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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opicapone once daily with Carbidopa/Levodopa | Experimental | Opicapone administered once daily for 14 days; carbidopa/levodopa administered at set frequency on Study Days 1, 2 & 15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opicapone | Drug | catechol-O-methyltransferase (COMT) inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | up to 19 days |
| Pharmacokinetic evaluation of opicapone and its metabolites: Maximum plasma concentration (Cmax) | Maximum plasma concentration | up to 19 days |
| Pharmacokinetic evaluation of opicapone and its metabolites: Time to maximum plasma concentration (tmax) | Time to maximum plasma concentration | 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 | up to 15 days |
| Pharmacokinetic evaluation of levodopa following administration of opicapone: maximum plasma concentration (cmax) | Maximum plasma concentration | up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (safety and tolerability) | Number of participants with reported adverse events after study treatment. | up to 19 days |
| Pharmacodynamic evaluation of opicapone on S-COMT activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Glendale | California | 91206 | United States | ||
| Neurocrine Clinical Site |
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| Carbidopa Levodopa | Drug | Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor |
|
|
Maximum inhibition of S-COMT activity.
| up to 19 days |
| Long Beach |
| California |
| 90806 |
| United States |
| Neurocrine Clinical Site | Farmington Hills | Michigan | 48334 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C549349 | opicapone |
| C009265 | carbidopa, levodopa drug combination |
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