Evaluation of Safety, Rate and Extent of Absorption of Psilocin Mucate

NCT06035900 | Completed Phase 1

• 1 other identifier: PSIL22060
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Psilocin is the active metabolite of psilocybin a natural material found in several types of fungi. The bioavailability of psilocybin, the prodrug of psilocin, has been reported to be over 60%. However, pharmacokinetics and bioavailability of psilocin mucate has not been reported. This Phase I "First in Man" study of psilocin mucate is designed to determine its safety, pharmacokinetics, and bioavailability. The study is conducted under the supervision of physicians and psychiatrists who also will administer a mini-mental state evaluation and report observable anti-anxiolytic effect of the dosage. Safety and possible indications of efficacy will be tracked during the study period, a week following the dose administration and one month after.

Conditions

Side Effect of Drug

Outcome Measures

Primary Outcomes (1)

• Determination of adverse events

  Frequency

  28 days

Other Outcomes (3)

• Plasma Concentration (Cmax)

  24 hours

• Area Under the plasma concentration versus time curve (AUC)

  24 hours

• Time to maximum plasma concentration (Tmax)

  24 hours

Study Arms (1)

10 normal healthy male volunteers

EXPERIMENTAL

10 normal healthy male volunteers where each subject was given an identification code after signing the informed consent which was obtained according to APIC/PRU procedure of obtaining Consent form. The identification code consisted of the subject's initials, and a serial number.

Drug: Psilocin

Interventions

Psilocin DRUG

single 4mg dose of psilocin mucate was administered to healthy 10 volunteers

Also known as: Psilocin Mucate

10 normal healthy male volunteers

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21-50 years. Body-mass index 18.5 to 30.0 kg/m2 inclusive. (Minimum of 50 kg weight for males and 45 kg for females).
• Subject is available for the whole study period and gave written informed consent.
• Normal physical examination or being assessed as clinically non-significant by the attending physician.
• Normal neurological, cardiovascular, cerebrovascular, gastrointestinal and respiratory systems.
• Normal Vital Signs. Normal Electrocardiogram (ECG). Subjects refraining from alcohol use, other study medication and drugs.
• On Screening Chemistry, Hematology and Urine laboratory screening results within the normal range, or being assessed as clinically non-significant by the attending physician.
• Normal Liver and kidney function test.

You may not qualify if:

• On screening
• Positive serology test.
• Chemistry, Haematology and Urine laboratory screening results not within the normal range, or being assessed as clinically significant by the attending physician
• Abnormal Liver and kidney function test.
• Positive hCG for female subjects.
• On Admission:
• The intake of caffeine, xanthene, or CO2-containing beverages within 24 hours of drug administration.
• Consumption of alcohol, grapefruit or grapefruit containing products within 7 days of drug administration
• Ingestion of any supplements like vitamins or herbal products within 7 days prior to each drug administration study.
• Clinically significant illness 4 weeks before study Period I
• Exhausting physical exercise in the last 24 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
• Abnormal vital signs and being assessed as clinically significant.
• Vomiting, diarrhea on admission.
• Subjects with concurrent medication must be taken 14 days before drug administration and during study period especially warfarin, aspirin, non-steroidal anti-inflammatory drugs, levodopa, antipsychotic medicinal products, fibrates, ciclosporin, fusidic acid (a medicine for bacterial infection), orally and or by injection.
• Participation in another bioequivalence study and/or clinical trials within 80 days prior to the start of this study Period.

Sponsors & Collaborators

• Lobe Sciences Ltd.: lead
• Pharmaceutical Research Unit, Jordan: collaborator

Study Sites (1)

Pharmaceutical Research Unit

Amman, 11910, Jordan

Location

MeSH Terms

Interventions

psilocin

Study Officials

• Ahmad Abdulkhaleq, MD

  Arab Pharmaceutical Industry Pharmaceutical Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The aim of the study is to assess the bioavailability and pharmacokinetic parameters and to monitor the safety and tolerability of a formulation in healthy subjects under fasting conditions after a single oral dose of L-130 Capsules containing 2 mg of psilocin as its Mucic Acid Salt or Conjugate.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 13, 2023
• Study Start: June 21, 2023
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: We hope to complete the trial and receive a final report that will be the source of at least two publications in or around March 2024.
• Access Criteria: We plan to share the data from the pharmacokinetics study with any academic research or medical institution upon written request to the Project Leader and Central Contact Person: Dr. Fred D. Sancilio

Locations

JO (1)