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Completed

NCT Number: NCT03710707

Study to Evaluate DNL201 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 DNL201 in subjects with Parkinson's disease.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site(s), Long Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • sPD subgroup without a LRRK2 mutation; PD LRRK2 subgroup with LRRK2 mutation
  • Screening dopamine transporter (DAT) SPECT scan with a DAT deficit consistent with Parkinson's disease
  • 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, and Blood Pressure
  • 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, 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

Treatment and study plan

DNL201

Drug

Oral repeating dose

Placebo

Drug

Oral repeating dose

Primary outcomes

  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 outcomes

  1. Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL201

    Time frame: Randomization to Day 28

  2. Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL201

    Time frame: Randomization to Day 28

  3. Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL201

    Time frame: Randomization to Day 28

  4. Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL201

    Time frame: Randomization to Day 28

  5. Pharmacokinetic measure of CSF concentrations of DNL201

    Time frame: Randomization to Day 28

  6. Pharmacodynamic measure of pS935 in whole blood and/or PBMCs

    Time frame: Randomization to Day 28

  7. Pharmacodynamic measure of pRab10 in PBMCs

    Time frame: Randomization to Day 28

Sponsors and collaborators

Lead sponsor

Denali Therapeutics Inc.

Industry

Registry information

Official study title

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's Disease

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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