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Luseogliflozin, an SGLT2 Inhibitor, in Japanese Patients With Mild/Moderate Hepatic Impairment: A Pharmacokinetic Study.

Authors
  • Samukawa, Yoshishige1
  • Sata, Michio2
  • Furihata, Kenichi3
  • Ito, Toshifumi4
  • Ueda, Naohiko5
  • Ochiai, Hidekazu1
  • Sakai, Soichi1
  • Kumagai, Yuji6
  • 1 Taisho Pharmaceutical Co., Ltd., Tokyo, Japan. , (Japan)
  • 2 Kurume University School of Medicine, Fukuoka, Japan. , (Japan)
  • 3 Keikokai Medical Corp. P-One Clinic, Tokyo, Japan. , (Japan)
  • 4 Japan Community Healthcare Organization Osaka Hospital, Osaka, Japan. , (Japan)
  • 5 Medical Corporation Kyosoukai AMC Nishi Umeda Clinic, Osaka, Japan. , (Japan)
  • 6 Kitasato University School of Medicine, Kanagawa, Japan. , (Japan)
Type
Published Article
Journal
Clinical pharmacology in drug development
Publication Date
Sep 01, 2017
Volume
6
Issue
5
Pages
439–447
Identifiers
DOI: 10.1002/cpdd.364
PMID: 28783873
Source
Medline
Keywords
License
Unknown

Abstract

This open-label, parallel-group study evaluated the effect of mild and moderate hepatic impairment on the pharmacokinetics of a single dose of luseogliflozin in Japanese subjects. Thirteen subjects with hepatic impairment (mild, n = 8; moderate, n = 5) and 6 healthy subjects received a single 5-mg dose of luseogliflozin. Serial blood sampling over 72 hours and 24-hour urine collection were done for pharmacokinetic analysis of luseogliflozin and its metabolites and to measure pharmacokinetic and pharmacodynamic parameters, respectively. Demographic characteristics were similar at baseline for both groups. Geometric mean ratios of maximum plasma concentration (Cmax ) and area under the plasma concentration-time curve from time zero to infinity (AUCinf [90%CI]) of unchanged luseogliflozin were 1.02 (0.790-1.32) and 0.774 (0.580-1.03), respectively, on comparing patients with hepatic impairment with healthy subjects, and 0.939 (0.752-1.17) and 1.00 (0.780-1.28), respectively, in subjects with mild and moderate hepatic impairment. Although mean plasma concentrations of metabolites were slightly higher in patients with hepatic impairment versus healthy subjects, their time-course plasma concentrations were very low compared with those of unchanged luseogliflozin. Single-dose luseogliflozin 5 mg was well tolerated by study participants, indicating luseogliflozin dose adjustment is not necessary in patients with mild and moderate hepatic impairment.

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