Parkinson Disease Clinical Trial
Official title:
A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's Disease
Verified date | January 2020 |
Source | Denali Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | December 6, 2019 |
Est. primary completion date | December 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 80 Years |
Eligibility |
Key Inclusion Criteria: - Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive - Clinical diagnosis of Parkinson's disease meeting UK Brain Bank criteria and H&Y Stage I, II, or III. - sPD subgroup without a LRRK2 mutation; PD LRRK2 subgroup with LRRK2 mutation - Screening dopamine transporter (DAT) SPECT scan with a DAT deficit consistent with Parkinson's disease - Able to hold Parkinson's disease medications 8 hours (overnight) prior to specific study assessments Key Exclusion Criteria: - Any history of clinically significant asthma, chronic obstructive pulmonary disease, or emphysema within 5 years of screening, or other clinically significant pulmonary disease within 6 months of screening - Abnormal Vitals including Respiratory Rate, Body Temperature, and Blood Pressure - Pulmonary Function Tests (PFTs) (FVC <60% predicted, FEV1 <50% predicted, FEV1:FVC ratio <0.6, DLCO <70% predicted) - Clinically significant neurologic disorder other than Parkinson's disease, including history of stroke, cognitive impairment, seizure within 5 years of screening, or head trauma with loss of consciousness within 6 months of screening - Montreal Cognitive Assessment (MoCA) score of <24 at screening |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Site(s) | Aurora | Colorado |
United States | Clinical Site(s) | Farmington Hills | Michigan |
United States | Clinical Site(s) | Long Beach | California |
United States | Clinical Site(s) | Miami | Florida |
United States | Clinical Site(s) | Orlando | Florida |
United States | Clinical Site(s) | Philadelphia | Pennsylvania |
United States | Clinical Site(s) | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Denali Therapeutics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Randomization to Day 42 | ||
Primary | Number of Subjects with laboratory test abnormalities | Randomization to Day 42 | ||
Primary | Number of Subjects with vital sign abnormalities | Randomization to Day 42 | ||
Primary | Number of Subjects with electrocardiogram (ECG) abnormalities | Randomization to Day 42 | ||
Primary | Number of Subjects with clinically significant neurological examination abnormalities | Randomization to Day 42 | ||
Secondary | Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL201 | Randomization to Day 28 | ||
Secondary | Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL201 | Randomization to Day 28 | ||
Secondary | Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL201 | Randomization to Day 28 | ||
Secondary | Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL201 | Randomization to Day 28 | ||
Secondary | Pharmacokinetic measure of CSF concentrations of DNL201 | Randomization to Day 28 | ||
Secondary | Pharmacodynamic measure of pS935 in whole blood and/or PBMCs | Randomization to Day 28 | ||
Secondary | Pharmacodynamic measure of pRab10 in PBMCs | Randomization to Day 28 |
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