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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Continuous Subcutaneous Infusion (CSCI)
University of Colorado Hospital /ID# 229974
Aurora, Colorado, United States
Georgetown University Hospital /ID# 230224
Washington D.C., District of Columbia, United States
Rush University Medical Center /ID# 229983
Chicago, Illinois, United States
Carolina Phase 1, LLC /ID# 239836
Raleigh, North Carolina, United States
The Movement Disorder Clinic of Oklahoma /ID# 238610
Tulsa, Oklahoma, United States
Vanderbilt University Medical Center /ID# 230255
Nashville, Tennessee, United States
Parkinson Disease Movement Disorders Clinic /ID# 245791
Austin, Texas, United States
Texas Movement Disorder Specialists /ID# 238607
Georgetown, Texas, United States
Baylor College of Medicine - Baylor Medical Center /ID# 239631
Houston, Texas, United States
University of Utah Health Care /ID# 241219
Salt Lake City, Utah, United States
Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)
Maximum observed plasma concentration (Cmax) of Levodopa (LD).
Time frame: Up to 8 Days
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.
Time frame: Up to 8 Days
Minimum Observed Plasma Concentration (Cmin) of LD
Minimum observed plasma concentration (Cmin) of LD.
Time frame: Up to 8 Days
Degree of Fluctuation (DFL) of LD
DFL = (Cmax-Cmin)/(average plasma concentration).
Time frame: Up to 8 Days
Swing of LD
Swing = (Cmax-Cmin)/Cmin.
Time frame: Up to 8 Days
Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)
Maximum observed plasma concentration (Cmax) of CD.
Time frame: Up to 8 Days
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD
Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.
Time frame: Up to 8 Days
Minimum Observed Plasma Concentration (Cmin) of CD
Minimum observed plasma concentration (Cmin) of CD.
Time frame: Up to 8 Days
Degree of Fluctuation (DFL) of CD
DFL = (Cmax-Cmin)/(average plasma concentration).
Time frame: Up to 8 Days
Swing of CD
Swing = (Cmax-Cmin)/Cmin.
Time frame: Up to 8 Days
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