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

NCT05478278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-15

No results posted yet for this study

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

Interventions

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).

DRUG

Moxifloxacin

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

DRUG

Micro-Crystalline Cellulose

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

Sponsors & Collaborators

  • Usona Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2023-08-09
Completion
2023-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05478278 on ClinicalTrials.gov