At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Psilocybin, Moxifloxacin, and 1 other intervention for QTc Interval and Pharmacokinetics. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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).
The positive comparator used in this study is a 400 mg moxifloxacin tablet.
The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.