Study to Evaluate DNL151 in Subjects With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04056689
• Other study ID #: DNLI-C-0003
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2019
• Est. completion date: December 2, 2020

Study information

• Verified date: April 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

• 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, 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• DNL151
Oral repeating dose
• Placebo
Oral repeating dose

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Netherlands	QPS	Leeuwarden
Netherlands	Centre for Human Drug Research	Leiden	South Holland
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	MAC Clinical Research	Manchester
United Kingdom	Simbec-Orion Clinical Pharmacology	Merthyr Tydfil
United States	Quest Research Institute	Farmington Hills	Michigan
United States	PPD Clinical Research Unit	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)		Randomization to Day 42
Primary	Number of Subjects with laboratory test abnormalities		Randomization to Day 42
Primary	Number of Subjects with vital sign abnormalities		Randomization to Day 42
Primary	Number of Subjects with electrocardiogram (ECG) abnormalities		Randomization to Day 42
Primary	Number of Subjects with clinically significant neurological examination abnormalities		Randomization to Day 42
Secondary	Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL151		Randomization to Day 28
Secondary	Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL151		Randomization to Day 28
Secondary	Pharmacokinetic measure of trough plasma observed concentration (Ctrough) of DNL151		Randomization to Day 28
Secondary	Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL151		Randomization to Day 28
Secondary	Pharmacokinetic measure of CSF concentrations of DNL151		Randomization to Day 28
Secondary	Pharmacodynamic measure of pS935 in whole blood		Randomization to Day 28
Secondary	Pharmacodynamic measure of pRab10 in PBMCs		Randomization to Day 28