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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Clinical Site(s)
Long Beach, California, United States
Clinical Site(s)
Aurora, Colorado, United States
Clinical Site(s)
Miami, Florida, United States
Clinical Site(s)
Orlando, Florida, United States
Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Randomization to Day 42
Number of Subjects with laboratory test abnormalities
Time frame: Randomization to Day 42
Number of Subjects with vital sign abnormalities
Time frame: Randomization to Day 42
Number of Subjects with electrocardiogram (ECG) abnormalities
Time frame: Randomization to Day 42
Number of Subjects with clinically significant neurological examination abnormalities
Time frame: Randomization to Day 42
Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL201
Time frame: Randomization to Day 28
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL201
Time frame: Randomization to Day 28
Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL201
Time frame: Randomization to Day 28
Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL201
Time frame: Randomization to Day 28
Pharmacokinetic measure of CSF concentrations of DNL201
Time frame: Randomization to Day 28
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Clinical Site(s)
Farmington Hills, Michigan, United States
Clinical Site(s)
Philadelphia, Pennsylvania, United States
Clinical Site(s)
Spokane, Washington, United States
Pharmacodynamic measure of pS935 in whole blood and/or PBMCs
Time frame: Randomization to Day 28
Pharmacodynamic measure of pRab10 in PBMCs
Time frame: Randomization to Day 28