Site JP00001
Tokyo, Japan
NCT Number: NCT02805374
The objective of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of ASP1517 in non-elderly healthy adult male subjects.
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Notify Me20 year–44 year
Male
Interventional
Phase 1
Tokyo, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral
Time frame: Up to Day 4 of each treatment period
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Time frame: Up to Day 4 of each treatment period
Cmax: Maximum concentration
Time frame: Up to Day 4 of each treatment period
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
Time frame: Up to Day 4 of each treatment period
CL/F: Apparent total systemic clearance
Time frame: Up to Day 4 of each treatment period
λz: Terminal rate constant
Time frame: Up to Day 4 of each treatment period
MRTinf: Mean residence time extrapolated to infinity
Time frame: Up to Day 4 of each treatment period
t1/2: Terminal elimination half-life
Time frame: Up to Day 4 of each treatment period
tmax: Time of Cmax
Time frame: Up to Day 4 of each treatment period
tlag: Lag time
Time frame: Up to Day 4 of each treatment period
Vz/F: Apparent volume of distribution during the terminal elimination phase
Time frame: Up to Day 4 of each treatment period
Ae: Cumulative amount of ASP1517 excreted into urine
Time frame: Up to Day 4 of each treatment period
CLR: Renal clearance
Time frame: Up to Day 9 of Period 2
Time frame: Up to Day 9 of Period 2
Time frame: Up to Day 9 of Period 2
Time frame: Up to Day 9 of Period 2
ECG: Electrocardiogram
Astellas Pharma Inc
Industry
ASP1517 Pharmacokinetic Study - Evaluation of Food Effect on the Pharmacokinetics of ASP1517
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