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NCT05478278 · ClinicalTrials.gov registry record · Phase 1
An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics
A Phase 1 study, sponsored by Usona Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT05478278: Completed Phase 1 study, sponsored by Usona Institute.
NCT05478278 is a Phase 1 study that has completed, run by Usona Institute. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05478278, a Phase 1 study, has completed, sponsored by Usona Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording at the -0.75, -0.50, and -0.25 hours prior to dosing and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose.
Interventions
- DRUG Psilocybin
- DRUG Moxifloxacin
- DRUG Micro-Crystalline Cellulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2023-08-09 |
| Phase | Phase 1 |
What the finished NCT05478278 record still lists
NCT05478278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Psilocybin is the first listed.
NCT05478278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05478278 about?
NCT05478278 is a clinical study titled "An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics". 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.
What is the current status of trial NCT05478278?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-06-22. Estimated completion is 2023-08-09.
What interventions are being tested in trial NCT05478278?
The interventions under investigation include: Psilocybin (DRUG), Moxifloxacin (DRUG), Micro-Crystalline Cellulose (DRUG).
Who is sponsoring clinical trial NCT05478278?
This trial is sponsored by Usona Institute, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05478278's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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