Study to Evaluate DNL151 in Subjects With Parkinson's Disease

NCT04056689 | Completed Phase 1 FDA Drug

• 1 other identifier: DNLI-C-0003
• Study Type: interventional
• Target: 36
• Locations: 4 countries
• Sites: 8

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.

Conditions

Parkinson's Disease

Keywords

LRRK2; Movement Disorders

Outcome Measures

Primary Outcomes (5)

• Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Randomization to Day 42

• Number of Subjects with laboratory test abnormalities

  Randomization to Day 42

• Number of Subjects with vital sign abnormalities

  Randomization to Day 42

• Number of Subjects with electrocardiogram (ECG) abnormalities

  Randomization to Day 42

• Number of Subjects with clinically significant neurological examination abnormalities

  Randomization to Day 42

Secondary Outcomes (7)

• Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151

  Randomization to Day 28

• Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151

  Randomization to Day 28

• Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151

  Randomization to Day 28

• Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151

  Randomization to Day 28

• Pharmacokinetic measure of CSF concentrations of DNL151

  Randomization to Day 28

Study Arms (4)

DNL151 Low Dose

EXPERIMENTAL

Drug: DNL151

DNL151 Mid Dose

EXPERIMENTAL

Drug: DNL151

DNL151 High Dose

EXPERIMENTAL

Drug: DNL151

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DNL151 DRUG

Oral repeating dose

DNL151 High Dose; DNL151 Low Dose; DNL151 Mid Dose

Placebo DRUG

Oral repeating dose

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (8)

PPD Clinical Research Unit

Orlando, Florida, 32806, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre for Human Drug Research

Leiden, South Holland, 2333, Netherlands

Location

QPS

Leeuwarden, 8934AD, Netherlands

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

MAC Clinical Research

Manchester, M13 9NQ, United Kingdom

Location

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

Related Publications (1)

• Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.

  PMID: 40680102 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Interventions

DNL151

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: July 23, 2019
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (2); BE (1); GB (3); US (2)