Pharmacokinetics of GH001 in Healthy Volunteers
Randomized, double-blind, placebo-controlled single-dose and open-label multiple-dose Phase I study in healthy volunteers (n=46) assessing inhaled GH001 (5‑MeO‑DMT) at 6, 12 and 18 mg for pharmacokinetics, safety and psychoactive effects.
Details
This Phase I study in healthy volunteers used a randomized, double-blind, placebo-controlled parallel design for single inhaled doses (6, 12, 18 mg; groups A–C) and an open-label, non-randomized multiple-dose part with up to three inhaled doses in one day (6→12→18 mg; groups D–E) to characterise serum pharmacokinetics of 5‑MeO‑DMT (GH001) and its metabolite bufotenine.
Secondary assessments included safety and tolerability, acute psychoactive effects and cognitive measures; masking was triple (participant, investigator, outcomes assessor) for the single-dose, placebo-controlled part.