The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Site JP00001
Tokyo, Tokyo, Japan
Pharmacokinetics (PK) parameter of ASP1517: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameter of ASP1517: Cmax
Cmax: Maximum concentration
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: AUClast
AUClast: Area under the concentration-time curve from the time of dosing extrapolated to the last measurable concentration
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: CL/F
CL/F: Apparent total systemic clearance
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: t1/2
t1/2: Terminal elimination half-life
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tmax
tmax: Time of Cmax
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
PK parameters of ASP1517: tlag
tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
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PK parameters of ASP1517: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase
Time frame: Pre-dose, 0.5, 1, 2, 3, 5, 6, 8, 12, 16, 24, 36, 48, 60 and 72 hr after dosing
Safety assessed by Adverse events
Time frame: Up to 72 hours after final study drug dosing
Safety assessed by Vital signs
Supine blood pressure, supine pulse rate and axillary body temperature
Time frame: Up to 72 hours after each study drug dosing
Safety assessed by Laboratory tests
Hematology, blood biochemistry and urinalysis
Time frame: Up to 72 hours after each study drug dosing
Safety assessed by Standard 12-lead ECG
ECG: Electrocardiogram
Time frame: Up to 72 hours after each study drug dosing