The objective of this study is to evaluate the effect of lanthanum carbonate hydrate on the pharmacokinetics (PK) of ASP1517 in non-elderly healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Oral dose
Oral dose
Site JP00001
Tokyo, Tokyo, Japan
Pharmacokinetics (PK) parameter of ASP1517 in plasma: AUCINF
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: AUC24h
AUC24h: Area under the concentration-time curve from the time of dosing to 24h
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Cmax
Cmax: Maximum concentration
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: AUClast
AUC last: Area under the concentration-time curve from the time of dosing to the last measurable concentration
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: CL/F
CL/F: Apparent total systemic clearance
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: t1/2
t1/2: Terminal elimination half-life
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Lambda z
Lambda z: Terminal elimination rate constant
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: MRTinf
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
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Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tmax
tmax : Time of Cmax
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: tlag
tlag: Time point prior to the time point corresponding to the first measurable (non-zero) concentration
Time frame: Up to 72hr after each dosing
PK parameter of ASP1517 in plasma: Vz/F
Vz/F: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing
Time frame: Up to 72hr after each dosing
Safety assessed by incidence of adverse events
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by supine blood pressure
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by supine pulse rate
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by axillary body temperature
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Hematology
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Blood biochemistry
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by Laboratory tests: Urinalysis
Time frame: Up to 7 days after drug dosing of period 2
Safety assessed by 12-lead electrocardiogram
Time frame: Up to 7 days after drug dosing of period 2