lead sponsor: GH Research Ireland Limited
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine
timeFrame: up to 4 hours
Secondary outcomes:
measure: Safety: Adverse Event (AE) reporting
timeFrame: Up to 30 days
measure: Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording
timeFrame: Up to 7 days
measure: Safety: Frequency of clinically significant changes from baseline in vital signs measurement
timeFrame: Up to 7 days
measure: Safety: Frequency of clinically significant changes from baseline in safety laboratory tests of blood and urine
timeFrame: Up to 7 days
measure: Safety: Frequency of clinically significant changes from baseline in Peak Flow Respirometry
timeFrame: 1 hour after dosing
measure: Safety: Frequency of clinically significant changes from baseline in level of sedation
timeFrame: 30 minutes and 1 hour after dosing
measure: Safety: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)
timeFrame: Up to 30 days
measure: Safety: Assessment of Subject-Discharge readiness
timeFrame: up to 3 hours after last study drug administration
measure: Mental Health: Change from baseline in Brief Psychiatric Rating Scale (BPRS)
timeFrame: Up to 30 days
measure: Mental Health: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 30 days
measure: Pharmacodynamic assessment: The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale
timeFrame: up to 1 hour after dosing
measure: Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)
timeFrame: up to 1 hour after dosing
measure: Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)
timeFrame: up to 1 hour after dosing
measure: Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)
timeFrame: up to 1 hour after dosing
measure: Cognitive Function: Change from baseline in Psychomotor Vigilance Task (PVT)
timeFrame: Up to 7 days
measure: Cognitive Function: Change from baseline in Auditory Verbal Learning Test (AVLT)
timeFrame: Up to 7 days
measure: Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task
timeFrame: Up to 7 days
measure: Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST)
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: GH Research Clinical Trial Site
Study officials:
affiliation: GH Research Ireland Limited
name: GH Research Clinical Team
role: STUDY_DIRECTOR
References: