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Study to Evaluate DNL151 in Subjects With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056689
Recruitment Status : Completed
First Posted : August 14, 2019
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: DNL151 Drug: Placebo Phase 1

Detailed Description:
This study was previously posted by Denali Therapeutics. In July, 2022, sponsorship of the trial was transferred to Biogen.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's Disease
Actual Study Start Date : July 23, 2019
Actual Primary Completion Date : December 2, 2020
Actual Study Completion Date : December 2, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DNL151 Low Dose Drug: DNL151
Oral repeating dose
Experimental: DNL151 Mid Dose Drug: DNL151
Oral repeating dose
Experimental: DNL151 High Dose Drug: DNL151
Oral repeating dose
Placebo Comparator: Placebo Drug: Placebo
Oral repeating dose


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Randomization to Day 42 ]
  2. Number of Subjects with laboratory test abnormalities [ Time Frame: Randomization to Day 42 ]
  3. Number of Subjects with vital sign abnormalities [ Time Frame: Randomization to Day 42 ]
  4. Number of Subjects with electrocardiogram (ECG) abnormalities [ Time Frame: Randomization to Day 42 ]
  5. Number of Subjects with clinically significant neurological examination abnormalities [ Time Frame: Randomization to Day 42 ]

Secondary Outcome Measures :
  1. Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151 [ Time Frame: Randomization to Day 28 ]
  2. Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151 [ Time Frame: Randomization to Day 28 ]
  3. Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151 [ Time Frame: Randomization to Day 28 ]
  4. Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151 [ Time Frame: Randomization to Day 28 ]
  5. Pharmacokinetic measure of CSF concentrations of DNL151 [ Time Frame: Randomization to Day 28 ]
  6. Pharmacodynamic measure of pS935 in whole blood [ Time Frame: Randomization to Day 28 ]
  7. Pharmacodynamic measure of pRab10 in PBMCs [ Time Frame: Randomization to Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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, 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056689


Locations
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United States, Florida
PPD Clinical Research Unit
Orlando, Florida, United States, 32806
United States, Michigan
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Belgium
UZ Leuven
Leuven, Belgium, 3000
Netherlands
Centre for Human Drug Research
Leiden, South Holland, Netherlands, 2333
QPS
Leeuwarden, Netherlands, 8934AD
United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
MAC Clinical Research
Manchester, United Kingdom, M13 9NQ
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT04056689    
Other Study ID Numbers: DNLI-C-0003
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
URL: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Biogen:
LRRK2
Movement Disorders
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases