Study to Evaluate DNL151 in Subjects With Parkinson's Disease

April 14, 2023 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was previously posted by Denali Therapeutics. In July, 2022, sponsorship of the trial was transferred to Biogen.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Netherlands
      • Leeuwarden, Netherlands, 8934AD
        • QPS
    • South Holland
      • Leiden, South Holland, Netherlands, 2333
        • Centre for Human Drug Research
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research
      • Merthyr Tydfil, United Kingdom, CF48 4DR
        • Simbec-Orion Clinical Pharmacology
  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • PPD Clinical Research Unit
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral repeating dose
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Randomization to Day 42
Randomization to Day 42
Number of Subjects with laboratory test abnormalities
Time Frame: Randomization to Day 42
Randomization to Day 42
Number of Subjects with vital sign abnormalities
Time Frame: Randomization to Day 42
Randomization to Day 42
Number of Subjects with electrocardiogram (ECG) abnormalities
Time Frame: Randomization to Day 42
Randomization to Day 42
Number of Subjects with clinically significant neurological examination abnormalities
Time Frame: Randomization to Day 42
Randomization to Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151
Time Frame: Randomization to Day 28
Randomization to Day 28
Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151
Time Frame: Randomization to Day 28
Randomization to Day 28
Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151
Time Frame: Randomization to Day 28
Randomization to Day 28
Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151
Time Frame: Randomization to Day 28
Randomization to Day 28
Pharmacokinetic measure of CSF concentrations of DNL151
Time Frame: Randomization to Day 28
Randomization to Day 28
Pharmacodynamic measure of pS935 in whole blood
Time Frame: Randomization to Day 28
Randomization to Day 28
Pharmacodynamic measure of pRab10 in PBMCs
Time Frame: Randomization to Day 28
Randomization to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2019

Primary Completion (Actual)

December 2, 2020

Study Completion (Actual)

December 2, 2020

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNLI-C-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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