Phase 1, Open-Label, One-Treatment, Single-Dose, One-Period, Pharmacokinetic Study of Psilocin 4 mg as Its Mucic Acid Salt (L-130) Form, in Healthy Subjects Under Fasted Conditions

PSIL22060

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.

2023-06-21

2023-07-30

2023-07-30

Completed

Early phase I

10

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. The 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 (e.g. weight lifting) 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 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. 9. Participation in another bioequivalence study and/or clinical trials within 80 days prior to the start of this study Period. 10. Have been taking medication that could affect the investigated drug product: a) Regular consumption of drugs during the b) consumption of enzyme stimulating or inhibiting drugs (e.g. Barbiturates, Carbamazepine, Phenytoin, Amphetamine, Benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine and methadone) during two weeks before the study initiation. 11. Subject taking medications that belongs to strong CYP3A4 inhibitors (including, but not limited to, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir) or inducers (e.g., phenytoin, rifampicin, carbamazepine, phenobarbital and St. John's Wort) within 4 weeks prior to study. 12. Subject taking monoamine oxidase inhibitors medications. 13. Subject taking selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) medications. 14. Subject taking uridine diphosphate 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2023-09-13