CompletedPhase 1

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

United States60 participantsStarted 2022-06-22

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provision of signed and dated informed consent form (ICF) * Stated willingness to comply with all study procedures and availability for the duration of the study * Healthy adult male or female * Aged at least 18 years but not older than 65 years, inclusive * Body mass index (BMI) within 18.0 kg/m2 to 32.0 kg/m2 (for Part 1) or to 33.0 kg/m2 (for Part 2), inclusively Exclusion Criteria: * History of significant hypersensitivity to psilocybin or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs * Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability * History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease * Showing suicidal ideation or behavior as per the Columbia Suicide Severity Rating Scale (C-SSRS) administered at screening * Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 200 msec, QRS \< 60 msec, QRS \>110 msec and QTcF \> 450 msec for males and \> 470 for females) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator * History of risk factors for Torsades de Pointes (TdP), including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory asse…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin.

Timeframe: Up to 24 hours post-dose

Part 2: Change from baseline (T=0 hours) of AUC of psilocybin and its metabolite psilocin following up to 24 hours post administration of a therapeutic dose of psilocybin under fed and fasted conditions.

Timeframe: Up to 24 hours post-dose

Part 2: Change from baseline (T=0 hours) of Cmax of psilocybin and its metabolite psilocin following up to 24 hours post administration of a therapeutic dose of psilocybin under fed and fasted conditions.

Timeframe: Up to 24 hours post-dose

Part 2: Change from baseline (T=0 hours) of Tmax of psilocybin and its metabolite psilocin following up to 24 hours post administration of a therapeutic dose of psilocybin under fed and fasted conditions.

Timeframe: Up to 24 hours post-dose

Trial details

NCT IDNCT05478278

SponsorUsona Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-09

View on ClinicalTrials.gov More QTc Interval trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin.

Timeframe: Up to 24 hours post-dose