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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL201 in subjects with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNL201 low dose | Experimental |
| |
| DNL201 high dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNL201 | Drug | Oral repeating dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Randomization to Day 42 | |
| Number of Subjects with laboratory test abnormalities | Randomization to Day 42 | |
| Number of Subjects with vital sign abnormalities | Randomization to Day 42 | |
| Number of Subjects with electrocardiogram (ECG) abnormalities | Randomization to Day 42 | |
| Number of Subjects with clinically significant neurological examination abnormalities | Randomization to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL201 | Randomization to Day 28 | |
| Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL201 | Randomization to Day 28 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site(s) | Long Beach | California | 90808 | United States | ||
| Clinical Site(s) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40770658 | Derived | Maloney MT, Wang X, Ghosh R, Andrews SV, Maciuca R, Masoud ST, Agam M, Caprioli RM, Astarita G, Bondar VV, Chen J, Chiu CL, Davis SS, Ho AC, Nguyen HN, Propson NE, Reyzer ML, Davis OB, Deen MC, Zhu S, Di Paolo G, Vocadlo DJ, Estrada AA, de Vicente J, Lewcock JW, Arguello A, Suh JH, Huntwork-Rodriguez S, Henry AG. LRRK2 kinase activity regulates Parkinson's disease-relevant lipids at the lysosome. Mol Neurodegener. 2025 Aug 6;20(1):89. doi: 10.1186/s13024-025-00880-7. | |
| 40680102 |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C587728 | 2-methyl-2-(3-methyl-4-((4-(methylamino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)-1H-pyrazol-1-yl)propanenitrile |
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| Placebo |
| Drug |
Oral repeating dose |
|
| Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL201 | Randomization to Day 28 |
| Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL201 | Randomization to Day 28 |
| Pharmacokinetic measure of CSF concentrations of DNL201 | Randomization to Day 28 |
| Pharmacodynamic measure of pS935 in whole blood and/or PBMCs | Randomization to Day 28 |
| Pharmacodynamic measure of pRab10 in PBMCs | Randomization to Day 28 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Clinical Site(s) | Miami | Florida | 33143 | United States |
| Clinical Site(s) | Orlando | Florida | 32806 | United States |
| Clinical Site(s) | Farmington Hills | Michigan | 48334 | United States |
| Clinical Site(s) | Philadelphia | Pennsylvania | 19104 | United States |
| Clinical Site(s) | Spokane | Washington | 99202 | United States |
| Derived |
| Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18. |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |