Prediction of human metabolism of the sedative-hypnotic zaleplon using chimeric mice transplanted with human hepatocytes

References

• Aoki K, Kashiwagura Y, Horie T, et al. (2006). Characterization of humanized liver from chimeric mice using coumarin as a human CYP2A6 and mouse CYP2A5 probe. Drug Metab Pharmacokinet 21:277–85
   PubMed Web of Science ®Google Scholar
• Beedham C. (1985). Molybdenum hydroxylases as drug-metabolizing enzymes. Drug Metab Rev 16:119–56
   PubMed Web of Science ®Google Scholar
• Beer B, Ieni JR, Wu WH, et al. (1994). A placebo-controlled evaluation of single, escalating doses of CL-284,846, a non-benzodiazepine hypnotic. J Clin Pharmacol 34:335–44
   PubMed Web of Science ®Google Scholar
• Chaudhary I, DeMaio W, Kantrowitz J. (1994). Species comparison of in vitro and in vivo metabolism of CL284,846, a non-benzodiazepine sedative/hypnotic agent. Pharm Rev (NY) 11:319
   Google Scholar
• Garattini E, Mendel R, Romao MJ, et al. (2003). Mammalian molybdo-flavoenzymes, an expanding family of proteins: structure, genetics, regulation, function and pathophysiology. Biochem J 372:15–32
   PubMed Web of Science ®Google Scholar
• Inoue T, Nitta K, Sugihara K, et al. (2008). CYP2C9-catalyzed metabolism of S-warfarin to 7-hydroxywarfarin in vivo and in vitro in chimeric mice with humanized liver. Drug Metab Dispos 36:2429–33
   PubMed Web of Science ®Google Scholar
• Inoue T, Sugihara K, Ohshita H, et al. (2009). Prediction of human disposition toward S-3H-warfarin using chimeric mice with humanized liver. Drug Metab Pharmacokinet 24:153–60
   PubMed Web of Science ®Google Scholar
• Kamimura H, Nakada N, Suzuki K, et al. (2010). Assessment of chimeric mice with humanized liver as a tool for predicting circulating human metabolites. Drug Metab Pharmacokinet 25:223–35
   PubMed Web of Science ®Google Scholar
• Katoh M, Matsui T, Nakajima M, et al. (2004). Expression of human cytochromes P450 in chimeric mice with humanized liver. Drug Metab Dispos 32:1402–10
   PubMed Web of Science ®Google Scholar
• Katoh M, Matsui T, Nakajima M, et al. (2005b). In vivo induction of human cytochrome P450 enzymes expressed in chimeric mice with humanized liver. Drug Metab Dispos 33:754–63
   PubMed Web of Science ®Google Scholar
• Katoh M, Matsui T, Okumura H, et al. (2005a). Expression of human phase II enzymes in chimeric mice with humanized liver. Drug Metab Dispos 33:1333–40
   PubMed Web of Science ®Google Scholar
• Katoh M, Sawada T, Soeno Y, et al. (2007). In vivo drug metabolism model for human cytochromes P450 enzyme using chimeric mice with humanized liver. J Pharm Sci 96:428–37
   PubMed Web of Science ®Google Scholar
• Katoh M, Tateno C, Yoshizato K, et al. (2008). Chimeric mice with humanized liver. Toxicology 246:9–17
   PubMed Web of Science ®Google Scholar
• Katoh M, Yokoi T. (2007). Application of chimeric mice with humanized liver for predictive ADME. Drug Metab Rev 39:145–57
   PubMed Web of Science ®Google Scholar
• Kawashima K, Hosoi K, Naruke T, et al. (1999). Aldehyde oxidase-dependent marked species difference in hepatic metabolism of the sedative-hypnotic, zaleplon, between monkeys and rats. Drug Metab Dispos 27:422–8
   PubMed Web of Science ®Google Scholar
• Kitamura S, Nitta K, Tayama Y, et al. (2008). Aldehyde oxidase-catalyzed metabolism of N1-methylnicotinamide in vivo and in vitro in chimeric mice with humanized liver. Drug Metab Dispos 36:1202–5
   PubMed Web of Science ®Google Scholar
• Kitamura S, Sugihara K, Nakatami K, et al. (1999). Variation of hepatic methotrexate 7-hydroxylase activity in animals and humans. IUBMB Life 48:607–11
   PubMed Web of Science ®Google Scholar
• Kitamura S, Sugihara K, Ohta S. (2006). Drug-metabolizing ability of molybdenum hydroxylase. Drug Metab Pharmacokinet 21:83–98
   PubMed Web of Science ®Google Scholar
• Lake BG, Ball SE, Kao J, et al. (2002). Metabolism of zaleplon by human liver: evidence for involvement of aldehyde oxidase. Xenobiotica 32:835–47
   PubMed Web of Science ®Google Scholar
• Lootens L, Meuleman P, Leroux-Roels G, et al. (2011). Metabolic studies with promagnon, methylclostebol and methasterone in the uPA+/+-SCID chimeric mice. J Steroid Biochem Mol Biol 127:374–81
   PubMed Web of Science ®Google Scholar
• Lootens L, Meuleman P, Pozo OJ, et al. (2009). uPA+/+-SCID mouse with humanized liver as a model for in vivo metabolism of exogenous steroids: methandienone as a case study. Clin Chem 55:1783–93
   PubMed Web of Science ®Google Scholar
• Nishimura M, Yokoi T, Tateno C, et al. (2005). Induction of human CYP1A2 and CYP3A4 in primary culture of hepatocytes from chimeric mice with humanized liver. Drug Metab Pharmacokinet 20:121–6
   PubMedGoogle Scholar
• Obach RS. (2004). Potent inhibition of human liver aldehyde oxidase by raloxifene. Drug Metab Dispos 32:89–97
   PubMed Web of Science ®Google Scholar
• Obach RS, Huynh P, Allen MC, et al. (2004). Human liver aldehyde oxidase: inhibition by 239 drugs. J Clin Pharmacol 44:7–19
   PubMed Web of Science ®Google Scholar
• Pryde DC, Dalvie D, Hu Q, et al. (2010). Aldehyde oxidase: an enzyme of emerging importance in drug discovery. J Med Chem 53:8441–60
   PubMed Web of Science ®Google Scholar
• Radl S, Blahovcova M, Placek L, et al. (2010). Synthesis of some impurities and/or degradation products of zaleplon. J Heterocyclic Chem 47:276–83
   Google Scholar
• Renwick AB, Ball SE, Tredger JM, et al. (2002). Inhibition of zaleplon metabolism by cimetidine in the human liver: in vitro studies with subcellular fractions and precision-cut liver slices. Xenobiotica 32:849–62
   PubMed Web of Science ®Google Scholar
• Renwick AB, Mistry H, Ball SE, et al. (1998). Metabolism of zaleplon by human hepatic microsomal cytochrome P450 isoforms. Xenobiotica 28:337–48
   PubMed Web of Science ®Google Scholar
• Rosen AS, Fournie P, Darwish M, et al. (1999). Zaleplon pharmacokinetics and absolute bioavailability. Biopharm Drug Dispos 20:171–75
   PubMed Web of Science ®Google Scholar
• Samuelsson K, Pickup K, Sarda S, et al. (2012). Pharmacokinetics and metabolism of midazolam in chimeric mice with humanized livers. Xenobiotica 42:1128–37
   PubMed Web of Science ®Google Scholar
• Sanoh S, Horiguchi A, Sugihara K, et al. (2012b). Prediction of in vivo hepatic clearance and half-life of drug candidates using chimeric mice with humanized liver. Drug Metab Dispos 40:322–8
   PubMed Web of Science ®Google Scholar
• Sanoh S, Horiguchi A, Sugihara K, et al. (2012c). Predictability of metabolism of ibuprofen and naproxen using chimeric mice with human hepatocytes. Drug Metab Dispos 40:2267–72
   PubMed Web of Science ®Google Scholar
• Sanoh S, Nozaki K, Murai H, et al. (2012a). Prediction of human metabolism of FK3453 by aldehyde oxidase using chimeric mice transplanted with human or rat hepatocytes. Drug Metab Dispos 40:76–82
   PubMed Web of Science ®Google Scholar
• Schulz-Utermoehl T, Sarda S, Foster JR, et al. (2012). Evaluation of the pharmacokinetics, biotransformation and hepatic transporter effects of troglitazone in mice with humanized livers. Xenobiotica 42:503–17
   PubMed Web of Science ®Google Scholar
• Strom SC, Davila J, Grompe M. (2010). Chimeric mice with humanized liver: tools for the study of drug metabolism, excretion, and toxicity. Methods Mol Biol 640:491–509
   PubMedGoogle Scholar
• Sugihara K, Katsuma Y, Kitamura S, et al. (2000). Cynomolgus monkey liver aldehyde oxidase: extremely high oxidative activity and an attempt at purification. Comp Biochem Physiol (C) 126:53–60
   PubMed Web of Science ®Google Scholar
• Sugihara K, Kitamura S, Tatsumi K, et al. (1997). Differences in aldehyde oxidase activity in cytosolic preparations of human and monkey liver. Biochem Mol Biol Int 41:1153–60
   PubMedGoogle Scholar
• Tateno C, Yoshizane Y, Saito N, et al. (2004). Near completely humanized liver in mice shows human-type metabolic responses to drugs. Am J Pathol 165:901–12
   PubMed Web of Science ®Google Scholar
• Vanover KE, Barret JE. (1994). Evaluation of the discriminative stimulus effects of the novel sedative-hypnotic CL284,846. Psychopharmacology 115:289–96
   PubMed Web of Science ®Google Scholar
• Vanover KE, Mangano RM, Barret JE. (1994). CL284,846, a novel sedative-hypnotic: evaluation of its metabolites for pharmacological activity in vitro and in vivo. Drug Dev Res 33:39–45
   Web of Science ®Google Scholar
• Wu WH. (1996). Mass balance and pharmacokinetics of zaleplon, a non-benzodiazepine sedative/hypnotic, in man. Pharmaceutical Res 13:S487
   Google Scholar