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In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.
Design: single center, double-blind, randomized, placebo-controlled, crossover study.
Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.
Population: Eight (8) PD subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence A | Experimental | Period 1. ND0612; Period 2. Placebo |
|
| Treatment sequence B | Experimental | Period 1. Placebo; Period 2. ND0612 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa/carbidopa solution for SC administration | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and frequency of adverse events |
| up to 8 weeks |
| Withdrawal rate | Withdrawal rates and discontinuations due to adverse events | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC | LD PK profile after oral LD dosing administered with or without ND0612: | Up to 2 days |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
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| Placebo | Drug |
|
|
| 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 |
|---|---|
| D007980 | Levodopa |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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