A Double Blind, Randomized, Placebo-controlled, Two-part Study to Investigate the Pharmacokinetics, Followed by Efficacy and Safety of GWP42006 as add-on Therapy in Patients With Inadequately Controlled Focal Seizures.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Pharmacokinetic parameters of GWP42006 and metabolites: Cmax, Cmin, tmax, AUC(0-t), AUC(0-inf) and t1/2, in the presence of other AEDs.
研究概览
简要总结
To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo, in the presence of other antiepileptic drugs (AEDs).
详细描述
This is a double blind, randomized, placebo controlled, two-part study. Part A only will be described in this record.
Subjects who satisfy all inclusion and none of the exclusion criteria will begin a 14-day baseline observation period followed by a 14-day treatment period. Subjects will be required to attend six study visits. A follow-up phone call will take place four weeks after last dose.
Part A will enroll three groups of 10 subjects:
- Group 1 - subjects on inducer AEDs (and not on inhibitor AEDs)
- Group 2 - subjects on inhibitor AEDs (and not on inducer AEDs)
- Group 3 - subjects on AEDs that are neither inducers nor inhibitors.
In each of the three groups subjects will be randomized to receive, in a 4:1 ratio, GWP42006 400 mg twice daily or matching placebo. Pharmacokinetic (PK) profiles for GWP42006 and metabolites will be collected on the first and last day of treatment. Samples will also be collected 24h and 72h after the last day of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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
Group 1b
Matching placebo control for Group 1a.
干预措施: Placebo (Drug)
Group 1a
Subjects on inducer AEDs will administer GWP42006.
干预措施: GWP42006 (Drug)
Group 2a
Subjects on inhibitor AEDs will administer GWP42006.
干预措施: GWP42006 (Drug)
Group 3a
Subjects on AEDs that are neither inducers nor inhibitors will administer GWP42006.
干预措施: GWP42006 (Drug)
Group 2b
Matching placebo control for Group 2a.
干预措施: Placebo (Drug)
Group 3b
Matching placebo control for Group 3a.
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic parameters of GWP42006 and metabolites: Cmax, Cmin, tmax, AUC(0-t), AUC(0-inf) and t1/2, in the presence of other AEDs.
时间窗: Day 1 to Day 18
次要结局
- Safety and tolerability of GWP42006 (incidence of adverse events).(Day -14 to Day 43)
- The plasma concentration of concomitant AEDs.(Day 1 and Day 15)