CBD Cannabis Extract: Pharmacokinetic Studies
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
研究概览
简要总结
The initial goal is to ascertain the pharmacokinetic (PK) profile of CBD (cannabidiol) after a single dose of CBDE (cannabidiol extract), although the plan is to extend these studies to multiple dose administrations in the future, since it is likely that (cannabidiol) and/or its metabolites will show some accumulation. These studies will provide detailed information that will inform the continuation and expansion of CBDE in other research projects.
详细描述
The objective is to determine the PK profile of CBD(cannabidiol) , its metabolites, and minor phytocannabinoids after single dose administration of CBDE (at 2.5 mg/kg CBD). Attainment of this goal will provide essential information on phytocannabinoid disposition and dosing regimen optimization. To accomplish this objective, the working hypothesis that complex phytochemical mixtures present in full spectrum hemp extracts (FSHEs), as exemplified by CBDE, differ from purified CBD-containing products with regard to PK, will be tested. The approach to testing this working hypothesis will be to use liquid chromatography-mass spectrometry (LC/MS) to both characterize the phytocannabinoid concentration-time profiles following CBDE administration (single and multiple dosing).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy adults aged 21 to 55 years
排除标准
- •Allergy to sesame oil/products
- •Obese: BMI is 35 or higher
- •Smoker (tobacco & marijuana use [smoking or use of oral hemp/CBD products])
- •Currently any taking prescriptions medication(s) [with exception of oral contraceptives] or over-the-counter medications/supplements
- •Consuming botanical/non-botanical dietary supplements (3 days prior to study)
- •Known history of cardiac, liver, kidney or hematological disease, diabetes
- •Autoimmune disorders
- •Known history of Neurologic/Psychiatric disorders
- •Report of an active infection
- •Subject is pregnant or breast-feeding, or is expecting to conceive during the study
- •Subjects of child bearing potential will use (or is currently using) during the study, one of the following acceptable methods of contraception:
- •Male sterilization (vasectomy) Female sterilization (tubal ligation, hysterectomy) Intrauterine service intrauterine device (IUD) or other implant Oral contraceptive, injectable contraceptive Contraceptive patch/ring Diaphragm Male condom Sponge/spermicide
研究组 & 干预措施
Cannabidiol extract
10 healthy subjects (5 female, 5 male), will be enrolled into the study. Each subject will receive a single CBDE dose delivering 2.5 mg/kg CBD, after consumption of a standardized meal.
Nine (9mL) of blood for PK analysis, at each of the following timepoints: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the study drug administration.
Urine will be collected at the following timepoints: Predose, 0-4 hrs, 4-8 hrs, 8-12 hrs, 12-24 hrs, 24-36 hrs, 36-48 hrs, and 48-72 hrs for PK analysis
干预措施: cannabidiol extract (Drug)
结局指标
主要结局
Plasma concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
时间窗: 0- 72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers
Urine concentration of minor phytocannabinoids, and metabolites following single dose administration of Cannabis extract (CBDE) (at 2.5 mg/kg cannabidiol (CBD).
时间窗: 0- 72 hours
This study would provide information on differential pharmacokinetics and metabolism of Cannabis extract in normal human volunteers
次要结局
- Area-under-the-concentration-time profiles (AUC), and area-under-the moment curve (AUMC), for CBD (cannabidiol) , up to 72 hours after Cannabis extract administration.(0-72 hours)
- Clearance (Cl/F) up to 72 hours after Cannabis extract administration.(0-72 hours)
- Volume of distribution (Vd),up to 72 hours after Cannabis extract administration.(0-72 hours)
- Mean residence time (MRT), up to 72 hours after Cannabis extract administration.(0-72 hours)
- Maximum serum concentration (Cmax), up to 72 hours after Cannabis extract administration.(0-72 hours)
- Time to reach Cmax (Tmax), up to 72 hours after Cannabis extract administration.(0-72 hours)
- Volume of distribution at steady state (Vdss),up to 72 hours after Cannabis extract administration.(0-72 hours)
- Terminal elimination rate constant (ke), half-life (t1/2), up to 72 hours after Cannabis extract administration.(0-72 hours)