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WithdrawnPhase 1

Bioavailability Study of Psilocybin in Normal Adults

NCT05467761 · University of Wisconsin, Madison

Closed to entry
Status
Not accepting participants
Phase 1
Phase
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin

    Measured over Day 8, Day 22

  • Determine the concentration of psilocin following oral and IV administrations of psilocybin

    Measured over Day 8, Day 22

  • Determine the concentration of psilocin following oral and IV administrations of psilocybin

    Measured over Day 8, Day 22

  • Determine the concentration of psilocin following oral and IV administrations of psilocybin

    Measured over Day 8, Day 22

  • Difference in the area under plasma concentration-time curve (AUC) between psilocybin administration methods.

    Measured over Day 8, Day 22

  • Difference in the maximum concentration (Cmax) between psilocybin administration methods.

    Measured over Day 8, Day 22

  • Difference in the time to maximum plasma concentration (Tmax) between psilocybin administration methods.

    Measured over Day 8, Day 22

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Overall healthy and medically stable, as determined by screening * Capable of giving signed informed consent * Negative urine pregnancy test in persons of childbearing potential Exclusion Criteria: * Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, prior myocardial infarction, tachycardia, artificial heart valve, corrected QT interval (QTc) \>450 msec at screening, any other clinically significant screening ECG abnormality, or any other significant cardiovascular condition * Presence of a gastrointestinal disease that could interfere with absorption of an orally administered drug * Have epilepsy * Positive urine drug test * Prior adverse effects from psilocybin or other psychedelics that required hospitalization * Currently taking on a regular basis (e.g., daily) any medications having a primary centrally acting serotonergic effect, including selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), or serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort) * Currently taking prohibited medications, including antihypertensive medications, UGT1A9 or 1A10 inhibitors (e.g., regorafenib, rifampicin, phenytoin, eltrombopag, mefenamic acid, diflunisal, niflumic acid, sorafenib, isavuconazole, deferasiroxor, ginseng), and aldehyde or alcohol dehydrogenase inhibitors (e.g,, disulfiram) * Participation in another concurrent clinical study; or use of investigational drugs, biologics, or devices within 30 days prior to assignment of study drug administration order * Anyone who is pregnant, lactating, or planning on becoming pregnant during the study * Unwilling to withhold prohibited concomitant medications

Where

1 study site

FacilityCityRegionCountry
University of WisconsinMadisonWisconsinUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05467761 on ClinicalTrials.gov →

Last updated in the registry 2023-05-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits