The objective of this study is to compare the pharmacokinetics of ASP015K in patients with impaired renal function and subjects with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
oral
Site JP00001
Tokyo, Japan
Site JP00002
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 72hr 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 Adverse Events (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
ECG: Electrocardiogram
Time frame: Up to 7 days after the study drug dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK parameters of ASP015K: AUClast
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