Pharmacokinetic and Pharmacodynamic Evaluation of 3 Standard Formulations of Δ9-THC in Healthy Volunteers and Post-chemotherapy Patients in Colombia
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Pharmacokinetic assessment profile of THC formulations
研究概览
简要总结
Study based on the pharmacokinetic, pharmacodynamic, safety and stability evaluation of 3 standardized formulations of THC, to be used in healthy volunteers and post-chemotherapy patients as an adjuvant in the symptomatic treatment of the latter in discomfort associated with cancer treatment, with the aim of possible new therapeutic entities.
详细描述
This evaluation project of 3 oral formulations of Δ9-THC will be carried out in two phases: Phase I evaluation of bioequivalences in healthy subjects and Phase II evaluation of safety and effectiveness comparing with the reference product (Dronabinol 5mg/mL), formulations derived from cannabis for the management of nausea, vomiting post chemotherapy and exploratory in cancer pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for healthy volunteers
- •In order to be eligible to be admitted to this study, healthy volunteers must:
- •Being a person > 18 years of age
- •Have the ability to understand the requirements of the study and be willing to give written informed consent
- •Agree to abide by study restrictions and return for required evaluations.
- •Signed written informed consent.
- •Inclusion criteria for patients
- •In order to be eligible to be admitted to this study, patients must:
- •Being a person > 18 years of age
- •Be a patient with documented chemotherapy treatment.
- •Patients with any of the following cancers: breast, prostate, lung, colorectal, cervical, gastric and liver cancer.
- •Have a life expectancy >1 year
- •Have the ability to understand the requirements of the study and be willing to give written informed consent
- •Agree to abide by study restrictions and return for required evaluations
排除标准
- •Exclusion criteria for healthy volunteers
- •To be eligible to be admitted to this study, the participant and/or patient must not:
- •Recreational or medicinal use of cannabinoids in the last 3 months.
- •Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
- •Hypersensitivity to any component of the investigational product.
- •Patients prescribed dronabinol between arrival and prior to screening/randomization
- •Pregnancy or lactation
- •Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms
- •Opioid hypersensitivity
- •Patients who have undergone concomitant immunotherapy with chemotherapy
- •Cannabinoid Hyperemesis Syndrome (CHS).
- •Exclusion criteria for patients
- •To be eligible to be admitted to this study, the participant and/or patient must not:
- •Patients who are null by mouth (NPO) at the time of randomization or who are expected to be NPO within the next 48 hours
- •Patients who have received or are expected to receive neuraxial/locoregional blocks for pain in the next 48 hours.
- •Recreational or medicinal use of cannabinoids in the last 3 months.
- •Uses of current medications such as: immunomodulators, antibiotics, corticosteroids
- •Hypersensitivity to any component of the investigational product.
- •Patients prescribed dronabinol between arrival and prior to screening/randomization
- •Pregnancy or lactation
- •Liver pathologies and/or CYP2A3, CYP2C9 and CYP2C19 polymorphisms
- •Opioid hypersensitivity
- •Patients who have undergone concomitant immunotherapy with chemotherapy
- •Cannabinoid Hyperemesis Syndrome (CHS). -
研究组 & 干预措施
Dronabinol 5mg/mL
Drug: Dronabinol (SYNDROS) Oral solution of SYNDROS (5 mg/mL)
干预措施: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator (Drug)
THC F1
Drug: THC Oral solution of THC (5 mg/mL)
干预措施: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator (Drug)
THC F2
Drug: THC:CBG Oral solution of THC (5 mg/mL) & CBG (5 mg/mL)
干预措施: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator (Drug)
THC F3
Drug: THC:CBC Oral solution of THC (5 mg/mL) & CBC (5 mg/mL)
干预措施: Pharmacokinetic and pharmacodynamic profile of THC oral formulations with Dronabinol as comparator (Drug)
结局指标
主要结局
Pharmacokinetic assessment profile of THC formulations
时间窗: 48 hours with a replicate 7 days after the first dose in healthy subjects and the same time but with successive doses in post-chemotherapy patients
Pharmacokinetics of THC by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) \[ Time Frame: 0 hours (pre-dose), as well as at 0.12, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose \]
Pharmacodynamic assessment profile of THC formulations: BPI
时间窗: Post-chemotherapy patients for at least 20 days with a daily report
Brief pain inventory (BPI); The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."
Pharmacodynamic assessment profile of THC formulations: DEQ
时间窗: 48 hours with a replicate of 7 days after the first dose in healthy subjects and on the other hand post-chemotherapy patients for at least 20 days with a daily report
Drug Effects Questionnaire (DEQ);is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: "Feel Drug", "Feel High", "Like Drug", and "Want More", "dislike the sensation", "any sensations", "feel a head rush", "like drug effect", "dislike any effects". To calculate the DEQ- 'Good Drug Effects'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome
No significant nausea in terms of the proportion of subjects with no significant nausea
时间窗: Post-chemotherapy patients for at least 20 days with a daily report
To investigate THC oral formulations in terms of the proportion of patients with no significant nausea (none or mild nausea) following initiation of oral formulations of THC (dronabinol) in post-chemotherapy patients
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(14 days for healthy subjects, 20 days for post-chemotherapy patients)
- Global Quality of Life (QoL) of the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire(at least 20 days for post-chemotherapy patients)