Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects

Abstract

This is an open-label Phase 1 trial in healthy subjects designed to characterize the pharmacokinetic (PK) profile, pharmacodynamics, and safety and tolerability of GH001 (mebufotenin) delivered via the GH001 Aerosol Delivery System (ADS). The trial is conducted in three parts. In Part 1, subjects receive a single dose of GH001 via the ADS. In Part 2, subjects receive GH001 via both the ADS and the Volcano Medic 2 Vaporization System in a crossover design, to estimate the relative bioavailability of mebufotenin between the two delivery systems. In Part 3, subjects receive a single-day individualized dosing regimen (IDR) of GH001 via the ADS, in which up to three increasing doses are given at approximately 1-hour intervals. The primary objectives are to determine the serum PK profile of mebufotenin and its metabolites and to evaluate the safety and tolerability of GH001 across these parts. Secondary objectives include characterizing the pharmacodynamic profile, as assessed by its psychoactive effects (PsE) and effects on cognitive performance, and estimating the time for the maximum serum concentration (Cmax) to decline by 50% and 90% (tCmax/2 and tCmax/10). Part 3 of this trial was not initiated. The trial was terminated after Part 2.

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