The objective of this study is to compare and evaluate the pharmacokinetics of ASP015K in patients with impaired hepatic function and subjects with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Oral
Site JP00001
Fukuoka, Japan
Site JP00003
Kanagawa, Japan
Site JP00002
Tokyo, Japan
Site JP00004
Tokyo, Japan
Site JP00005
Tokyo, Japan
Pharmacokinetics (PK) parameter of ASP015K: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72 hr after dosing
PK parameter of ASP015K: Cmax
Cmax: Maximum concentration
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameter of metabolites: AUCinf
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameter of metabolites: Cmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
Safety assessed by AEs
Time frame: Up to 7 days after the study drug dosing
Safety assessed by Vital signs
Supine blood pressure, supine pulse rate and axillary body temperature
Time frame: Up to 7 days after the study drug dosing
Safety assessed by Laboratory tests
Hematology, blood biochemistry, and urinalysis
Time frame: Up to 7 days after the study drug dosing
Safety assessed by 12-lead ECGs
Time frame: Up to 7 days after the study drug dosing
PK parameters of ASP015K: AUClast
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Site JP00006
Tokyo, Japan
AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: t1/2
t1/2: Terminal elimination half-life
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: tmax
tmax: Time of Cmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: CL/F
CL/F: Apparent total systemic clearance
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of ASP015K: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: AUClast
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: t1/2
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing
PK parameters of metabolites: tmax
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 60 and 72hr after dosing