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.
