The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by a continuous subcutaneous infusion in subjects with Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
29
ABBV-951 administered by subcutaneous infusion.
Glendale Adventist Medical Ctr /ID# 166512
Glendale, California, United States
Bioclinica Research - Orlando /ID# 169687
Orlando, Florida, United States
Acpru /Id# 154976
Grayslake, Illinois, United States
University of Kentucky Chandler Medical Center /ID# 169086
Lexington, Kentucky, United States
Maximum Observed Plasma Concentration (Cmax) of Levodopa
Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.
Time frame: Hour 0-24
Time to maximum observed plasma concentration (Tmax) of Levodopa
Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.
Time frame: Hour 0-24
Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa
Area under the plasma concentration-time curve following a single infusion of ABBV-951.
Time frame: Hour 0-24
Adverse Events
Number of participants reporting adverse events
Time frame: 24 hours
Terminal phase elimination rate constant (β)
Apparent terminal phase elimination rate constant (β or Beta)
Time frame: Up to 72 hours
Terminal phase elimination half-life (T1/2)
Terminal phase elimination half-life (t1/2) will be assessed.
Time frame: Up to 72 hours
Corrected QT (QTc) Interval
QT interval adjusted for heart rate.
Time frame: Up to 76 hours
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Parexel Baltimore /ID# 169255
Baltimore, Maryland, United States
QUEST Research Institute /ID# 166035
Farmington Hills, Michigan, United States
Carolina Phase I, LLC /ID# 166034
Raleigh, North Carolina, United States