Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056689
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Denali Therapeutics Inc.

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 Disease Drug: DNL151 low dose Drug: DNL151 high dose Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 DNL151 in Subjects With Parkinson's Disease
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DNL151 low dose
DNL151 low dose will be orally administered.
Drug: DNL151 low dose
DNL151 low dose

Experimental: DNL151 high dose
DNL151 high dose will be orally administered.
Drug: DNL151 high dose
DNL151 high dose

Placebo Comparator: Placebo
Placebo will be orally administered.
Drug: Placebo
Placebo




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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

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


Contacts
Layout table for location contacts
Contact: Project Assistant +32 2 723 26 68 Mukunde.Sano@ppdi.com

Locations
Layout table for location information
Netherlands
Centre for Human Drug Research Recruiting
Leiden, South Holland, Netherlands, 2333
Contact: Maurits Vissers, PharmD    +31 715246478    MVissers@chdr.nl   
Sponsors and Collaborators
Denali Therapeutics Inc.

Layout table for additonal information
Responsible Party: Denali Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04056689     History of Changes
Other Study ID Numbers: DNLI-C-0003
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

Layout table for additional information
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 Denali Therapeutics Inc.:
LRRK2
Parkinson's Disease
Movement Disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases