Clinical TrialHealthy VolunteersPsilocybinCompleted

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

Phase I open-label single-group study (n=10) assessing safety, tolerability and pharmacokinetics of a single oral L-130 capsule (psilocin mucate; reported 4 mg) in healthy male volunteers under fasting conditions.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label, single-group First-in-Man study to determine safety, pharmacokinetics and bioavailability of psilocin mucate (L-130) after a single oral fasting dose in healthy male volunteers (n=10).

Subjects were hospitalised for PK sampling with pre-dose and 13 post-dose blood samples over 24 hours; safety monitoring included vital signs, ECG, MMSE at ~2 hours, AE queries, and follow-up phone calls at 1 week and 4 weeks.

Study Protocol

Preparation

sessions

Dosing

1 sessions
1440 min each

Integration

sessions

Study Arms & Interventions

Psilocin mucate

experimental

Single-group single oral dose of L-130 (psilocin mucate) in healthy male volunteers

Interventions

  • Psilocybin4 mg
    via Oral• single dose• 1 doses total

    L-130 capsules: 2 mg psilocin base reported as equivalent to 4 mg psilocin mucate salt; single fasting dose; formulation of Lobe Sciences Ltd.

Participants

Ages
21 – 50
Sexes
male

Inclusion Criteria

  • 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.
  • Lab test inclusion criteria: 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.

Exclusion Criteria

  • Lab test exclusion criteria: On screening
  • 1. Positive serology test.
  • 2. Chemistry, Haematology and Urine laboratory screening results not within the normal range, or being assessed as clinically significant by the attending physician.
  • 3. Abnormal Liver and kidney function test.
  • 4. Positive hCG for female subjects.
  • On Admission:
  • 1. Intake of caffeine, xanthene, or CO2-containing beverages within 24 hours of drug administration.
  • 2. Consumption of alcohol, grapefruit or grapefruit containing products within 7 days of drug administration.
  • 3. Ingestion of any supplements like vitamins or herbal products within 7 days prior to each drug administration study.
  • 4. Clinically significant illness 4 weeks before study Period I.
  • 5. Exhausting physical exercise in the last 24 hours or any recent significant change in dietary or exercise habits.
  • 6. Abnormal vital signs and being assessed as clinically significant.
  • 7. Vomiting, diarrhea on admission.
  • 8. Subjects with concurrent medication must stop 14 days before drug administration and during study period especially warfarin, aspirin, NSAIDs, levodopa, antipsychotics, fibrates, ciclosporin, fusidic acid.
  • 9. Participation in another bioequivalence study and/or clinical trials within 80 days prior to the start of this study Period.
  • 10. Regular consumption of drugs affecting the study drug (e.g., barbiturates, carbamazepine, phenytoin, amphetamine, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, methadone) within two weeks before study initiation.
  • 11. Taking strong CYP3A4 inhibitors or inducers within 4 weeks prior to study.
  • 12. Taking monoamine oxidase inhibitors.
  • 13. Taking SSRI/SNRI medications.
  • 14. Taking UDP-glucuronosyl transferase enzyme modulators medication.
  • Pre-dose:
  • 1. Pre-dosing blood pressure less than 110/70 mmHg.
  • 2. Pre-dosing heart rate less than 70 beats per minute.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2023-06-21
    End: 2023-07-30
  • Compound
    Psilocybin
  • Topic
    Healthy Volunteers

Locations

Pharmaceutical Research Unit — Amman, Jordan

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