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Study to Evaluate DNL201 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: NCT03710707
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Denali Therapeutics Inc.

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 DNL201 in subjects with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: DNL201 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel 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 DNL201 in Subjects With Parkinson's Disease
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : December 6, 2019
Actual Study Completion Date : December 6, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DNL201 low dose Drug: DNL201
Oral repeating dose
Experimental: DNL201 high dose Drug: DNL201
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 DNL201 [ Time Frame: Randomization to Day 28 ]
  2. Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL201 [ Time Frame: Randomization to Day 28 ]
  3. Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL201 [ Time Frame: Randomization to Day 28 ]
  4. Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL201 [ Time Frame: Randomization to Day 28 ]
  5. Pharmacokinetic measure of CSF concentrations of DNL201 [ Time Frame: Randomization to Day 28 ]
  6. Pharmacodynamic measure of pS935 in whole blood and/or PBMCs [ 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 80 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.
  • 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
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): NCT03710707


Locations
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United States, California
Clinical Site(s)
Long Beach, California, United States, 90808
United States, Colorado
Clinical Site(s)
Aurora, Colorado, United States, 80045
United States, Florida
Clinical Site(s)
Miami, Florida, United States, 33143
Clinical Site(s)
Orlando, Florida, United States, 32806
United States, Michigan
Clinical Site(s)
Farmington Hills, Michigan, United States, 48334
United States, Pennsylvania
Clinical Site(s)
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Clinical Site(s)
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Denali Therapeutics Inc.
More Information
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Responsible Party: Denali Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03710707    
Other Study ID Numbers: DNLI-B-0002
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Denali Therapeutics Inc.:
LRRK2
Parkinson's Disease
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