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This is a study to understand if taking VTX3232 is safe in participants diagnosed with early stage idiopathic Parkinson's Disease (PD). Approximately 10 patients will take VTX3232 Dose A.
The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 7-day Pre-Baseline Period, a 28-day Open Label Treatment period (a participant receives active Dose A), and a 14-day Follow-Up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VTX3232 Dose A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VTX3232 | Drug | Dose A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) / Serious Adverse Event (SAE) Incidence Rate and Severity through study completion | Incidence of AEs and SAEs | Day 1 of treatment period through study completion, up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of VTX3232 in plasma and Cerebrospinal Fluid (CSF) at Day 28 | Concentration of VTX3232 in plasma and CSF through 28 days of study treatment | Day 1 of treatment period to Day 28 of treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Snehal Naik, PhD | Zomagen Biosciences Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Site #840001 | New Haven | Connecticut | 06510 | United States |
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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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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |