Population Pharmacokinetic Analysis of Compound A and Its Metabolite in Healthy Subjects and Patients with Diabetic Nephropathy

Authors: Nakamura T, Kubota T, Jaworowicz DJ, Lin KJ, Kawaguchi A
Conference: PAGE
Keywords: mineralocorticoid receptor, NONMEM, pharmacokinetic, PK, PopPK
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

Compound A is a potent and highly selective non-steroidal mineralocorticoid receptor (MR) antagonist being developed for the treatment of diabetic nephropathy and other potential indications. Richly sampled PK data collected in phase 1 studies exhibited complex PK profiles for Compound A (secondary and tertiary peaks as well as prolonged absorption profiles following initial peak concentrations in conjunction with dose-dependent reductions in exposure with increasing doses) and its major metabolite (Metabolite B; slow formation and elimination).

Population Approach Group in Europe (PAGE), June 6-9 2017, Budapest, Hungary

By Tadakatsu Nakamura, Tomoko Kubota, David Jaworowicz, Kuan-Ju Lin, Atsuhiro Kawaguchi