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

Usona Institute

Status and phase: Completed; Phase 1

Conditions: QTc Interval; Pharmacokinetics

Treatments: Drug: Micro-Crystalline Cellulose; Drug: Psilocybin; Drug: Moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05478278

PSIL102-TQT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 6 patient groups, including a placebo group

Part 1: Treatment A (IP at Therapeutic Dose)

Experimental group

Description:

A single therapeutic dose of psilocybin.

Treatment:

Drug: Psilocybin

Part 1: Treatment B (IP at Supratherapeutic Dose)

Experimental group

Description:

A single supratherapeutic dose of psilocybin.

Treatment:

Drug: Psilocybin

Part 1: Treatment C (Placebo - Negative Control)

Placebo Comparator group

Description:

A single dose of placebo-to-match psilocybin MCC capsules.

Treatment:

Drug: Micro-Crystalline Cellulose

Part 1: Treatment D (Placebo - Positive Control)

Active Comparator group

Description:

A single 400 mg dose of moxifloxacin.

Treatment:

Drug: Moxifloxacin

Part 2: IP at Therapeutic Dose (Fasted Conditions)

Experimental group

Description:

A single therapeutic dose of psilocybin administered under fasted conditions.

Treatment:

Drug: Psilocybin

Part 2: IP at Therapeutic Dose (Fed Conditions)

Experimental group

Description:

A single therapeutic dose of psilocybin under fed conditions.

Treatment:

Drug: Psilocybin