Part 1: double-blind, randomized, placebo-controlled 4-period crossover in healthy volunteers (n=36) comparing therapeutic and supratherapeutic psilocybin, placebo, and open-label moxifloxacin; Part 2: open-label randomized 2-period crossover (n=24) assessing food effect on psilocybin pharmacokinetics.
Part 1 is a double-blind, single-dose, randomized, placebo-controlled 4-treatment, 4-period, 12-sequence crossover in 36 healthy adults to evaluate therapeutic and supratherapeutic psilocybin versus placebo with an open-label moxifloxacin positive control for cardiac repolarization assessment.
Part 2 is an open-label randomized 2-period, 2-sequence crossover in 24 healthy adults to evaluate the effect of food (fed vs fasted) on the pharmacokinetics of a single therapeutic dose of psilocybin.
Primary assessments include ECG/QTc (safety and cardiac repolarization) and pharmacokinetic measures; healthy volunteers only; capsules are HPMC-encapsulated psilocybin API or micro-crystalline cellulose placebo.
Single therapeutic dose of psilocybin (Part 1, double-blind crossover).
Therapeutic dose; encapsulated in HPMC; API only.
Single supratherapeutic dose of psilocybin (Part 1, double-blind crossover).
Supratherapeutic (positive safety/PD challenge) dose; encapsulated in HPMC.
Micro-crystalline cellulose placebo to match psilocybin capsules.
Micro-crystalline cellulose in HPMC capsule (placebo).
Open-label positive control (moxifloxacin 400 mg).
Moxifloxacin 400 mg oral (open-label positive control).
Therapeutic psilocybin administered under fasted conditions (Part 2).
Therapeutic dose; fasted condition.
Therapeutic psilocybin administered under fed conditions (Part 2).
Therapeutic dose; fed condition.