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Study to Evaluate DNL151 in Subjects With Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DNL151
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring LRRK2, Movement Disorders

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PPD Clinical Research Unit
  • Quest Research Institute
  • UZ Leuven
  • Centre for Human Drug Research
  • QPS
  • Royal Liverpool University Hospital
  • MAC Clinical Research
  • Simbec-Orion Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

DNL151 Low Dose

DNL151 Mid Dose

DNL151 High Dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Subjects with laboratory test abnormalities
Number of Subjects with vital sign abnormalities
Number of Subjects with electrocardiogram (ECG) abnormalities
Number of Subjects with clinically significant neurological examination abnormalities

Secondary Outcome Measures

Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151
Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151
Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151
Pharmacokinetic measure of CSF concentrations of DNL151
Pharmacodynamic measure of pS935 in whole blood
Pharmacodynamic measure of pRab10 in PBMCs

Full Information

First Posted
August 12, 2019
Last Updated
April 14, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT04056689
Brief Title
Study to Evaluate DNL151 in Subjects With Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
LRRK2, Movement Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DNL151 Low Dose
Arm Type
Experimental
Arm Title
DNL151 Mid Dose
Arm Type
Experimental
Arm Title
DNL151 High Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DNL151
Intervention Description
Oral repeating dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral repeating dose
Primary Outcome Measure Information:
Title
Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Randomization to Day 42
Title
Number of Subjects with laboratory test abnormalities
Time Frame
Randomization to Day 42
Title
Number of Subjects with vital sign abnormalities
Time Frame
Randomization to Day 42
Title
Number of Subjects with electrocardiogram (ECG) abnormalities
Time Frame
Randomization to Day 42
Title
Number of Subjects with clinically significant neurological examination abnormalities
Time Frame
Randomization to Day 42
Secondary Outcome Measure Information:
Title
Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151
Time Frame
Randomization to Day 28
Title
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151
Time Frame
Randomization to Day 28
Title
Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151
Time Frame
Randomization to Day 28
Title
Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151
Time Frame
Randomization to Day 28
Title
Pharmacokinetic measure of CSF concentrations of DNL151
Time Frame
Randomization to Day 28
Title
Pharmacodynamic measure of pS935 in whole blood
Time Frame
Randomization to Day 28
Title
Pharmacodynamic measure of pRab10 in PBMCs
Time Frame
Randomization to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
PPD Clinical Research Unit
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Quest Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre for Human Drug Research
City
Leiden
State/Province
South Holland
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
QPS
City
Leeuwarden
ZIP/Postal Code
8934AD
Country
Netherlands
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
MAC Clinical Research
City
Manchester
ZIP/Postal Code
M13 9NQ
Country
United Kingdom
Facility Name
Simbec-Orion Clinical Pharmacology
City
Merthyr Tydfil
ZIP/Postal Code
CF48 4DR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org

Learn more about this trial

Study to Evaluate DNL151 in Subjects With Parkinson's Disease

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