The objectives of this study are to evaluate the safety and tolerability of a single and multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered three times a day.
\<Part 1: Single ascending dose\> Primary objective * To evaluate the safety and tolerability of a single oral dose of ASP3325 in non-elderly, healthy adult Japanese male and female, and Caucasian male subjects Secondary objectives * To evaluate the pharmacokinetics and pharmacodynamics * To evaluate gender differences in the pharmacokinetics and pharmacodynamics * To evaluate ethnic differences in the pharmacokinetics and pharmacodynamics between Japanese and Caucasians \<Part 2: Multiple ascending dose\> Primary objective * To evaluate the safety and tolerability of multiple oral doses of ASP3325 in non-elderly, healthy adult Japanese male and female subjects Secondary objectives * To evaluate the pharmacokinetics and pharmacodynamics * To evaluate gender differences in the pharmacokinetics and pharmacodynamics \<Part 3: Evaluation of the effect of administration timing\> Primary objective * To evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered three times a day at different administration timings of 30 minutes before a meal, during a meal, 30 minutes after a meal, and 2 hours after a meal in non-elderly, healthy adult Japanese male subjects in a crossover design Secondary objective * To evaluate the safety and pharmacokinetics
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
124
Unnamed facility
Tokyo, Japan
Safety developed by adverse events, Part 1
Time frame: Up to Day 7 under Fasted and Fed Conditions
Safety developed by adverse events, Part 2
Time frame: Up to Day 13
Safety developed by adverse events, Part 3
Time frame: Up to Day 8 in Period 4
Safety developed by Vital signs, Part 1
Time frame: Up to Day 7
Safety developed by Vital signs, Part 2
Time frame: Up to Day 13
Safety developed by Vital signs, Part 3
Time frame: Up to Day 8 in Period 4
Safety developed by Laboratory Tests, Part 1
Time frame: Up to Day 7 under Fasted and Fed Conditions
Safety developed by Laboratory Tests, Part 2
Time frame: Up to Day 13
Safety developed by Laboratory Tests, Part 3
Time frame: Up to Day 8 in Period 4
Safety developed by 12-Lead ECG, Part 1
ECG = electrocardiogram
Time frame: Up to Day 7 under Fasted and Fed Conditions
Safety developed by 12-Lead ECG, Part 2
ECG = electrocardiogram
Time frame: Up to Day 13
Safety developed by 12-Lead ECG, Part 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ECG = electrocardiogram
Time frame: Up to Day 8 in Period 4
12-lead continuous ECG for QT assessment
ECG: Electrocardiogram
Time frame: Up to Day 2 in examination only for administration under fasted condition in Part 1 and Part 2
Standard 12-lead ECG for QT assessment
ECG: Electrocardiogram
Time frame: Day -1 ~ 2 in Part 1 and from Day -1 ~1 and Day7~8 in Part 2
Plasma concentration of ASP3325
Time frame: Day 1, 2, 3 and 4 in Part 1 under Fasted and Fed Conditions, Day 1, 2, 4, 6, 7, 8, 9 and 10 in Part 2, Day 1, 2, 3, 4, 5 in Part 3
Urinary concentration of ASP3325
Time frame: Day 1, 2, 3 and 4 in Part 1 under Fasted and Fed Conditions, Day -1, 1, 2, 7, and 8 in Part 2, Day -1, 1, 2, 3, 4, 5 in Part 3
Amount of phosphorus excreted in urine and FEP%
FEP% = Fractional Phosphate Excretion
Time frame: Day 1, 2, 3 and 4 in Part 1 under Fasted Conditions
Amount of phosphorus excreted in urine
Time frame: Day -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 in Part 2
Amount of calcium excreted in urine
Time frame: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2
Amount of phosphorus excreted in feces
Time frame: Day -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 in Part 2
Amount of calcium excreted in feces
Time frame: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2
Amount of FEP%
FEP%:Fractional phosphate excretion
Time frame: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2
Amount of phosphorus excreted in urine
Time frame: Day -1, 1, 2, 3, and 4 in Part 3
Amount of calcium excreted in urine
Time frame: Day -1, 1, 2, 3, and 4 in Part 3
Amount of phosphorus excreted in feces
Time frame: Day -1, 1, 2, 3, and 4 in Part 3
Amount of calcium excreted in feces
Time frame: Day -1, 1, 2, 3, and 4 in Part 3
Amount of FEP%
FEP%: Fractional phosphate excretion
Time frame: Day -1, 1, 2, 3, and 4 in Part 3