Trial record 1 of 1 for:
Usona Food Effect
An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics
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| ClinicalTrials.gov Identifier: NCT05478278 |
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Recruitment Status :
Recruiting
First Posted : July 28, 2022
Last Update Posted : May 15, 2023
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Sponsor:
Usona Institute
Information provided by (Responsible Party):
Usona Institute
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| QTc Interval Pharmacokinetics | Drug: Psilocybin Drug: Moxifloxacin Drug: Micro-Crystalline Cellulose | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | June 22, 2022 |
| Estimated Primary Completion Date : | August 2023 |
| Estimated Study Completion Date : | December 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1: Treatment A (IP at Therapeutic Dose)
A single therapeutic dose of psilocybin.
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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).
Other Names:
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Experimental: Part 1: Treatment B (IP at Supratherapeutic Dose)
A single supratherapeutic dose of psilocybin.
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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).
Other Names:
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Placebo Comparator: Part 1: Treatment C (Placebo - Negative Control)
A single dose of placebo-to-match psilocybin MCC capsules.
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Drug: Micro-Crystalline Cellulose
The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose. |
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Active Comparator: Part 1: Treatment D (Placebo - Positive Control)
A single 400 mg dose of moxifloxacin.
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Drug: Moxifloxacin
The positive comparator used in this study is a 400 mg moxifloxacin tablet.
Other Names:
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Experimental: Part 2: IP at Therapeutic Dose (Fasted Conditions)
A single therapeutic dose of psilocybin administered under fasted conditions.
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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).
Other Names:
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Experimental: Part 2: IP at Therapeutic Dose (Fed Conditions)
A single therapeutic dose of psilocybin under fed conditions.
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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).
Other Names:
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Primary Outcome Measures :
- Part 1: Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin. [ Time Frame: Up to 24 hours post-dose ]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.
- 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. [ Time Frame: Up to 24 hours post-dose ]Pharmacokinetic endpoints for psilocybin and psilocin (AUC) will be evaluated at 0.00, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 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. [ Time Frame: Up to 24 hours post-dose ]Pharmacokinetic endpoints for psilocybin and psilocin (CMax) will be evaluated at 0.00, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 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. [ Time Frame: Up to 24 hours post-dose ]Pharmacokinetic endpoints for psilocybin and psilocin (TMax) will be evaluated at 0.00, 0.25, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose.
Secondary Outcome Measures :
- Part 1: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0. [ Time Frame: Up to 30 Days Post Dose ]Number of participants with TEAEs following administration of psilocybin and moxifloxacin.
- Part 2: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0 [ Time Frame: Up to 15 Days Post Dose ]Number of participants with TEAE following administration of psilocybin.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 assessments including hypokalemia, hypercalcemia, or hypomagnesaemia
- Family history of long QT syndrome or Brugada syndrome
- Any clinically significant illness in the 28 days prior to the first study drug administration
- Intake of psilocybin or any other psychedelic (including 3,4-methylenedioxymethamphetamine [MDMA] and ketamine) in the 28 days prior to the first study drug administration
- Not suitable for participation in the study at the discretion of the Principal Investigator
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05478278
Contacts
| Contact: Christina Behlke, PhD | (608) 298-4854 | ClinicalTrials@usonainstitute.org |
Locations
| United States, Kansas | |
| Altasciences Clinical Kansas, Inc | Recruiting |
| Overland Park, Kansas, United States, 66212 | |
| Contact: Recruitment Manager 913-696-1601 volunteersinfo@altasciences.com | |
Sponsors and Collaborators
Usona Institute
Additional Information:
Publications:
Publications:
Sischka PE, Costa AP, Steffgen G, Schmidt AF. The WHO-5 well-being index - validation based on item response theory and the analysis of measurement invariance across 35 countries. Journal of Affective Disorders Reports. 2020;1(100020).
| Responsible Party: | Usona Institute |
| ClinicalTrials.gov Identifier: | NCT05478278 |
| Other Study ID Numbers: |
PSIL102-TQT |
| First Posted: | July 28, 2022 Key Record Dates |
| Last Update Posted: | May 15, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Usona Institute:
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Psilocybin, Psychedelics |
Additional relevant MeSH terms:
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Physiological Effects of Drugs Moxifloxacin Psilocybin Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors |
Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hallucinogens Psychotropic Drugs |