NCT03462043撤回3 期
A Pivotal, Open-Label, Randomized, Crossover Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion Versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Bioavailability
研究概览
简要总结
This study will assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.
详细描述
This study will be an open-label, randomized, crossover study to assess the relative bioavailability of s.c. infused ND0612 versus jejunally infused CLES in patients with advanced PD.
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
- None
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
- •Patients with Advanced PD treated with LD/CD at a dose of at least 800 mg LD
- •Female patients must have a negative pregnancy test at screening and at admission.
- •Patients must have a body mass index (BMI) within the range of 18.5 - 35 kg/m2, where BMI = body weight (kg) / height (m2) at screening.
- •Must be willing and able to communicate and participate in the whole study.
- •Must provide written informed consent.
- •Must agree to use an adequate method of contraception (per local independent ethics committee requirements).
- •Area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration
排除标准
- •Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the patient unsuitable for study entry or potentially unable to complete all aspects of the study.
- •Positive serum serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) at the screening visit.
- •Patients with a history of drug abuse or alcoholism within the past 12 months prior to screening or positive drugs of abuse or alcohol test result at the screening visit and/or on admission.
- •Clinically significant electrocardiogram (ECG) rhythm abnormalities.
- •Renal or liver dysfunction that may alter drug metabolism including: serum creatinine >1.5 mg/dL, serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN), total serum bilirubin >2.5 mg/dL.
- •Psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study, including dementia, or patients who are considered to be violent or at suicidal risk by the Investigator.
- •Blood loss of greater than 500 mL within the previous 3 months prior to first dosing.
- •use of any medication from the prohibited concomitant therapies
研究组 & 干预措施
Sequence A
Active Comparator
干预措施: CLES (Combination Product)
Sequence A
Active Comparator
干预措施: ND0612 (Combination Product)
Sequence B
Active Comparator
干预措施: ND0612 (Combination Product)
Sequence B
Active Comparator
干预措施: CLES (Combination Product)
Sequence C
Active Comparator
干预措施: CLES (Combination Product)
Sequence D
Active Comparator
干预措施: CLES (Combination Product)
Sequence D
Active Comparator
干预措施: ND0612 (Combination Product)
Sequence C
Active Comparator
干预措施: ND0612 (Combination Product)
结局指标
主要结局
Bioavailability
时间窗: 6-7 days
To assess relative bioavailability of levodopa (LD) administered as ND0612, infused subcutaneously (s.c.), versus LD administered as carbidopa-levodopa enteral suspension (CLES)
次要结局
未报告次要终点
研究者
研究点 (2)
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