A Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax
研究概览
简要总结
The purpose of this study in healthy adult males is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594.
The purpose of this study in patients with Parkinson's disease is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of KDT-3594 will also be investigated.
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
- Single (Participant)
盲法说明
Healthy volunteer part -Multiple dose: Participant, Healthy volunteer part -Single dose and Patient part: No Masking
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer part
- •Healthy Japanese males aged 20 to 35 years, inclusive
- •Patient part
- •Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
- •Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
- •Male patients with Parkinson's disease aged 20 to 74 years inclusive, post-menopausal female patients with Parkinson's disease aged 50 to 74 years inclusive
排除标准
- •Healthy volunteer part
- •Subjects with any abnormal findings in physical examination vital signs, 12-lead ECG, clinical laboratory tests, ophthalmic examinations and electroencephalography
- •Patient part
- •Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
- •Healthy volunteer part and patient part
- •Subjects who do not agree to avoid dangerous works such as driving, mechanical operation and high-place work until completion of the follow-up examination
研究组 & 干预措施
Healthy volunteer part -Single dose
Single oral dose of KDT-3594
干预措施: KDT-3594 (Drug)
Healthy volunteer part -Multiple dose
Multiple oral doses of KDT-3594
干预措施: KDT-3594 (Drug)
Healthy volunteer part -Placebo
Multiple oral doses of Placebo
干预措施: Placebo (Drug)
Patient part -Single dose
Single oral dose of KDT-3594
干预措施: KDT-3594 (Drug)
Patient part -Multiple dose
Multiple oral doses of KDT-3594
干预措施: KDT-3594 (Drug)
结局指标
主要结局
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: Cmax
时间窗: Up to 336 hours after last administration
Plasma pharmacokinetic parameter of KDT-3594 and main metabolites: AUC
时间窗: Up to 336 hours after last administration
Occurrence of adverse events
时间窗: Up to 15 days after last administration
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS) score (Only patient part)(Up to 336 hours after last administration)