The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL151 in subjects with Parkinson's disease.
This study was previously posted by Denali Therapeutics. In July, 2022, sponsorship of the trial was transferred to Biogen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
PPD Clinical Research Unit
Orlando, Florida, United States
Quest Research Institute
Farmington Hills, Michigan, United States
UZ Leuven
Leuven, Belgium
Centre for Human Drug Research
Leiden, South Holland, Netherlands
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 DNL151
Time frame: Randomization to Day 28
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151
Time frame: Randomization to Day 28
Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151
Time frame: Randomization to Day 28
Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151
Time frame: Randomization to Day 28
Pharmacokinetic measure of CSF concentrations of DNL151
Time frame: Randomization to Day 28
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QPS
Leeuwarden, Netherlands
Royal Liverpool University Hospital
Liverpool, United Kingdom
MAC Clinical Research
Manchester, United Kingdom
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, United Kingdom
Pharmacodynamic measure of pS935 in whole blood
Time frame: Randomization to Day 28
Pharmacodynamic measure of pRab10 in PBMCs
Time frame: Randomization to Day 28