An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 主要终点
- Variability in plasma levodopa concentration
研究概览
简要总结
The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.
详细描述
An open label, non randomized crossover phase 2 study to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients. The study will have a screening period followed by an overnight stay in clinic where Immediate release CD/LD (Sinemet) will be administered five times, approximately every three hours. At specified intervals, blood will be drawn for PK testing. On Days 2-7, subjects will be treated at home with AP CD/LD three times/day, approximately every five hours. Day 8 will be overnight stay in clinic for PK study. AP CD/LD 500mg TID will be dispensed to subjects with specified timelines for PK assessment. Each subject will return to clinic on day 15 for a safety followup visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •diagnosis of PD consistent with UK Brain Bank Criteria
- •Stable dose of levodopa/carbidopa IR for at least 4 weeks prior to entry; taking at least 4 doses of IR levodopa during waking hours, and total daily dose of at least 400mg prior to initial screening
- •Stable on all anti-PD medications for 30 days prior to screening. COMT inhibitors are held prior to PK studies on day 1 through day 8
排除标准
- •Atypical or secondary parkinsonism
- •clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator
- •severe dyskinesia as assessed by PI
- •significant cognitive impairment
- •Clinically significant psychiatric illness in opinion of PI
- •history of small bowel or gastric surgery (including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, frequent nausea or emesis regardless of etiology, and symptomatic gastroparesis.
- •History of GI pathology of clinical significance as determined by PI
- •Allergy to study drug or Yellow Dye #5 (tartrazine)
- •Unable to swallow large pills
- •Active GERD and regular use of PPIs
- •Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception
研究组 & 干预措施
Sinemet
Controlled Release 25/100
干预措施: Sinemet CR 25Mg-100Mg Extended-Release Tablet (Drug)
AP CD/LD
干预措施: Accordion Pill Carbidopa/Levodopa (Drug)
结局指标
主要结局
Variability in plasma levodopa concentration
时间窗: Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8.
as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD
次要结局
- Variability in plasma levodopa concentration(Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8.)