Interventional, Open-label, Trial Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF28996 in Chinese Men and Women With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is Chinese, defined as having four Chinese grandparents being born in China.
- •The participant is diagnosed with idiopathic Parkinson's disease (consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD).
- •The participant's Modified Hoehn and Yahr score is ≥2 and ≤4 (in OFF) and ≤3 in the ON state.
- •The participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning OFF episodes causing clinically significant disability during the last 3 months prior to screening, as evaluated by the investigator.
排除标准
- •The participant has received oral or transdermal dopamine agonist treatment ≤4 weeks prior to screening.
- •The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation).
- •The participant has any other disorder for which the treatment takes priority over treatment of Parkinson's disease or is likely to interfere with trial treatment or impair treatment compliance.
- •The participant has received Traditional Chinese Medicine treatment ≤4 weeks prior to screening.
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Lu AF28996
Participants will receive oral doses of Lu AF28996 twice daily (BID) as add-on to the participant's usual PD treatment (levodopa and allowed PD medications) during the Up-titration treatment period, whereafter the participants will initiate down-titration of Lu AF28996.
干预措施: Lu AF28996 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 60 days
Area Under the Plasma Concentration-time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996
时间窗: Days 1, 21 or 31, and 41
Maximum Observed Plasma Concentration (Cmax) of Lu AF28996
时间窗: Days 1, 21 or 31, and 41
Time to Reach Cmax (Tmax) of Lu AF28996
时间窗: Days 1, 21 or 31, and 41
次要结局
未报告次要终点