The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
single dose of 50mg safinamide on Day 1
single dose of 50mg safinamide on Day 1
single dose of 50mg safinamide on Day 1
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
Pharmacokinetics of safinamide after single dose administration (Cmax)
Time frame: 10 days
Pharmacokinetics of safinamide after single dose administration (AUC)
Time frame: 10 days
Safety and tolerability after single dose administration of safinamide (Adverse Events)
Time frame: 12 days
Pharmacokinetics of safinamide metabolite NW1153 (Cmax)
Time frame: 10 days
Pharmacokinetics of safinamide metabolite NW1153 (AUC)
Time frame: 10 days
Pharmacokinetics of safinamide metabolite NW1689 (Cmax)
Time frame: 10 days
Pharmacokinetics of safinamide metabolite NW1689 (AUC)
Time frame: 10 days
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