NCT05478278

An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics

A Phase 1, Two-Part Study in Healthy Volunteers to Evaluate The Effect of Psilocybin on Cardiac Repolarization and The Effect of Food on Psilocybin Pharmacokinetics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Usona Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is comprised of two parts. The purpose of the first part of this study is to evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization. The purpose of the second part of the study is to evaluate the effects of food on the pharmacokinetics of psilocybin.

Detailed description

Part one of this study will be a double-blind, single-dose, randomized, placebo-controlled, 4-treatment, 4-period, 12-sequence crossover design in 36 healthy volunteers (adult male and/or female subjects). Subjects will be randomly assigned to 1 of 12 different treatment administration sequences, whereby each sequence will include 3 double-blind treatments (therapeutic dose of psilocybin, supratherapeutic dose of psilocybin, and placebo) and 1 open-label positive control treatment (moxifloxacin). Part two of this study will be an open-label, randomized, 2-period, 2-sequence crossover design in 24 healthy volunteers (adult male and/or female subjects). Each assigned treatment will be administered under fasting or fed conditions as a single dose on Day 1 of the respective study period.

Conditions

• QTc Interval
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Psilocybin	The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains psilocybin (API only in a capsule).
DRUG	Moxifloxacin	The positive comparator used in this study is a 400 mg moxifloxacin tablet.
DRUG	Micro-Crystalline Cellulose	The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.

Timeline

• Start date: 2022-06-22
• Primary completion: 2023-08-09
• Completion: 2023-08-09
• First posted: 2022-07-28
• Last updated: 2023-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study