Influence of renal and hepatic impairment on the pharmacokinetics of anacetrapib

Brett Lauring, Xiujiang Li, Yang Liu, Christy Corr, Nicole Lazarus, Josee Cote, Patrick Larson, Amy O.Johnson Levonas, Kenneth C. Lasseter, Richard A Preston, William B. Smith, Eseng Lai, John A. Wagner

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Two open-label, parallel-group studies evaluated the influence of renal and hepatic insufficiency on the pharmacokinetics of a single-dose anacetrapib 100 mg. Eligible participants included adult men and women with moderate hepatic impairment (assessed by Child-Pugh criteria) or severe renal impairment (CrCl <30 mL/min/1.73 m2). In both studies, patients were matched (race, age, sex, BMI) with healthy control subjects. Twenty-four subjects were randomized in each study (12 with either moderate hepatic or severe renal impairment and 12 matched healthy controls). In the hepatic insufficiency study, the geometric mean ratio (GMR; mean value for the group with moderate hepatic insufficiency/mean value for the healthy controls) and 90% CIs for the area under the concentration-time curve from time zero to infinity (AUC0-) and the maximum concentration of drug in plasma (Cmax) were 1.16 (0.84, 1.60) and 1.02 (0.71, 1.49), respectively. In the renal insufficiency study, the GMRs (mean value for the group with severe renal insufficiency/mean value for the healthy controls) and 90% CIs for AUC0- and Cmax were 1.14 (0.80, 1.63) and 1.31 (0.93, 1.83), respectively. Anacetrapib was generally well tolerated and there was no clinically meaningful effect of moderate hepatic or severe renal insufficiency on the pharmacokinetics of anacetrapib.

Original languageEnglish (US)
Pages (from-to)1247-1255
Number of pages9
JournalJournal of Clinical Pharmacology
Volume54
Issue number11
DOIs
StatePublished - Nov 1 2014

Keywords

  • anacetrapib
  • hepatic
  • insufficiency
  • pharmacokinetics
  • renal

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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