Healthy Subjects Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 (Part 1) and a Multiple Dose, Placebo-controlled Exploratory Safety, Pharmacokinetic and Pharmacodynamic Study in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease (Part 2)
This study consists of two parts.
Part 1 evaluates the effect of renal impairment on the PK and PD of a single dose of ASP8232.
In addition, the safety and tolerability will be assessed.
Part 2 evaluates the PK, PD, and safety and tolerability of multiple doses of ASP8232
compared with placebo in Type 2 Diabetes Mellitus (T2DM) subjects with Chronic Kidney Disease
(CKD).
This is a two-part study. Part 1 compares the pharmacokinetics (PK), pharmacodynamics (PD)
and safety and tolerability of ASP8232 in healthy subjects with subjects with different
degrees of renal impairment; Part 2 is a multiple-dose, placebo-controlled study to evaluate
the PK, PD and safety and tolerability of multiple doses of ASP8232 in T2DM subjects with
CKD.
Part 1:
Subjects reside in the clinic for 9 days, receiving a single oral dose of ASP8232 on Day 1
under fasted conditions followed by a 168-hours blood and urine PK/PD sampling period.
Subjects are discharged on Day 8 and return to the clinic on Days 10, 12, 14, 21, 28, and 42
for the collection of blood PK/PD samples. An End of Study Visit (ESV) takes place after the
last PK sample is collected on Day 56.
Part 2:
Subjects are admitted to the clinic on Day -2 in order to collect PD urine samples before
dosing begins on Day 1. Subjects receive multiple oral doses of ASP8232 or placebo for 28
days. They are discharged on Day 8 and return to the clinic on Days 14 and 21, and Days 27 to
29 for blood PK/PD and urine PD samples. An ESV takes place 14 to 28 days after the last
PK/PD sample is collected.
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