Evaluation of Safety, Rate and Extent of Absorption of Psilocin Mucate
Condition: Side Effect of Drug
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This study is designed to assess the bioavailability and pharmacokinetic parameters and to
      monitor the safety and tolerability of Psilocin 2 mg as its Mucic Acid Salt (L-130) form, a
      proprietary drug candidate of Lobe Sciences Ltd., in healthy subjects under fasted
      conditions.

      The study will be conducted in compliance with the protocol and applicable regulatory
      requirements, GCP and GLP principles and guidelines: Declaration of Helsinki as amended by
      the 64th WMA General Assembly, Fortaleza, Brazil, November 2013, FDA Guidelines for
      Bioavailability & Bioequivalence Studies and OECD Principles of Good Laboratory Practice will
      be observed.

      The study population will consist of 10 Healthy Subjects aged between 21 and 50 years
      (inclusive), body mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight for males
      and 45 kg for females), nonsmokers or quit smoking 24 hours prior to dosing.

      The investigational test product L-130 Capsules containing 2 mg of psilocin as its Mucic Acid
      Salt of Lobe Sciences Ltd. consisted of single oral dose containing 2 mg of Psilocin
      (equivalent to 4 mg as Psilocin Mucate salt).

      Each dose will be administered orally, with 240 mL of water in sitting position under sodium
      light to healthy subjects after an overnight fast of at least 10 hours in the morning of
      study dosing day. The study will be conducted as an open label study. Therefore, blinding
      will not be done. However, the bioanalysis will be performed blinded with regard to the
      sequence of product administration. Each subject will have a pre-dose sample of 8 ml
      collected and 13 additional 8 ml samples collected over a 24 hour period.

      The principal and/ or clinical investigator and study staff will monitor subjects throughout
      the hospitalization periods. Blood pressure and heart rate will be measured before dosing and
      at scheduled intervals after dosing. The principal and/ or clinical Investigator will be
      available throughout each hospitalization period. During outpatient phases, study staff will
      be available during regular working hours.

      Subjects' safety will be observed at scheduled intervals of before dosing (-1.00) and 0.50,
      0.75, 1.00, 2.00, 3.00, 5.00, 8.00, 12.00, 16.00 and 24.00 hours after drug administration.
      Subjects will be queried on adverse events. In addition, voluntary reporting of adverse
      events by subjects will be reported.

      Mini Mental State Examination (MMSE) score will be assessed to dosed subjects by CI/PI
      approximately two hours after drug administration, and the results will be tabulated in the
      final report. Subjects will be asked to report changes in their mood, or other observations
      during and following the study period. Subjects will also be followed up by phone call after
      one week and four weeks of dosing to assess if they are experiencing changes in feeling or
      having improved mood, and the outcomes of the phone calls will be tabulated in the final
      report.

      Following the collection of blood samples and appropriate processing, each sample will be
      analyzed with a validated analytical method to determine the pharmacokinetic profile of
      psilocin mucate in plasma.

      All clinical laboratories test results of screening lab tests will be summarized by
      descriptive statistics. Follow up lab tests will also be summarized by descriptive
      statistics.

      The aim of the study is to assess the bioavailability and pharmacokinetic parameters and to
      monitor the safety and tolerability of the 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. The final report will provide safety, tolerability and pharmacokinetics of
      the test product. The study will also report patient reported pharmacology.
    

Intervention name(s): Psilocin
Intervention type(s): Drug
Intervention description(s): single 4mg dose of psilocin mucate was administered to healthy 10 volunteers
Other intervention name(s): Psilocin Mucate
Intervention MeSH terms: Psilocin
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Basic Science