The objective of this study is to evaluate the bioequivalence of a new tablet versus a current tablet of ASP015K under fasting conditions after single oral administration in healthy male subjects.
This is an open-label, randomized, single dose, 2-way crossover designed study. Forty non-elderly healthy male subjects will receive an ASP015K small tablet or an ASP015K current tablet in each period under fasted conditions. If the bioequivalence between two tablets cannot be demonstrated because of an insufficient number, an add-on subject study will be conducted as needed. The design of the add-on subject study will be the same with that of the initial study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
oral
Unnamed facility
Tokyo, Japan
Pharmacokinetics (PK) parameter of ASP015K: Area under the concentration-time curve (AUC) from the time of dosing to the time of the last sampling (AUCt)
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) parameter of ASP015K: Maximum concentration (Cmax)
Time frame: Up to 72 hours after each study drug dosing
Safety assessed by Adverse Events (AEs)
Time frame: Up to 6 days after the study drug dosing of Period 2
Safety assessed by Vital signs
Vital signs include systolic and diastolic blood pressures, pulse rate and temperature.
Time frame: Up to 6 days after the study drug dosing of Period 2
Safety assessed by Laboratory tests
Laboratory tests include hematology, biochemistry, urinalysis.
Time frame: Up to 6 days after the study drug dosing of Period 2
Safety assessed by 12-lead ECGs
12-lead ECG: 12-lead electrocardiogram
Time frame: Up to 6 days after the study drug dosing of Period 2
Pharmacokinetics (PK) profile of ASP015K: AUCinf
AUCinf: AUC from the time of dosing extrapolated to time infinity
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: AUClast
AUClast: AUC from the time of dosing to the last measurable concentration
Time frame: Up to 72 hours after each study drug dosing
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Pharmacokinetics (PK) profile of ASP015K: CL/F
CL/F: Apparent total systemic clearance
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: kel
kel: Terminal elimination rate constant
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: MRTinf
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: t1/2
t1/2: Terminal elimination half-life
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: tmax
tmax: Time of Cmax (Maximum concentration)
Time frame: Up to 72 hours after each study drug dosing
Pharmacokinetics (PK) profile of ASP015K: Vz/F
Apparent volume of distribution during the terminal elimination phase
Time frame: Up to 72 hours after each study drug dosing