Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects

Condition(s) studied

Investigational drug(s) / intervention(s)

5 Methoxy N,N Dimethyltryptamine: GH001 administered via inhalation

GH001 Aerosol Delivery System: GH001 aerosol delivery system

Study summary

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.

Eligibility

Primary outcome measure(s)

• Serum PK parameters of mebufotenin - maximum observed concentration (Cmax) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - time of maximum observed concentration (Tmax) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - terminal elimination half-life (t1/2) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - area under the serum concentration-time curve extrapolated to infinity (AUCinf) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - Partial area under the curve between t1 and t2 (AUCt1-t2) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - terminal elimination rate constant (λz) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - apparent total body clearance (CL/F) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - Apparent volume of distribution (up to bioavailability) following extravascular administration (Vz/F) — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Serum PK parameters of mebufotenin - Cmax/AUCinf — Day 1
  For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH001 to determine mebufotenin serum concentrations.
• Safety and tolerability: incidence of treatment-emergent adverse events — Through trial completion, an average of 3 weeks
  Incidence of adverse events reported in the study and coded by MedDRA.

Trial sites (1)