The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.
The study consists of different parts. Part A of the study will consist of once daily (OD) cohorts (OD Cohort 1 to 3), as well as twice daily (BID) cohorts (BID Cohorts A1 and A2). Part B will consist of 3 cohorts (Cohorts B1, B2, and B3) whereby participants will be administered Lu AF28996 BID.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
capsule, orally, doses and dose escalation scheme will be decided upon at dosing conferences
CenExel Los Alamitos
Los Alamitos, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Velocity
Hallandale, Florida, United States
Number of Participants with Treatment-emergent Adverse Events
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
Time frame: From Baseline to 5.5 Months
Cmax of Lu AF28996
Maximum observed plasma concentration of Lu AF28996
Time frame: 0 (predose) to 24 hours postdose on Day 1 to Day 47
Tmax of Lu AF28996
Nominal Time Corresponding to the Occurrence of Cmax
Time frame: 0 (predose) to 24 hours postdose on Day 1 to Day 47
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Parkinson's Disease Treatment Center of SW FL
Port Charlotte, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Neurology Consultants of Nebraska
Omaha, Nebraska, United States
Inland Nortwest Research
Spokane, Washington, United States
Caen Normandy University
Caen, Basse-Normandie, France
...and 5 more locations