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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Determination of adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Lab test exclusion criteria
- •On screening
- •Positive serology test.
- •Chemistry, Haematology and Urine laboratory screening results not within the normal range, or being assessed as clinically significant by the attending physician
- •Abnormal Liver and kidney function test.
- •Positive hCG for female subjects.
- •On Admission:
- •The intake of caffeine, xanthene, or CO2-containing beverages within 24 hours of drug administration.
- •Consumption of alcohol, grapefruit or grapefruit containing products within 7 days of drug administration
- •Ingestion of any supplements like vitamins or herbal products within 7 days prior to each drug administration study.
- •Clinically significant illness 4 weeks before study Period I
- •Exhausting physical exercise in the last 24 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- •Abnormal vital signs and being assessed as clinically significant.
- •Vomiting, diarrhea on admission.
- •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.
- •Participation in another bioequivalence study and/or clinical trials within 80 days prior to the start of this study Period.
- •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.
- •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.
- •Subject taking monoamine oxidase inhibitors medications.
- •Subject taking selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) medications.
- •Subject taking uridine diphosphate glucuronosyl transferase enzyme modulators medication.
- •Pre-dosing blood pressure less than 110/70 mmHg.
- •Pre-dosing heart rate less than 70 beats per minute.
研究组 & 干预措施
10 normal healthy male volunteers
10 normal healthy male volunteers where each subject was given an identification code after signing the informed consent which was obtained according to APIC/PRU procedure of obtaining Consent form. The identification code consisted of the subject's initials, and a serial number.
干预措施: Psilocin (Drug)
结局指标
主要结局
Determination of adverse events
时间窗: 28 days
Frequency
次要结局
未报告次要终点