An Open Label ,Phase I, 2-way Crossover Study Evaluating the Pharmacokinetics of Prana P1 THC Activated Capsules
试验速览
- 阶段
- 1 期
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration( Cmax) of following a single dose of 10 mg Prana 1
研究概览
简要总结
This is a single dose clinical trial to assess the Pharmacokinetics of two (2) dosages; 10 mg and 20mg of THC: THCa of Prana P1 bionutrients in healthy volunteers.
详细描述
Single oral dose, (10 mg Prana P1 or 20 mg Prana P1) in each period with a washout of 30 days between doses. Patents will be randomly assigned dose for the first round of the study after a thirty-day washout, patient will return to the study site and receive cross over dose.
Metabolites to be Measured:
- THC
- 11-OH-THC [primary secondary metabolite of THC, psychoactive]
- THC-COOH [inactive metabolite]
The following parameters for THC, 11-OH-THC, and THC-COOH will be assessed: AUC0-t, AUC0-inf, Cmax, AUCt/inf, Tmax.
Safety will be monitored and assessed through adverse events reports, 12-lead ECG, vital signs and laboratory parameters. Each participant will undergo a psychometric evaluation using the CHAT assessment tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males between 18 and 55 years.
- •Body weight with a Body Mass Index (BMI) range of 18.5 to 27.0 [or weight within 15% of ideal weight for participant's height and frame
- •Healthy, with normal findings in the physical examination and vital signs (BP between 100-140/60-90 mmHg, Heart rate (HR) between 60 to 90 beats/min, respiration between 12 to 24 breaths/min) and no clinically-significant findings in a 12-lead ECG.
- •No clinical laboratory values outside of the laboratory normal reference range, unless the investigator determines them to be not clinically significant.
- •Negative for hepatitis B surface antigen, hepatitis C antibody, HIV --Willing and able to communicate well with the investigator and clinic staff, comply with the study procedure and schedule, and provide written informed consent.
- •Able to understand the requirements of the study and sign Informed Consent.
排除标准
- •Current major Axis I psychiatric disorder for which the participant is currently receiving treatment or which would make study compliance an issue.
- •Any condition or therapy that, in the opinion of the investigator, may be significantly worsened by the exposure to marijuana.
- •Acute disease at the time of enrolment (i.e., presence of a moderate or severe illness or infection with or without a fever).
- •Febrile illness (oral temperature >37.6° C at the time of drug administration).
- •Unstable chronic illnesses.
- •Chronic liver, renal or inflammatory bowel disease or collagen vascular disease.
- •Clinically significant elevation of Alanine transaminase(ALT) and/or Aspartate transaminase (AST).
- •Active neurological disorder.
- •Clinically significant uncontrolled illness or clinically significant surgery within 4 weeks prior to administration of study drug.
- •Cancer within the previous 5 years, other than squamous cell or basal cell carcinoma of the skin.
- •Difficulty to swallow study medication.
- •Smoking more than 25 cigarettes per day.
- •History of any clinical laboratory abnormality deemed significant by the Principal Investigator.
- •History of serious adverse reaction or hypersensitivity to any drug.
- •Bleeding tendency resulting from disease or medication rendering blood collection or the injection itself unsafe (use of antiplatelet agents is allowed).
- •Coagulation disorders or receiving anticoagulant therapy.
- •Inability to tolerate abstinence from caffeine for 24 hours prior to and during the study treatment phase.
- •Consumption of alcohol within 24 hours prior to dosing and during the treatment phase.
- •History of significant alcohol or drug abuse within one year prior to the screening visit
- •Chronic use (i.e., ≥3 days per week) of marijuana based products within 3 months prior to the screening visit.
- •Use of hard recreational drugs (such as cocaine, phencyclidine [PCP] and crack) within one year prior to the screening visit.
- •Donation of plasma (500 mL) within 7 days prior to drug administration
- •Any known or suspected allergy to any constituent of marijuana.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigators, contraindicates the participant 's participation in this study.
- •Use of any investigational or non-registered drug or participation in an investigational study within 30 days prior to administration of study drug.
研究组 & 干预措施
10 mg P1
10 mg of P1 will be administered and compared with an active dose of 20 mg P1 on crossover
干预措施: P1 (Drug)
20 mg P1
20 mg of P1 will be administered and compared with an active dose of 10 mg P1 on crossover
干预措施: P1 (Drug)
结局指标
主要结局
Peak Plasma Concentration( Cmax) of following a single dose of 10 mg Prana 1
时间窗: At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs
Maximum plasma concentration of Prana P1 following a single dose of 10 mg of Prana P1 1. Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC. Pk endpoints of THC(0-48 hours post-dose) 2. PK endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (T- 0-24 hours post-dose) Mean Cmax of 11-OH-THC. Mean AUC(0-t)) of 11-OH-THC. 3. PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.
Peak Plasma Concentration( Cmax) of following a single dose of 20 mg Prana 1
时间窗: At time points, 0, 0.5hr, 1hr, 2 hr, 3hr, 4 hr, 5hr, 6hr, 8hr, 10hr, 12 hr, 24hrs, 32hrs , 48 hrs
Maximum plasma concentration of Prana P1 following a single dose of 20 mg of Prana P1 1. Pk endpoints of delta 9-tetrahydrocannabinol (THC) (0-24 hours post-dose) (Cmax) of THC. Pk endpoints of THC(0-48 hours post-dose) 2. PK endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (T- 0-24 hours post-dose) Mean Cmax of 11-OH-THC. Mean AUC(0-t)) of 11-OH-THC. 3. PK endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (Time: 0-24 hours post-dose) Mean Cmax of 11-COOH-THC.
次要结局
- Number of participants with treatment related adverse events as assessed by CTCAE v 5.0(up to 30 days post dose)
- Number of participants who discontinue treatment due to side effects(up to 30 days)
研究者
Shelly Rosemarie McFarlane
Coordinating Investigator
The University of The West Indies