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.
An Evaluation of Psilocybin's Effect on Cardiac Repolarization and the Effect of Food on Psilocybin's Pharmacokinetics
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.
Intervention / Treatment
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Psilocybin (DRUG)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).
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Moxifloxacin (DRUG)The positive comparator used in this study is a 400 mg moxifloxacin tablet.
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Micro-Crystalline Cellulose (DRUG)The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.
Condition or Disease
- QTc Interval
- Pharmacokinetics
Phase
Study Design
| Study type: | INTERVENTIONAL |
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| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 60 (ACTUAL) |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingTRIPLE:
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Clinical Trial Dates
| Start date: | Jun 22, 2022 | ACTUAL |
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| Primary Completion: | Aug 09, 2023 | ACTUAL |
| Completion Date: | Aug 09, 2023 | ACTUAL |
| Study First Posted: | Jul 28, 2022 | ACTUAL |
| Last Updated: | Aug 14, 2023 |
Sponsors / Collaborators
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.
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.
Participant Groups
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A single therapeutic dose of psilocybin.
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A single supratherapeutic dose of psilocybin.
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A single dose of placebo-to-match psilocybin MCC capsules.
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A single 400 mg dose of moxifloxacin.
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A single therapeutic dose of psilocybin administered under fasted conditions.
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A single therapeutic dose of psilocybin under fed conditions.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
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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.
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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.
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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 Outcomes
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Number of participants with TEAEs following administration of psilocybin and moxifloxacin.
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Number of participants with TEAE following administration of psilocybin.
More Details
| NCT Number: | NCT05478278 |
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| Other IDs: | PSIL102-TQT |
| Study URL: | https://clinicaltrials.gov/study/NCT05478278 |
Last updated: Sep 29, 2023