A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence and frequency of adverse events
研究概览
简要总结
In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.
详细描述
Design: single center, double-blind, randomized, placebo-controlled, crossover study.
Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.
Population: Eight (8) PD subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with idiopathic Parkinson's disease
- •Subjects must experience motor fluctuations associated with LD/CD dosing
- •Modified Hoehn and Yahr stage < 5
- •Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
- •Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
- •Subjects must be age 30 or older.
- •Subjects must be willing and able to give informed consent.
排除标准
- •Subjects with a clinically significant or unstable medical or surgical condition
- •Subjects with clinically significant psychiatric illness.
- •Pre-menopausal women, not using birth control method.
- •Subjects who have taken experimental medications within 60 days prior to baseline.
- •Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
研究组 & 干预措施
Treatment sequence A
Period 1. ND0612; Period 2. Placebo
干预措施: Levodopa/carbidopa solution for SC administration (Drug)
Treatment sequence A
Period 1. ND0612; Period 2. Placebo
干预措施: Placebo (Drug)
Treatment sequence B
Period 1. Placebo; Period 2. ND0612
干预措施: Levodopa/carbidopa solution for SC administration (Drug)
Treatment sequence B
Period 1. Placebo; Period 2. ND0612
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and frequency of adverse events
时间窗: up to 8 weeks
1. Incidence and frequency of adverse events 2. Adverse events reporting related to the ND0612 application, local safety score
Withdrawal rate
时间窗: 2 days
Withdrawal rates and discontinuations due to adverse events
次要结局
- LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC(Up to 2 days)