A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease
- Registration Number
- NCT05924243
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H\&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RO7486967 Arm RO7486967 Participants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose. Placebo Placebo Matching placebo
- Primary Outcome Measures
Name Time Method Percentage of Participants with adverse events (AEs) Up to 45 Days The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline From Baseline to Up to 45 Days
- Secondary Outcome Measures
Name Time Method Time to maximum concentration of RO7486967 in Plasma Day 1, Day 15, and Day 28 Maximum concentration (Cmax) of RO7486967 in Plasma Day 1, Day 15, and Day 28 Area under the curve (AUC) RO7486967 in Plasma Day 1, Day 15, and Day 28 Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET From Baseline to Approximately Day 25
Trial Locations
- Locations (17)
Brain Research Center B.V
🇳🇱Amsterdam, Netherlands
UMC St Radboud
🇳🇱Nijmegen, Netherlands
Brain Research Center Zwolle
🇳🇱Zwolle, Netherlands
University of Exeter
🇬🇧Exeter, United Kingdom
Barts Health NHS Trust
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust; Charing Cross Hospital
🇬🇧London, United Kingdom
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
CenExel Rocky Mountain Clinical Research, LLC
🇺🇸Englewood, Colorado, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Advent Health Orlando
🇺🇸Orlando, Florida, United States
Quest Research Institute
🇺🇸Farmington Hills, Michigan, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
The Movement Disorder Clinic of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
University Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF
🇬🇧London, United Kingdom
Campus for Ageing & Vitality; Clincal Ageing Research Unit
🇬🇧Newcastle, United Kingdom