An Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-Dopa
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- AUC0-24 Hours of Ropinirole
研究概览
简要总结
Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 12 weeks of ropinirole implant treatment, and evaluate the side effects of this new formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provided informed consent
- •Meet diagnostic criteria for idiopathic Parkinson's Disease
- •On L-Dopa and oral ropinirole
- •If female of child-bearing potential, willing to practice contraception from time of informed consent to Follow-Up Visit
排除标准
- •Pregnant, breastfeeding, or planning to become pregnant
- •Active epilepsy within the past year
- •Severe dementia or cognitive impairment
- •Donated or lost > 400 mL of blood within 1 month prior to Screening
- •History of alcohol or substance use disorder within the prior 12 months
- •Recent episodes of moderate to severe dizziness or syncope
- •Definite or suspected hypersensitivity to ropinirole or ethylene vinyl acetate
- •Used any other investigational drug within 60 days or 5 half-lives prior to Screening, or plan to take any such drug any time during the study
研究组 & 干预措施
Cohort 1
Requip; One Ropinirole Implant
干预措施: Ropinirole oral product (Drug)
Cohort 1
Requip; One Ropinirole Implant
干预措施: Ropinirole Implant (Drug)
Cohort 2
Requip; Two Ropinirole Implants
干预措施: Ropinirole oral product (Drug)
Cohort 2
Requip; Two Ropinirole Implants
干预措施: Ropinirole Implant (Drug)
Cohort 3
Requip; Three Ropinirole Implants
干预措施: Ropinirole oral product (Drug)
Cohort 3
Requip; Three Ropinirole Implants
干预措施: Ropinirole Implant (Drug)
Cohort 4
Requip; Four Ropinirole Implants
干预措施: Ropinirole oral product (Drug)
Cohort 4
Requip; Four Ropinirole Implants
干预措施: Ropinirole Implant (Drug)
结局指标
主要结局
AUC0-24 Hours of Ropinirole
时间窗: 0-24 hours
Area under the plasma drug concentration-time curve of ropinirole
Total Number of Adverse Events Across Participants
时间窗: 0-12 weeks
Safety and tolerability of ropinirole implant(s) presented as the total number of adverse events experienced by the analysis population.
次要结局
- AUC0-24 Hours of N-despropyl Ropinirole(0-24 hours)
- Mean Change From Baseline of Awake Time "On"(Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12)
- AUC0-24 Hours of 7-hydroxy Ropinirole(0-24 hours)
- Mean Change From Baseline in MDS-UPDRS Total Score(Baseline and Weeks 4, 8 and 12)
- Mean Change From Baseline of Awake Time "Off"(Baseline and Weeks 1, 2, 3, 4, 6, 8, 10, 12)