Bioavailability Study of Psilocybin in Normal Adults

NCT05467761 | Withdrawn Phase 1 DMC FDA Drug

• 4 other identifiers: 2022-0612A561000PHARM/PHARMACY04/21/2022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

psilocybin; psychedelics

Outcome Measures

Primary Outcomes (7)

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

  Determine the maximum plasma concentration of psilocin in plasma following a single IV dose as compared to that following a single oral dose.

  Day 8, Day 22

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

  Determine the time to maximum plasma concentration of psilocin in plasma following a single IV dose as compared to that following a single oral dose.

  Day 8, Day 22

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

  Determine the half-life of psilocin in plasma following a single IV dose as compared to that following a single oral dose.

  Day 8, Day 22

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

  Determine the AUC of psilocin in plasma following a single IV dose as compared to that following a single oral dose.

  Day 8, Day 22

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

  AUC will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.

  Day 8, Day 22

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

  Cmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.

  Day 8, Day 22

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

  Tmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.

  Day 8, Day 22

Secondary Outcomes (2)

• Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults

  12 weeks

• Suicidal ideation

  12 weeks

Study Arms (1)

Oral and IV psilocybin

EXPERIMENTAL

Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water, at one visit. Psilocybin will be administered through IV at the other visit.

Drug: Oral Psilocybin; Drug: IV Psilocybin

Interventions

Oral Psilocybin DRUG

25mg orally

Oral and IV psilocybin

IV Psilocybin DRUG

5mg intravenously

Oral and IV psilocybin

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overall healthy and medically stable, as determined by screening
• Capable of giving signed informed consent
• Negative urine pregnancy test in persons of childbearing potential

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• TRYP Therapeutics: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Christopher Nicholas, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Paul Hutson, PharmD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: June 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)