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The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ND0611 dose 1, ND0611 dose 2, placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND0611 | Drug | Continuous delivery of ND0611 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Safety and tolerability:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Pharmacokinetic profile of plasma LD and CD:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ND0611 |
| Drug |
Solution of ND0611 delivered continuously |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |