Effect of aprepitant on the pharmacokinetics of intravenous midazolam

J Clin Pharmacol. 2007 Jun;47(6):744-50. doi: 10.1177/0091270007300807. Epub 2007 Apr 26.

Abstract

Oral aprepitant 125 mg, an antiemetic and a moderate inhibitor of the metabolism of oral midazolam, was assessed for interaction with intravenous midazolam in 12 subjects randomized to intravenous midazolam 2 mg +/- oral aprepitant 125 mg. The hypothesis was that midazolam AUC would not change by more than 2-fold (consistent with no more than weak inhibition) when midazolam + aprepitant was compared with midazolam alone. An AUC geometric mean ratio (midazolam + aprepitant/midazolam) with 90% confidence interval upper bound < or =2.0 (an increase in midazolam felt to be of modest clinical significance in the highly monitored perioperative period) was prespecified. Aprepitant increased intravenous midazolam AUC(0-infinity) 1.47-fold (90% confidence interval, 1.36-1.59), which fell within the prespecified criterion.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiemetics / adverse effects
  • Antiemetics / pharmacology*
  • Aprepitant
  • Area Under Curve
  • Cross-Over Studies
  • Cytochrome P-450 CYP3A
  • Cytochrome P-450 Enzyme System / metabolism
  • Female
  • Half-Life
  • Humans
  • Injections, Intravenous
  • Male
  • Metabolic Clearance Rate
  • Midazolam / administration & dosage
  • Midazolam / adverse effects
  • Midazolam / pharmacokinetics*
  • Morpholines / adverse effects
  • Morpholines / pharmacology*

Substances

  • Antiemetics
  • Morpholines
  • Aprepitant
  • Cytochrome P-450 Enzyme System
  • Cytochrome P-450 CYP3A
  • CYP3A4 protein, human
  • Midazolam