drugset / Trial / NCT02218099

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease

NCT02218099

Phase 1/2 Completed 55 enrolled Astellas Pharma Europe B.V.
RandomizedParallel-groupTriple-blindBasic science

Summary

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).

Timeline

Start
2013-09-16
Primary completion
2014-09-09
Completion
2014-09-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP8232 Small molecule Oral