Study to Evaluate DNL151 in Subjects With Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-23

Study Completion Date

2020-12-02

Brief Summary

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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.

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Detailed Description

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

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DNL151 Low Dose

Group Type EXPERIMENTAL

DNL151

Intervention Type DRUG

Oral repeating dose

DNL151 Mid Dose

Group Type EXPERIMENTAL

DNL151

Intervention Type DRUG

Oral repeating dose

DNL151 High Dose

Group Type EXPERIMENTAL

DNL151

Intervention Type DRUG

Oral repeating dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral repeating dose

Interventions

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DNL151

Oral repeating dose

Intervention Type DRUG

Placebo

Oral repeating dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No