The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal
\[Part 1\] This part is an open-label, uncontrolled study to evaluate PK and safety with single dosing of ASP3325 in hemodialysis patients. After washout period of therapeutic medication for hyperphosphatemia, six subjects will receive single oral administration of ASP3325 (Tablet A) on a non-dialysis day (Day 1). \[Part 2\] This part is a 2-arm, open-label, uncontrolled study to evaluate PD, PK and safety with dosing ASP3325 Tablet B t.i.d. before or just after each meal. Eligible subjects at screening will be entered into the washout period for stopping their phosphate-binding treatment. 20 subjects with serum inorganic phosphorus (Pi) level between ≥6.0 and \<10.0 mg/dL during the washout period (washout period week 1 or washout period week 2) will be randomized to each treatment group and ASP3325 will be administered for 2 weeks until Day 14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
oral
Site: 4
Aichi, Japan
Site: 5
Aichi, Japan
Site: 1
Ibaraki, Japan
Site: 2
Ibaraki, Japan
Site: 3
Shizuoka, Japan
Safety assessed by adverse events: Part 1
Time frame: Up to Day 7
Safety assessed by adverse events: Part 2
Time frame: Up to Day 22
Safety assessed by vital signs: Part 1
Vital signs include body temperature, blood pressure and pulse rate)
Time frame: Up to Day 7
Safety assessed by vital signs: Part 2
Vital signs include body temperature, blood pressure and pulse rate)
Time frame: Up to Day 22
Safety assessed by clinical laboratory test: Part 1
Clinical laboratory tests include hematology and biochemistry
Time frame: Up to Day 7
Safety assessed by clinical laboratory test: Part 2
Clinical laboratory tests include hematology and biochemistry
Time frame: Up to Day 22
Safety assessed by 12-Lead ECG: Part 1
ECG: electrocardiogram
Time frame: Up to Day 7
Safety assessed by 12-Lead ECG: Part 2
ECG: electrocardiogram
Time frame: Up to Day 22
Cmax of unchanged ASP3325
Cmax:maximum plasma concentration
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
tmax of unchanged ASP3325
tmax = time to reach maximum plasma concentration
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUClast of ASP3325
AUClast: Area under the Curve of plasma concentration during observation period in each observational day
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
AUCinf of ASP3325
AUCinf: Area under the Curve of plasma concentration
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
t1/2 of ASP3325
t1/2 = apparent terminal elimination half-life
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Vz/F of ASP3325
Vz/F = apparent volume of distribution
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
CL/F of ASP3325
CL/F = oral clearance
Time frame: Part 1 Before administration, Day 1, 2, 4, 5 and 7
Ctrough of ASP3325
Ctrough = observed trough concentration
Time frame: Part 2 Before administration, Day 3, 5, 8, 10, 12, 15 and 22
Serum Pi of ASP3325
Serum Pi: serum phosphate concentration before dialysis
Time frame: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum Calcium (adjusted for albumin)
Corrected value of Calcium (Ca) (mg/dL) = Observed value of Ca (mg/dL) + \[4-albumin (g/dL)
Time frame: Part 2 Day -21, -14, and -7 in washout period, Day 1, 8, 15 and 22
Serum concentration of intact PTH before dialysis
PTH = parathyroid hormone
Time frame: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22
Serum concentration of FGF23
FGF23 = fibroblast growth factor 23
Time frame: Part 2 Day -21 in washout period, Day 1, 8, 15 and 22