Study to Evaluate DNL201 in Subjects With Parkinson's Disease

• Status: Completed
• Trial end date: 2019-12-06
• 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 DNL201 in subjects with Parkinson's disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denali Therapeutics Inc.

Criteria

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