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

NCT05478278 | Completed Phase 1 FDA Drug

• 1 other identifier: PSIL102-TQT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

QTc Interval; Pharmacokinetics

Keywords

Psilocybin, Psychedelics

Outcome Measures

Primary Outcomes (4)

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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to 24 hours post-dose

Secondary Outcomes (2)

• Part 1: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0.

  Up to 30 Days Post Dose

• Part 2: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0

  Up to 15 Days Post Dose

Study Arms (6)

Part 1: Treatment A (IP at Therapeutic Dose)

EXPERIMENTAL

A single therapeutic dose of psilocybin.

Drug: Psilocybin

Part 1: Treatment B (IP at Supratherapeutic Dose)

EXPERIMENTAL

A single supratherapeutic dose of psilocybin.

Drug: Psilocybin

Part 1: Treatment C (Placebo - Negative Control)

PLACEBO COMPARATOR

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

Drug: Micro-Crystalline Cellulose

Part 1: Treatment D (Placebo - Positive Control)

ACTIVE COMPARATOR

A single 400 mg dose of moxifloxacin.

Drug: Moxifloxacin

Part 2: IP at Therapeutic Dose (Fasted Conditions)

EXPERIMENTAL

A single therapeutic dose of psilocybin administered under fasted conditions.

Drug: Psilocybin

Part 2: IP at Therapeutic Dose (Fed Conditions)

EXPERIMENTAL

A single therapeutic dose of psilocybin under fed conditions.

Drug: Psilocybin

Interventions

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).

Also known as: Psilocybine, Psilocibin, Indocybin

Part 1: Treatment A (IP at Therapeutic Dose); Part 1: Treatment B (IP at Supratherapeutic Dose); Part 2: IP at Therapeutic Dose (Fasted Conditions); Part 2: IP at Therapeutic Dose (Fed Conditions)

Moxifloxacin DRUG

The positive comparator used in this study is a 400 mg moxifloxacin tablet.

Also known as: Avelox, Moxeza

Part 1: Treatment D (Placebo - Positive Control)

Micro-Crystalline Cellulose DRUG

The placebo used in this study is encapsulated using a HPMC capsule and contains micro-crystalline cellulose.

Part 1: Treatment C (Placebo - Negative Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Usona Institute: lead

Study Sites (1)

Altasciences Clinical Kansas, Inc

Overland Park, Kansas, 66212, United States

Location

Related Publications (16)

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  BACKGROUND

Related Links

• ICH Safety Guidelines

MeSH Terms

Interventions

Psilocybin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 28, 2022
• Study Start: June 22, 2022
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

US (1)