CompletedPhase 1

Pharmacokinetics of GH001 in Healthy Volunteers

Netherlands46 participantsStarted 2021-06-21

Plain-language 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.

Who can participate

Age range18 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine

Timeframe: up to 4 hours

Trial details

NCT IDNCT05163691

SponsorGH Research Ireland Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-23

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