Chronic Kidney Disease Clinical Trial
Official title:
A Phase 1, Single and Multiple Dosing Study to Evaluate Pharmacokinetics and Pharmacodynamics of ASP3325 in Patients With Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis
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.
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