An Open-label, Multi-centre, Single-dose Clinical Trial to Assess the Pharmacokinetic (PK) Properties and Tolerability of a Single Oromucosal Dose of 6 Sprays of Sativex® in Patients With Advanced Cancer Currently on Background Step III Opioid Therapy
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Pharmacokinetic endpoints of the analyte delta 9-tetrahydrocannabinol (THC).
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy.
详细描述
This is an open-label, multiple-centre, single dose clinical trial to assess the PK of a single oromucosal dose of Sativex in subjects with advanced cancer who are currently on background Step III opioid therapy.
A minimum of 25 subjects ≥18 years with advanced cancer will be needed for the assessment of the primary objective of the trial. The Screening Visit (Visit 1) will be performed within -10 to -2 days prior to dosing. For the Screening Visit, subjects will attend on an outpatient basis.
Subjects will be checked into the clinical research facility on Day -1 and will be confined to the clinical research facility for the Inpatient/Treatment Period (Day -1 to Day 3) (Visit 2). Subjects will be administered a single oromucosal dose of Sativex on Day 1 (time [t]=0). Fourteen PK blood samples will be taken from Day 1 to Day 3 during Visit 2: one predose sample and 13 postdose samples at the following time points after dosing: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours postdose.
Subjects will be discharged from the clinical research facility after the 48-hour PK blood sample has been taken and final safety assessments are completed. Subjects who discontinue from the trial prior to the completion of the PK blood draws will undergo the safety evaluations scheduled for Day 3.
The Safety Follow-up Call (Visit 3) will be made 7 (+2) days after dosing on Day 1. Subjects with any new adverse events (AEs) or clinical laboratory abnormalities will be asked to return for safety follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sativex
Sativex will be administered by trained, clinical trial personnel, via a pump action oromucosal spray. Sativex will be administered as 2 actuations (sprays) under the tongue or inside the cheeks every 4 minutes until 6 sprays have been administered. Following the administration of the first and second set of 2 actuations, patients will be offered 50 mL water to drink; and following the final set of 2 actuations, 100 mL of water will be offered (i.e., a total of 200 mL water will be offered during the Sativex dosing). There must be a period of at least 2 minutes and no more than 3 minutes between Sativex administration and consumption of water. Patients will not be permitted their regular medication until 2 hours post dose of investigational medicinal product (IMP) to minimize any possible drug interactions.
干预措施: Sativex (Drug)
结局指标
主要结局
Pharmacokinetic endpoints of the analyte delta 9-tetrahydrocannabinol (THC).
时间窗: 0-48 hours post-dose
• Mean maximum plasma concentration (Cmax) of THC.
Pharmacokinetic endpoints of the analyte THC.
时间窗: 0-48 hours post-dose
• Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞)) of THC.
Pharmacokinetic endpoints of the analyte 11-hydroxy-delta 9-tetrahydrocannabinol (11-OH-THC).
时间窗: 0-48 hours post-dose
• Mean Cmax of 11-OH-THC.
Pharmacokinetic endpoints of the analyte CBD.
时间窗: 0-48 hours
• Mean AUC(0-∞) of CBD.
Pharmacokinetic endpoints of the analyte 6-OH-CBD.
时间窗: 0-48 hours.
• Mean AUC(0-∞) of 6-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-hydroxy-cannabidiol (7-OH-CBD).
时间窗: 0-48 hours
• Mean Cmax of 7-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-OH-CBD.
时间窗: 0-48 hours
• Mean AUC(0-∞) of 7-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-COOH-CBD.
时间窗: 0-48 hours
• Mean AUC(0-∞) of 7-COOH-CBD.
Pharmacokinetic endpoints of the analyte 11-OH-THC.
时间窗: 0-48 hours post-dose
• Mean AUC(0-∞) of 11-OH-THC.
Pharmacokinetic endpoints of the analyte cannabidiol (CBD).
时间窗: 0-48 hours
• Mean Cmax of CBD.
Pharmacokinetic endpoints of the analyte 11-carboxy-delta 9-tetrahydrocannabinol (11-COOH-THC).
时间窗: 0-48 hours post-dose
• Mean Cmax of 11-COOH-THC.
Pharmacokinetic endpoints of the analyte 11-COOH-THC.
时间窗: 0-48 hours post dose
• Mean AUC(0-∞) of 11-COOH-THC.
Pharmacokinetic endpoints of the analyte 6-hydroxy-cannabidiol (6-OH-CBD).
时间窗: 0-48 hours.
• Mean Cmax of 6-OH-CBD.
Pharmacokinetic endpoints of the analyte 7-carboxy-cannabidiol (7-COOH-CBD).
时间窗: 0-48 hours
• Mean Cmax of 7-COOH-CBD.
次要结局
- Pharmacokinetic endpoints of the analyte 11-COOH-THC.(0-48 hours post-dose)
- Pharmacokinetic endpoints of the analyte CBD.(0-48 hours post-dose)
- Pharmacokinetic endpoints of the analyte THC.(0-48 hours post-dose)
- Pharmacokinetic endpoints of the analyte 11-OH-THC.(0-48 hours post-dose)
- Pharmacokinetic endpoints of the analyte 6-OH-CBD.(0-48 hours post-dose)
- Pharmacokinetic endpoints of the analyte 7-OH-CBD.(0-48 hours post-dose)
- Pharmacokinetic endpoints of the analyte 7-COOH-CBD.(0-48 hours post-dose)
- The incidence of adverse events as a measure of subject safety.(From screening to follow-up (a maximum of 19 days).)
- The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline.(From screening to follow-up (a maximum of 19 days))
- The number of subjects with a clinically significant change in in 12-lead ECG (electrocardiogram) results, relative to pre-treatment baseline.(From screening to follow-up (a maximum of 19 days))
- The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline.(From screening to follow-up (a maximum of 19 days))
- The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline.(From screening to follow-up (a maximum of 19 days))