Status:
COMPLETED
Study to Evaluate DNL151 in Subjects With Parkinson's Disease
Lead Sponsor:
Biogen
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This study was previously posted by Denali Therapeutics. In July, 2022, sponsorship of the trial was transferred to Biogen.
Eligibility Criteria
Inclusion
- Key
- 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.
- Able to hold Parkinson's disease medications 8 hours (overnight) prior to specific study assessments
- Key
Exclusion
- 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, Blood Pressure, and Pulse Rate
- 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 within 12 months of screening, 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
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04056689
Start Date
July 23 2019
End Date
December 2 2020
Last Update
April 18 2023
Active Locations (8)
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1
PPD Clinical Research Unit
Orlando, Florida, United States, 32806
2
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
3
UZ Leuven
Leuven, Belgium, 3000
4
Centre for Human Drug Research
Leiden, South Holland, Netherlands, 2333