NCT01103011已完成1 期
A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611
适应症
干预措施
相关药物
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
- Safety and tolerability
研究概览
简要总结
The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasian males between 18 and 50 years (inclusive) of age
- •Normal body weight
- •Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests
- •Subjects must be able to adhere to the protocol requirements
- •Subjects must provide written informed consent to participate in the study.
- •Haemoglobin level >12.5 mg /dl
排除标准
- •History of significant psychiatric disorder, neurological diseases or sleep disorders
- •History of significant systemic diseases, by medical history or tests performed during screening examinations
- •Clinically significant laboratory tests at screening
- •History of drug or alcohol abuse.
- •Allergy to levodopa, carbidopa or any inactive component of the test formulation.
- •Subjects with dark skin
- •Subjects with skin diseases or neoplasms
- •Subjects with narrow-angle glaucoma
- •Subjects with significant allergic response to other drugs.
- •Subject with known atopic disorders
- •Known allergy or hypersensitivity to adhesive tapes.
- •Use of any prescription or over-the-counter (OTC) medications
- •Subjects who donated blood or received blood, in the last 3 months
- •Participation in another clinical trial in the last 30 days
- •Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures
研究组 & 干预措施
ND0611 dose 1, ND0611 dose 2, placebo
Experimental
干预措施: ND0611 (Drug)
结局指标
主要结局
Safety and tolerability
Safety and tolerability: * Adverse event reporting * Discontinuation of the treatment due to adverse event
次要结局
- Pharmacokinetics
研究者
研究点 (1)
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