A study that compares the extent to which apomorphine becomes available in the body after taking either an investigational drug containing apomorphine or apomorphine that is injected under the skin in people with PD complicated by "OFF" episodes.
This multi-center study will aim to evaluate the pharmacokinetics (PK) and comparative bioavailability of a single dose of APL-130277 sublingual thin film with subcutaneous (s.c.) APO-go® and s.c. APOKYN® in subjects with Parkinson's disease (PD). The dose of APOKYN® (≤ 5 mg) will be based on the subjects' current prescribed dose. The study is designed as an open-label, randomized, three-way crossover. Subjects will receive all three treatment arms with a minimum 1-day wash-out between each visit (excluding the screening visit) and will be randomly assigned to one of the six sequences
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
APL-130277 sublingual thin film
Subcutaneous APO-go
Subcutaneous APOKYN
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Parkinson's Disese Treatment Center of SW Florida
Port Charlotte, Florida, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Maximum Observed Plasma Concentration (Cmax)
Dose normalized maximum observed plasma concentration (Cmax)
Time frame: Day 1
Observed Time of the Maximum Concentration (Tmax)
Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.
Time frame: Day 1
Area Under the Concentration- Time Curve (AUC Last)
area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.
Time frame: Day 1
Area Under the Concentration- Time Curve (AUC Inf)
area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.
Time frame: Day 1
Mean Residence Time (MRT)
Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.
Time frame: Day 1
Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax
Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.
Time frame: Day 1
Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)
Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.
Time frame: Day 1
Apparent Volume of Distribution After Non-intravenous Administration (V/F)
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Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf \* λz).
Time frame: Day 1
Terminal-phase Half-life (t½)
Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.
Time frame: Day 1
Terminal-phase Rate Constant ( λz)
Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.
Time frame: Day 1
Metabolite/Parent (M/P) Drug Concentration Ratio -AUC Last
Metabolite (apomorphine sulfate) to Parent exposure ratio, AUClast, corrected for molecular weight differences.
Time frame: Day 1