A Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 11
- 主要终点
- Levodopa Cmax Following First Dose on Day 1
研究概览
简要总结
Primary Objective:
To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).
Secondary Objectives:
To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.
To compare the efficacy of IPX203 with IR CD-LD following multiple doses.
To evaluate the safety of IPX203.
详细描述
IPX203 is an investigational product containing CD-LD.
IPX203-B16-01 Study Design:
A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study.
Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.
The study duration will be approximately 8 weeks, including the screening period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic PD at age ≥ 40 years who are being chronically treated with stable regimens of CD-LD but experiencing motor complications.
- •Hoehn and Yahr Stages 2, 3, or 4
- •Montreal Cognitive Assessment (MoCA) score ≥ 24 at Screening Visit in "on" state.
- •For the 4 weeks prior to the Screening, the subject experiences daily "wearing-off" episodes with periods of bradykinesia and rigidity and experiences an "off" state upon awakening on most mornings by history.
- •Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1
- •Typically experiences an "on" response with the first dose of IR CD-LD of the day (by subject history).
- •By history, efficacy of the first morning dose of IR CD-LD lasts less than 4 hours
排除标准
- •History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or proximal small-bowel resection.
- •Liver enzyme values ≥ 2.5 x the upper limit of normal; or history of severe hepatic impairment.
- •History of drug or alcohol abuse within the 12 months prior to Screening.
- •Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: any doses of a controlled-release (CR) LD apart from a single daily bedtime dose or any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo). Received within 4 weeks of Visit 1 or planning to take during participation in the clinical study: nonselective monoamine oxidase (MAO) inhibitors, apomorphine, or dopaminergic blocking agents including antiemetics.
- •History of psychosis within the past 10 years.
- •Treatment with any dopamine antagonist antipsychotics for the purposes of psychosis or bipolar disorder within the last 2 years.
- •Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD Diary.
研究组 & 干预措施
IPX203 then Sinemet
Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
干预措施: Sinemet (Drug)
IPX203 then Sinemet
Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
干预措施: IPX203 (Drug)
Sinemet then IPX203
Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
干预措施: Sinemet (Drug)
Sinemet then IPX203
Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours.
干预措施: IPX203 (Drug)
结局指标
主要结局
Levodopa Cmax Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa Tmax Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa t1/2 Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa AUCt Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa AUCinf Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa Cmax Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa Tmax Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa t1/2 Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa AUCt Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa AUCinf Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
时间窗: Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Levodopa Cmax Following First Dose on Day 15
时间窗: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Levodopa Tmax Following First Dose on Day 15
时间窗: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Levodopa AUCtau Following First Dose on Day 15
时间窗: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Carbidopa Cmax Following First Dose on Day 15
时间窗: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Carbidopa Tmax Following First Dose on Day 15
时间窗: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Carbidopa AUCtau Following First Dose on Day 15
时间窗: Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
次要结局
未报告次要终点