Clinical TrialSafety & Risk ManagementPsilocybinPsilocybinPlaceboPsilocybinPsilocybinCompleted

An Evaluation of Psilocybin’s Effect on Cardiac Repolarization

Part 1: double-blind, randomized, placebo-controlled 4-period crossover in healthy volunteers (n=36) comparing therapeutic and supratherapeutic psilocybin, placebo, and open-label moxifloxacin; Part 2: open-label randomized 2-period crossover (n=24) assessing food effect on psilocybin pharmacokinetics.

Target Enrollment
60 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Part 1 is a double-blind, single-dose, randomized, placebo-controlled 4-treatment, 4-period, 12-sequence crossover in 36 healthy adults to evaluate therapeutic and supratherapeutic psilocybin versus placebo with an open-label moxifloxacin positive control for cardiac repolarization assessment.

Part 2 is an open-label randomized 2-period, 2-sequence crossover in 24 healthy adults to evaluate the effect of food (fed vs fasted) on the pharmacokinetics of a single therapeutic dose of psilocybin.

Primary assessments include ECG/QTc (safety and cardiac repolarization) and pharmacokinetic measures; healthy volunteers only; capsules are HPMC-encapsulated psilocybin API or micro-crystalline cellulose placebo.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Therapeutic psilocybin (Part 1)

experimental

Single therapeutic dose of psilocybin (Part 1, double-blind crossover).

Interventions

  • Psilocybin
    via Oral• single dose• 1 doses total

    Therapeutic dose; encapsulated in HPMC; API only.

Supratherapeutic psilocybin (Part 1)

experimental

Single supratherapeutic dose of psilocybin (Part 1, double-blind crossover).

Interventions

  • Psilocybin
    via Oral• single dose• 1 doses total

    Supratherapeutic (positive safety/PD challenge) dose; encapsulated in HPMC.

Placebo (Part 1)

inactive

Micro-crystalline cellulose placebo to match psilocybin capsules.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Micro-crystalline cellulose in HPMC capsule (placebo).

Moxifloxacin (Part 1)

active comparator

Open-label positive control (moxifloxacin 400 mg).

Interventions

  • Compound
    via Oral• single dose• 1 doses total

    Moxifloxacin 400 mg oral (open-label positive control).

Therapeutic psilocybin (Fasted, Part 2)

experimental

Therapeutic psilocybin administered under fasted conditions (Part 2).

Interventions

  • Psilocybin
    via Oral• single dose• 1 doses total

    Therapeutic dose; fasted condition.

Therapeutic psilocybin (Fed, Part 2)

experimental

Therapeutic psilocybin administered under fed conditions (Part 2).

Interventions

  • Psilocybin
    via Oral• single dose• 1 doses total

    Therapeutic dose; fed condition.

Participants

Ages
18 – 65
Sexes
Male & Female

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

Study Details

Locations

Altasciences Clinical Kansas, Inc — Overland Park, Kansas, United States

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