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This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study conducted in three parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNL201 | Experimental | Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days) |
|
| Placebo | Placebo Comparator | Part 1: Single-ascending dose cohorts; Part 2: Multiple-ascending dose cohorts (10 days); Part 3: Additional multiple-dose cohort (10 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNL201 | Drug | Oral dose(s) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), and discontinuations due to TEAEs | Up to 20 days | |
| PK parameter: Maximum observed concentration (Cmax) of DNL201 in plasma | Up to 10 days | |
| PK parameter: Time to maximum observed concentration (Tmax) of DNL201 in plasma | Up to 10 days | |
| PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL201 in plasma (single dosing only) | Up to 10 days | |
| PK parameter: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of DNL201 in plasma | Up to 10 days | |
| PK parameter: The area under the concentration-time curve over a dosing interval (AUC0-Ï„) of DNL201 in plasma (multiple dosing only) | Up to 10 days | |
| PK parameter: Apparent terminal elimination half-life (t1/2) of DNL201 in plasma | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of DNL201 in cerebrospinal fluid (CSF) (following selected single and multiple doses) | Up to 10 days | |
| The pharmacodynamics of DNL201 in whole blood as measured by the percent change from baseline in pS935 | Up to 10 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danna Jennings, MD | Denali Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site(s) | Dallas | Texas | 05247 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40680102 | 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. |
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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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| Drug |
Oral dose(s) |
|