The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
36
Site JP00001
Osaka, Osaka, Japan
Pharmacokinetics of ASP2151 in plasma: Cmax
Cmax: Maximum concentration
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: tmax
tmax: The time after dosing when Cmax occurs
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: t1/2
t1/2: Apparent terminal elimination half-life
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: C24
C24: Concentration at 24hours after dosing
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: AUC24
AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: AUCinf
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in plasma: CL/F
CL/F: Apparent total systemic clearance
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Ae
Ae: Amount excreted in urine
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Cumulative Ae
Time frame: Up to Day 9
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Pharmacokinetics of ASP2151 in urine: Ae%
Ae%: Percent of ASP2151 amount excreted in urine
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in urine: Cumulative Ae%
Time frame: Up to Day 9
Pharmacokinetics of ASP2151 in urine: CLR
CLR: Renal clearance
Time frame: Up to Day 9
Safety assessed by laboratory test: Hematology
Time frame: Up to Day 14
Safety assessed by laboratory test: blood biochemistry
Time frame: Up to Day 14
Safety assessed by laboratory test: urinalysis
Time frame: Up to Day 14
Safety assessed by Vital sign measurement: axillary body temperature
Time frame: Up to Day 14
Safety assessed by vital sign measurement: supine blood pressure
Time frame: Up to Day 14
Safety assessed by vital sign measurement: supine pulse rate
Time frame: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram
Time frame: Up to Day 14
Safety assessed by Standard 12-lead electrocardiogram for QT assessment
Time frame: Up to Day 14
Safety assessed by ophthalmological examination
Time frame: Up to Day 14
Safety assessed by incidence of adverse events
Time frame: Up to Day 14