The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
50 mg safinamide on Day 1
CRS Clinical Research Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Cmax of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide
Time frame: 12 to 14 days
AUC0-∞ of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide
Time frame: 12 to 14 days
Cmax of safinamide metabolite NW-1689 in plasma
Time frame: 12 to 14 days
Cmax of safinamide metabolite NW-1153 in plasma
Time frame: 12 to 14 days
Cmax of safinamide metabolite NW-1689 acylglucuronide in plasma
Time frame: 12 to 14 days
AUC0-∞ of safinamide metabolite NW-1689 in plasma
Time frame: 12 to 14 days
AUC0-∞ of safinamide metabolite NW-1153 in plasma
Time frame: 12 to 14 days
AUC0-∞ of safinamide metabolite NW-1689 acylglucuronide in plasma
Time frame: 12 to 14 days
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