This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of opicapone when administered orally once daily for 14 days as adjunctive therapy to carbidopa/levodopa in subjects with Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
catechol-O-methyltransferase (COMT) inhibitor
Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor
Neurocrine Clinical Site
Glendale, California, United States
Neurocrine Clinical Site
Long Beach, California, United States
Neurocrine Clinical Site
Farmington Hills, Michigan, United States
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-24)
Area under the plasma concentration versus time curve from 0 to 24 hours for analytes with quantifiable concentrations at 24 hours postdose
Time frame: up to 19 days
Pharmacokinetic evaluation of opicapone and its metabolites: area under the curve (AUC 0-tlast)
Area under the plasma concentration versus time curve from 0 hour to the time of the last measurable concentration for analytes below the limit of quantification at 24 hours postdose
Time frame: up to 19 days
Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax)
Maximum plasma concentration
Time frame: up to 19 days
Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax)
Time to maximum plasma concentration
Time frame: up to 19 days
Pharmacokinetic evaluation of levodopa following administration of opicapone: area under the curve (AUC 0-tlast)
Area under the plasma concentration versus time curve from 0 hours to time before next levodopa dose
Time frame: up to 15 days
Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax)
Maximum plasma concentration
Time frame: up to 15 days
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
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Number of participants with reported adverse events after study treatment.
Time frame: up to 19 days
Pharmacodynamic evaluation of opicapone on S-COMT activity
Maximum inhibition of S-COMT activity.
Time frame: up to 19 days