Overview

Study to Evaluate DNL151 in Subjects With Parkinson's Disease

Status:
Completed
Trial end date:
2020-12-02
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Denali Therapeutics Inc.
Criteria
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