Pharmacokinetics of Teneligliptin in Subjects With Renal Impairment.
The pharmacokinetics of teneligliptin was compared in renally impaired and healthy subjects. Subjects were assigned to one of four groups of eight subjects, according to the stage of disease [mild, moderate, severe or end stage renal disease (ESRD)], while matched healthy subjects were allocated to one of two reference groups. Mild, moderate and severe renal impairment had no effect on maximum plasma concentration (Cmax ) following a single oral dose of 20 mg teneligliptin, as defined in the FDA guideline. AUC0-∞ was increased in all groups relative to the reference group but this was unrelated to the degree of renal impairment. Mean plasma protein binding was <80% in all groups. Overall, teneligliptin was well tolerated by subjects with renal impairment or ESRD. Dialysis is not expected to affect the efficacy or safety of teneligliptin. These results indicate that dose adjustment may not be needed when teneligliptin is administered to subjects with mild, moderate or severe renal impairment or ESRD.
CRS Clinical Research Services Kiel GmbH, Kiel, Germany.
Atef
A
Halabi
CRS Clinical Research Services Kiel GmbH, Kiel, Germany.
Haidar
H
Maatouk
CRS Clinical Research Services Mannheim GmbH, Grünstadt, Germany.
Karl Ernst
KE
Siegler
CRS Clinical Research Services Mannheim GmbH, Grünstadt, Germany.
Nadja
N
Faisst
Nephrologisches Zentrum, Rendsburg, Germany.
Volkmar
V
Lufft
Nephrologisches Zentrum, Rendsburg, Germany.
Norbert
N
Klause
DPP-IV inhibitor; MP-513; end stage renal disease; pharmacokinetics; renal impairment; teneligliptin