Study Results
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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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2019-03-13
2019-10-04
Brief Summary
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The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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GH001 dose A
5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
GH001 dose B
5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
GH001 dose C
5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
GH001 dose D
5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
GH001 Individualized Dosing
5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Interventions
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5 Methoxy N,N Dimethyltryptamine
GH001 administered via inhalation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 received any investigational medication within the last 1 month.
* Has a medically significant condition, which renders the subject unsuitable for the study.
18 Years
45 Years
ALL
Yes
Sponsors
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GH Research Ireland Limited
INDUSTRY
Responsible Party
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Principal Investigators
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GH Research Clinical Team
Role: STUDY_DIRECTOR
GH Research Ireland Limited
Locations
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Clinical Trial Site
Maastricht, , Netherlands
Countries
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References
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Reckweg J, Mason NL, van Leeuwen C, Toennes SW, Terwey TH, Ramaekers JG. A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N, N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers. Front Pharmacol. 2021 Nov 25;12:760671. doi: 10.3389/fphar.2021.760671. eCollection 2021.
Other Identifiers
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2018-003632-68
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GH001-HV-101
Identifier Type: -
Identifier Source: org_study_id
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