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Safety of GH001 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04640831
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
GH Research Ireland Limited

Study Description
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Brief Summary:

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.

The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: 5 Methoxy N,N Dimethyltryptamine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-ranging Study of GH001 in Healthy Volunteers
Actual Study Start Date : March 13, 2019
Actual Primary Completion Date : October 4, 2019
Actual Study Completion Date : October 4, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: GH001 dose A Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 dose B Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 dose C Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 dose D Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT
Experimental: GH001 Individualized Dosing Drug: 5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Names:
  • GH001
  • 5-MeO-DMT


Outcome Measures
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Primary Outcome Measures :
  1. The safety and tolerability of GH001 [ Time Frame: up to 7 days ]
    The safety and tolerability of GH001 is judged by the Study Safety Group based on a combined analysis of reported adverse events, clinical observation, and safety laboratory analyses.

  2. The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale [ Time Frame: Retrospectively assessed at 3 hours ]
    Visual Analogue Scale scored from 0-100


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive);
  • Subject is in good general health in the opinion of the medical supervisor;
  • Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview;

Exclusion Criteria:

  • Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
  • Has received any investigational medication within the last 1 month.
  • Has a medically significant condition, which renders the subject unsuitable for the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640831


Locations
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Netherlands
Clinical Trial Site
Maastricht, Netherlands
Sponsors and Collaborators
GH Research Ireland Limited
Investigators
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Study Director: GH Research Clinical Team GH Research Ireland Limited
More Information
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Responsible Party: GH Research Ireland Limited
ClinicalTrials.gov Identifier: NCT04640831    
Other Study ID Numbers: GH001-HV-101
2018-003632-68 ( EudraCT Number )
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GH Research Ireland Limited:
healthy volunteers
5-MeO-DMT
5-methoxy-dimethyltryptamine
Additional relevant MeSH terms:
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N,N-Dimethyltryptamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
 Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists