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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.

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE December 4, 2018
Actual Primary Completion Date December 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL201 [ Time Frame: Randomization to Day 28 ]
  • Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL201 [ Time Frame: Randomization to Day 28 ]
  • Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL201 [ Time Frame: Randomization to Day 28 ]
  • Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL201 [ Time Frame: Randomization to Day 28 ]
  • Pharmacokinetic measure of CSF concentrations of DNL201 [ Time Frame: Randomization to Day 28 ]
  • Pharmacodynamic measure of pS935 in whole blood and/or PBMCs [ Time Frame: Randomization to Day 28 ]
  • Pharmacodynamic measure of pRab10 in PBMCs [ Time Frame: Randomization to Day 28 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate DNL201 in Subjects With Parkinson's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: DNL201
    Oral repeating dose
  • Drug: Placebo
    Oral repeating dose
Study Arms  ICMJE
  • Experimental: DNL201 low dose
    Intervention: Drug: DNL201
  • Experimental: DNL201 high dose
    Intervention: Drug: DNL201
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2020)
29
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2018)
30
Actual Study Completion Date  ICMJE December 6, 2019
Actual Primary Completion Date December 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03710707
Other Study ID Numbers  ICMJE DNLI-B-0002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Denali Therapeutics Inc.
Study Sponsor  ICMJE Denali Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Denali Therapeutics Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP