The Pharmacokinetics of Oral Tetrahydrocannabinol and Cannabidiol Across the Spectrum of Glomerular Filtration Rate: a PharmacoKinetic Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Tetrahydrocannabinol and its metabolites renal clearance
研究概览
简要总结
POT-GFR-PK is a single dose pharmacokinetic study oral tetrahydrocannabinol (THC) and cannabidiol (CBD) in healthy adult controls and individuals with chronic kidney disease including those treated with in-center hemodialysis.
详细描述
Adults aged greater than 25 years including 6 with eGFR>60ml/min/1.73m2, 6 eGFR 30-59ml/min/1.73m2, 6 eGFR <30ml/min/1.73m2 (CKD Epidemiology Collaboration equation) and 6 receiving in-center hemodialysis at least 2x weekly via a tunnelled catheter will receive THC 0.1mg/kg and CBD 2mg/kg by mouth in the form of MediPharm Labs-001 (MPL-001) (50mg CBD/2mg THC per 1mL). In healthy controls and participants with chronic kidney disease, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration. In participants receiving in-center hemodialysis, blood samples will be collected at t=0, 1, 2, 3, 3.5 and 4 hours post THC/CBD administration and during hemodialysis at t=0, 60, 120, 180 minutes and 15 minutes prior to the end of hemodialysis (at a reduced pump speed with blood flow 50-100ml/min) and 60 minutes post-hemodialysis. A 24 hour urine will be collected in all participants except those receiving hemodialysis without any residual urine output. Dialysate samples will be collected at 1,2,3 hours during hemodialysis and at the end of hemodialysis. Blood samples will also be collected at 24 and 48 hours. Plasma, urine and dialysis cannabinoids (THC, CBD and their metabolites) will be quantified using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult age>25 years
- •estimated glomerular filtration rate (eGFR)>60ml/min/1.73m2 or eGFR<60ml/min/1.73m2 by the CKD Epidemiology Collaboration equation including in-center hemodialysis at least 2x weekly for a minimum of 3 hours per treatment via a tunnelled catheter treated >90 days
- •agree to take the medication as directed in the study
- •provides informed consent
排除标准
- •body mass index <20 or >35kg/m2
- •physical dependence on any drug other than caffeine or nicotine
- •history of clinically significant adverse event associated with cannabis intoxication
- •history of psychosis or mania or any active major psychiatric disorder
- •recent (within 30 days) use of any cannabinoid (natural or synthetic) identified by self-report or urine drug screen for cannabinoids
- •taking any medication with known interactions with THC or CBD via cytochrome P450 (CYP) CYP2C9, CYP2C19 and CYP4A6 or CYP2D4 (e.g. anti-epileptic drugs, calcineurin inhibitors, anti-fungal)
- •evidence of liver dysfunction (ALT less than 3 times upper limit of normal, bilirubin below upper limit of normal, international normalized ratio<1.5)
- •pregnant or breastfeeding women
- •change in ideal body weight or dry weight in the last 4 weeks
- •intradialytic hypotension (systolic blood pressure<90mmHg) requiring an intervention in the previous 4 weeks
研究组 & 干预措施
THC/CBD
Oral THC 0.1mg/kg and CBD 2.5mg/kg
干预措施: Tetrahydrocannabinol-Cannabidiol Combination (Drug)
结局指标
主要结局
Tetrahydrocannabinol and its metabolites renal clearance
时间窗: 48 hours
Renal clearance
Tetrahydrocannabinol and its metabolites maximum concentration (Cmax)
时间窗: 48 hours
Maximum concentration (Cmax)
Cannabidiol and its metabolites maximum concentration (Cmax)
时间窗: 48 hours
Maximum concentration (Cmax)
Cannabidiol and its metabolites renal clearance
时间窗: 48 hours
Renal clearance
Tetrahydrocannabinol and its metabolites area under the curve
时间窗: 48 hours
Area under the curve
Cannabidiol and its metabolites dialytic clearance
时间窗: 48 hours
Dialytic clearance
Other cannabinoids and their metabolites last detection time
时间窗: 48 hours
Last detection time
Tetrahydrocannabinol and its metabolites time to Cmax
时间窗: 48 hours
Time to Cmax
Tetrahydrocannabinol and its metabolites last detection time
时间窗: 48 hours
Last detection time
Tetrahydrocannabinol and its metabolites dialytic clearance
时间窗: 48 hours
Dialytic clearance
Cannabidiol and its metabolites time to Cmax
时间窗: 48 hours
Time to Cmax
Cannabidiol and its metabolites last detection time
时间窗: 48 hours
Last detection time
Other cannabinoids and their metabolites maximum concentration (Cmax)
时间窗: 48 hours
Maximum concentration (Cmax)
Other cannabinoids and their metabolites area under the curve
时间窗: 48 hours
Area under the curve
Other cannabinoids and their metabolites renal clearance
时间窗: 48 hours
Renal clearance
Cannabidiol and its metabolites area under the curve
时间窗: 48 hours
Area under the curve
Other cannabinoids and their metabolites time to Cmax
时间窗: 48 hours
Time to Cmax
Other cannabinoids and their metabolites dialytic clearance
时间窗: 48 hours
Dialytic clearance
次要结局
- Blood pressure(48 hours)
- Heart rate(48 hours)
- Adverse events(48 hours)