Bioavailability Study of Psilocybin in Normal Adults

Healthy Clinical Trial

Official title:

A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05467761
• Other study ID #: 2022-0612
• Secondary ID: A561000PHARM/PHA
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2023
• Est. completion date: March 2024

Study information

• Verified date: May 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Psilocybin, when delivered to screened and prepared participants in a controlled environment, has shown strong evidence of positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. Psilocybin is very rapidly transformed to the active metabolite psilocin, which is considered the active agent from psilocybin administration. Oral and IV psilocybin are expected to have similar pharmacokinetic and psychedelic effects, as well as safety profiles, while IV psilocybin will achieve more consistent blood levels than are possible with oral psilocybin.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Oral Psilocybin
25mg orally
• IV Psilocybin
5mg intravenously

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	TRYP Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults	The incidence and severity of expected and unexpected adverse events will be collected using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials	12 weeks
Secondary	Suicidal ideation	Assessed using the Columbia - Suicide Severity Rating Scale (C-SSRS) at every in-person visit	12 weeks