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PIII-61Exenatide does not affect the pharmacokinetics and pharmacodynamics of warfarin in healthy male subjects by SOON, D; KOTHARE, P; LINNEBJERG, H; PARK, S; YUEN, E; MACE, K; CHAN, C; WISE, S is a Medicine article available to read on EtoBox.

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BACKGROUND/AIMS: This study was conducted to evaluate the influence of renal insufficiency (RI) on the pharmacokinetics (PK) of sitagliptin (SIT), a selective DPP-IV inhibitor in Phase III development for the treatment of type 2 diabetes. METHODS: 6 patients/subjects in each of the following groups: mild RI (creatinine clearance (CrCl) ϭ 50 to 80 mL/min), moderate RI (CrCl ϭ 30 to 50 mL/min), severe RI (CrCl Ͻ 30 mL/min) and healthy subjects (CrCl Ͼ 80 mL/min). Each group received a single oral 50-mg dose of SIT. End-stage renal disease (ESRD) patients received 2 single oral 50-mg doses (hemodialysis 4-hr or 48-hr postdose). SIT PK in RI patients was compared to concurrent and historical control subjects. Less than 2-fold increases in AUC 0-ρ were not considered clinically meaningful changes. RESULTS: SIT AUC 0-ρ was approximately inversely related to CrCl. Renal clearance (Cl R ) was approximately proportional to CrCl. AUC 0-ρ increased less than 2-fold for CrCl Ͼ 50 mL/min. AUC 0-ρ was 1.6, 2.3, 3.8 and 4.5-fold higher in mild RI, moderate RI, severe RI and ESRD patients, respectively, compared to healthy subjects. C max was 1.4, 1.4, 1.8 and 1.4 higher in mild moderate and sever

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Author

SOON, D; KOTHARE, P; LINNEBJERG, H; PARK, S; YUEN, E; MACE, K; CHAN, C; WISE, S

Publisher

Nature Publishing Group; Wiley (Blackwell Publishing); Wiley-Blackwell; Wiley; Springer Science and Business Media LLC; Research Square (ISSN 0009-9236)

Published

2006

Language

EN

Field

Medicine (Health Sciences)