Pharmacokinetics of GH001 in Healthy Volunteers
A Phase 1 Study to Determine the Pharmacokinetics and Pharmacodynamics of Single and Multiple Inhaled Doses of GH001 in Healthy Volunteers
Sponsor: GH Research Ireland Limited
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine
Time frame: up to 4 hours
Secondary Endpoints
Safety: Adverse Event (AE) reporting
Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording
Safety: Frequency of clinically significant changes from baseline in vital signs measurement
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.
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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