Evaluation of Safety, Rate and Extent of Absorption of Psilocin Mucate (Psilocin-1)

This Phase I open-label trial (n=10) assessed the safety, pharmacokinetics, and bioavailability of psilocin (4mg) as its Mucic Acid Salt (L-130) form in healthy male volunteers under fasted conditions.

Conducted by Lobe Sciences Ltd., the study aimed to determine the bioavailability and pharmacokinetic parameters of 9silocin mucate, the active metabolite of psilocybin. Healthy subjects aged 21 to 50 with a body mass index of 18.5 to 30.0 kg/m2 were included. The investigational test product, L-130 Capsules containing 2 mg of psilocin, was administered orally after an overnight fast. Safety and pharmacokinetic profiles were monitored over 24 hours post-dose, with blood samples collected at scheduled intervals. Adverse events were recorded, and subjects were followed up via phone calls after one week and four weeks post-dosing.

The primary outcome measures included the determination of adverse events, while secondary measures included plasma concentration (Cmax), area under the plasma concentration versus time curve (AUC), and time to maximum plasma concentration (Tmax).

The study, conducted in Jordan, started on June 21, 2023, and was completed on July 30, 2023. The results are expected to be published in peer-reviewed journals, with data sharing planned for March 2024.

Topic Healthy Subjects
Compound Psilocybin
Visit trial
Status Completed
Results Published No
Start date 21 June 2023
End date 30 July 2023
Phase Phase I
Design Open
Type Interventional
Generation Third
Participants 10
Sex Male
Age 21- 50
Therapy No

Trial Details

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.

NCT Number NCT06035900

Sponsors & Collaborators

Lobe Sciences
Lobe Sciences is a listed (CSE) Canadian company with a focus on treating traumatic brain injury (TBI). It is led by pioneering scientists, engineers, and physicians focused on investigating, researching and developing treatments for brain health through alternative and nontraditional medicines and the latest technologies.

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