The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
74
Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
placebo - concentrate for solution for infusion, single dose
California Clinical Trials Medical Group (CCTMG)
Glendale, California, United States
Reserach Center of America
Hollywood, Florida, United States
PPD
Orlando, Florida, United States
Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital
Baltimore, Maryland, United States
Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
Time frame: From dosing to Day 84
AUC 0-t
Area under the Lu AF82422 plasma concentration curve from zero to time t
Time frame: From dosing to Day 84
Cmax
Maximum observed plasma concentration of Lu AF82422
Time frame: From dosing to Day 84
CL
Clearance of Lu AF82422
Time frame: From dosing to Day 84
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