A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To investigate the safety and tolerability of Cogane™ oral solution
研究概览
简要总结
Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals with Cogane (pharmacokinetics) between these two groups.
It is expected that the study will prove that Cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A
干预措施: Cogane™ (PYM50028) (Drug)
Cohort B
干预措施: Cogane™ (PYM50028) (Drug)
Cohort C
干预措施: Cogane™ (PYM50028) (Drug)
Cohort D (Optional)
干预措施: Cogane™ (PYM50028) (Drug)
结局指标
主要结局
To investigate the safety and tolerability of Cogane™ oral solution
时间窗: Throughout 28 day dosing period
次要结局
- To investigate the pharmacokinetic profile of Cogane™ and its metabolites(Throughout 28 day dosing period)