The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Oral single dosing
Mochida Investigational sites
Tokyo, Japan
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 48 hours
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
Time frame: 48 hours
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 48 hours
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 48 hours
Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (kel: Elimination rate constant)
Time frame: 48 hours
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time frame: 48 hours
Pharmacokinetics (MRT: Mean residence time)
Time frame: 48 hours
Pharmacodynamics (Serum concentration of uric acid)
Time frame: 48 hours
Pharmacodynamics (Amount of uric acid excreted in urine)
Time frame: 48 hours
Safety (Incidence of treatment-emergent adverse events)
Time frame: 192 hours
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