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Effect of Aprepitant on the Pharmacokinetics of Intravenous Midazolam

From Merck Research Laboratories, West Point, Pennsylvania (Dr Majumdar, Ms Yan, Ms Selverian, Dr Barlas, Mr Constanzer, Mr Dru, Dr McCrea, Ms Ahmed, Dr Petty), and the Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, Pennsylvania (Dr Frick, Dr Kraft, Dr Greenberg). Howard Greenberg is a member of the American College of Clinical Pharmacology (FCP).

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 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- 1.47-fold (90% confidence interval, 1.36-1.59), which fell within the prespecified criterion.

Key Words: Aprepitant • midazolam • CYP3A4 interaction • intravenous • pharmacokinetics

Address for reprints: Jacqueline McCrea, PharmD, Merck & Co, PO Box 1000, UG4D-48, North Wales, PA 19545; e-mail: jackie_mccrea{at}merck.com.

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