Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Degree of Fluctuation (DFL) of LD
研究概览
简要总结
Parkinson's disease (PD) is a neurological condition, which means it affects the brain. This study will evaluate how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen.
ABBV-951 is an investigational drug being developed for the treatment of PD. Study doctors randomly assign participants to 1 of 4 groups, called treatment arms. Each treatment arm receives ABBV-951 administered in a different order in the arm, high, flank and abdomen. Approximately 12 adult participants over 30 years with a diagnosis of PD will be enrolled in approximately 10 sites in the United States.
Participants will receive continuous (24hours/day) subcutaneous infusion of ABBV-951 for 2 consecutive days for each infusion site (arm, thigh, flank and abdomen), for a total duration of treatment up to 12 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will be confined at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Adverse events will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 idiopathic Parkinson's disease (PD) that is Levodopa-responsive.
- •Must be taking a minimum of 400 mg/day of levodopa equivalents (LE) and be judged by the investigator to have motor symptoms inadequately controlled by current therapy.
- •Must have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum daily average of 2.5 hours of "Off" time (with a minimum of 2 hours of "Off" time each day).
排除标准
- •History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
研究组 & 干预措施
Arm 1: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4).
干预措施: ABBV-951 (Drug)
Arm 2: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4).
干预措施: ABBV-951 (Drug)
Arm 3: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4).
干预措施: ABBV-951 (Drug)
Arm 4: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the flank (Period 1), thigh (Period 2), abdomen (Period 3) and arm (Period 4).
干预措施: ABBV-951 (Drug)
结局指标
主要结局
Degree of Fluctuation (DFL) of LD
时间窗: Up to 8 Days
DFL = (Cmax-Cmin)/(average plasma concentration).
Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)
时间窗: Up to 8 Days
Maximum observed plasma concentration (Cmax) of Levodopa (LD).
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD
时间窗: Up to 8 Days
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.
Minimum Observed Plasma Concentration (Cmin) of LD
时间窗: Up to 8 Days
Minimum observed plasma concentration (Cmin) of LD.
Swing of LD
时间窗: Up to 8 Days
Swing = (Cmax-Cmin)/Cmin.
Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)
时间窗: Up to 8 Days
Maximum observed plasma concentration (Cmax) of CD.
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD
时间窗: Up to 8 Days
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.
Minimum Observed Plasma Concentration (Cmin) of CD
时间窗: Up to 8 Days
Minimum observed plasma concentration (Cmin) of CD.
Degree of Fluctuation (DFL) of CD
时间窗: Up to 8 Days
DFL = (Cmax-Cmin)/(average plasma concentration).
Swing of CD
时间窗: Up to 8 Days
Swing = (Cmax-Cmin)/Cmin.
次要结局
未报告次要终点