Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects (DHTP)
Randomised Phase I study (n=16) comparing PK/PD and safety of six varying doses of a fixed-combination of DMT and harmine across six study days in healthy volunteers with continuous psychological support.
Details
Randomised allocation to one of two sequences (Sequence A or B). Each participant undergoes six study days with a minimum of one day between days; sequences differ by dose order and by inclusion of study days containing only one active ingredient to cover combination effects in a factorial manner.
Pharmacokinetic and pharmacodynamic assessments are obtained over 24 hours on each study visit to estimate dose–exposure relationships and drug–drug interaction; safety/tolerability is monitored continuously and participants receive psychological support in a controlled environment.