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Xenobiotica
the fate of foreign compounds in biological systems
Volume 44, 2014 - Issue 2
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Review Article

Current status of prediction of drug disposition and toxicity in humans using chimeric mice with humanized liver

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Pages 123-134 | Received 13 Nov 2013, Accepted 18 Nov 2013, Published online: 13 Dec 2013

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
  • Azuma H, Paulk N, Ranade A, et al. (2007). Robust expansion of human hepatocytes in Fah−/−/Rag2−/−/II2rg−/− mice. Nature Biotechnol 25:903–10
  • Beedham C. (1985). Molybdenum hydroxylases as drug-metabolizing enzymes. Drug Metabo Rev 16:119–56
  • 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
  • Bissig K-D, Wieland SF, Tran P, et al. (2010). Human liver chimeric mice provide a model for hepatitis B and C virus infection and treatment. J Clin Invest 120:924–30
  • Dandri M, Burda MR, Torok E, et al. (2001). Repopulation of mouse liver with human hepatocytes and in vivo infection with hepatitis B virus. Hepatology 33:981–8
  • de Serres M, Bowers G, Boyle G, et al. (2011). Evaluation of a chimeric (uPA+/+)/SCID mouse model with a humanized liver for prediction of human metabolism. Xenobiotica 41:464–75
  • Emoto, C, Yamato Y, Sato Y, et al. (2008). Non-invasive method to detect induction of CYP3A4 in chimeric mice with a humanized liver. Xenobiotica 38:239–48
  • Garattini E, Mendel R, Romao MJ, et al. (2003). Mammalian molybdo-flavoenzymed, an expanding family of proteins: structure, genetics, regulation, function and pathophysiology. Biochem J 372:15–32
  • Hasegawa M, Kawai K, Mitsui T, et al. (2011). The reconstituted ‘humanized liver’ in TK-NOG mice in mature and functional. Biochem Biophys Res Commun 405:405–10
  • Hasegawa M, Tahara H, Inoue R, et al. (2012). Investigation of drug--drug interactions caused by human pregnane X receptor-mediated induction of CYP3A4 and CYP2C subfamilies in chimeric mice with a humanized liver. Drug Metab Dispos 40:474–80
  • Hu Y, Wu M, Nishimura T, et al. (2013). Human pharmacogenetic analysis in chimeric mice with ‘humanized livers’. Pharmacogenet Genomics 23:78–83
  • 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
  • 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
  • Kakuni M, Morita M, Matsuo K, et al. (2012). Chimeric mice with a humanized liver as an animal model of troglitazone-induced liver injury. Toxicol Lett 214:9–18
  • 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
  • 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
  • Katoh M, Matsui T, Nakajima M, et al. (2005a). In vivo induction of human cytochrome P450 enzymes expressed in chimeric mice with humanized liver. Drug Metab Dispos 33:754–63
  • Katoh M, Matsui T, Okumura H, et al. (2005b). Expression of human phase II enzymes in chimeric mice with humanized liver. Drug Metab Dispos 33:1333–40
  • 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
  • Katoh M, Tateno C, Yoshizato K, Yokoi T. (2008). Chimeric mice with humanized liver. Toxicology 246:9–17
  • Katoh M, Watanabe M, Tabata T, et al. (2005c). In vivo induction of human cytochrome P450 3A4 by rifabutin in chimeric mice with humanized liver. Xenobiotica 35:863–75
  • Katoh M, Yokoi T. (2007). Application of chimeric mice with humanized liver for predictive ADME. Drug Metab Rev 39:145–57
  • 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
  • Kikuchi R, McCown M, Olson P, et al. (2010). Effect of hepatitis C virus infection on the mRNA expression of drug transporters and cytochrome P450 enzymes in chimeric mice with humanized liver. Drug Metab Dispos 38:1954–61
  • 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
  • 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
  • Kitamura S, Sugihara K, Ohta S. (2006). Drug-metabolizing ability of molybdenum hydroxylase. Drug Metab Pharmacokinet 21:83–98
  • 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
  • Liu L, Halladay JS, Shin Y, et al. (2011). Significant species difference in amide hydrolysis of GDC-0834, a novel potent and selective Bruton’s tyrosine kinase inhibitor. Drug Metab Dispos 39:1840–9
  • Lootens L, Meuleman P, Leroux-Roels G, Van Eenoo P. (2011). Metabolic studies with promagnon, methylclostebol and methasterone in the uPA+/+-SCID chimeric mice. J Steroid Biochem Mol Biol 127:374–81
  • 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
  • Lütgehetmann M, Mancke LV, Volz T, et al. (2012). Humanized chimeric uPA mouse model for the study of hepatitis B and D virus interactions and preclinical drug evaluation. Hepatology 55:685–94
  • Mercer DF, Schiller DE, Elliott JF, et al. (2001). Hepatitis C virus replication in mice with chimeric human livers. Nat Med 7:927–33
  • Mueleman P, Libbrecht L, De Vos R, et al. (2005). Morphological and biochemical characterization of a human liver in a uPA-SCID mouse chimera. Hepatology 41:847–56
  • Nakagawa S, Hirata Y, Kameyama T, et al. (2013). Targeted induction of interferon-λ in humanized chimeric mouse liver abrogates hepatotropic virus infection. PLoS ONE 8:1–12
  • Nishimura T, Hu Y, Wu M, et al. (2013). Using chimeric mice with humanized livers to predict human drug metabolism and a drug--drug interaction. J Pharmacol Exp Ther 344:388–98
  • Nishimura M, Yokoi T, Tateno C, et al. (2005a). Induction of human CYP1A2 and CYP3A4 in primary culture of hepatocytes from chimeric mice with humanized liver. Drug Metab Pharmacokinet 20:121–6
  • Nishimura M, Yoshitsugu H, Yokoi T, et al. (2005b). Evaluation of mRNA expression of human drug-metabolizing enzymes and transporters in chimeric mouse with humanized liver. Xenobiotica 35:877–90
  • Obach RS. (2004). Potent inhibition of human liver aldehyde oxidase by raloxifene. Drug Metab Dispos 32:89–97
  • Obach RS, Huynh P, Allen MC, Beedham C. (2004). Human liver aldehyde oxidase: inhibition by 239 drugs. J Clin Pharmacol 44:7–19
  • Ohara E, Hiraga N, Imamura M, et al. (2011). Elimination of hepatitis C virus by short term NS3-4A and NS5B inhibitor combination therapy in human hepatocyte chimeric mice. J Hepatol 54:872–8
  • Okumura H, Katoh M, Sawada T, et al. (2007). Humanization of excretory pathway in chimeric mice with humanized liver. Toxicol Sci 97:533–8
  • Peltz G. (2013). Can ‘humanized’ mice improve drug development in the 21st century? Trends Pharmacol Sci 34:255–60
  • Peterson RA, Krull DL, Brown HR, de Serres M. (2010). Morphologic characterization of PhenixBio (uPA+/+/SCID) humanized liver chimeric mouse model. Drug Metab Lett 4:180–4
  • 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
  • Renwick AB, Mistry H, Ball SE, et al. (1998). Metabolism of zaleplon by human hepatic microsomal cytochrome P450 isoforms. Xenobiotica 28:337–48
  • Samuelsson K, Pickup K, Sarda S, et al. (2012). Pharmacokinetics and metabolism of midazolam in chimeric mice with humanized livers. Xenobiotica 42:1128–37
  • Sanoh S, Horiguchi A, Sugihara K, et al. (2012a). Prediction of in vivo hepatic clearance and half-life of drug candidates using chimeric mice with humanized liver. Drug Metab Dispos 40:322–8
  • Sanoh S, Horiguchi A, Sugihara K, et al. (2012b). Predictability of metabolism of ibuprofen and naproxen using chimeric mice with human hepatocytes. Drug Metab Dispos 40:2267–72
  • Sanoh S, Nozaki K, Murai H, et al. (2012c). Prediction of human metabolism of FK3453 by aldehyde oxidase using chimeric mice transplanted with human or rat hepatocytes. Drug Metab Dispos 40:76–82
  • Sanoh S, Ohta S. (2013). Chimeric mice transplanted with human hepatocytes as a model for prediction of human drug metabolism and pharmacokinetics. Biopharm Drug Dispos, in press. doi:10.1002/bdd.1864
  • Sato Y, Yamada H, Iwasaki K, et al. (2008). Human hepatocytes can repopulate mouse liver: histopathology of the liver in human hepatocyte-transplanted chimeric mice and toxicologic responses to acetaminophen. Toxicol Pathol 36:581–91
  • 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
  • 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
  • Suemizu H, Hasegawa M, Kawai K, et al. (2008). Establishment of a humanized model of liver using NOD/Shi-scid IL2Rgnull mice. Biochem Biophys Res Commun 377:248–52
  • Tanoue C, Sugihara K, Uramaru N, et al. (2013). Prediction of human metabolism of the sedative-hypnotic zaleplon using chimeric mice transplanted with human hepatocytes. Xenobiotica 43:956--62
  • Tateno C, Miya F, Wake K, et al. (2013). Morphological and microarray analyses of human hepatocytes from xenogeneic host livers. Laboratory Invest 93:54–71
  • 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
  • Tsuge M, Fujimoto Y, Hiraga N, et al. (2011). Hepatitis C virus infection suppresses the interferon response in the liver of the human hepatocyte chimeric mouse. PLoS ONE 6:1–14. doi:10.1371/journal.pone.0023856
  • Utoh R, Tateno C, Kataoka M, et al. (2010). Hepatic hyperplasia associated with discordant xenogeneic parenchymal-nonparenchymal interactions in human hepatocyte-repopulated mice. Am J Pathol 177:654–65
  • 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
  • Vaughan AM, Mikolajczak SA, Wilson EM, et al. (2012). Complete Plasmodium falciparum liver-stage development in liver-chimeric mice. J Clin Invest 122:3618–28
  • Watanabe T, Sugauchi F, Tanaka Y, et al. (2012). Hepatitis C virus kinetics by administration of pegylated interferon-α in human and chimeric mice carrying human hepatocytes with variants of the IL28B gene. Gut 62:1–7. doi:10.1136/gutjnl-2012-302553
  • Yamasaki C, Kataoka M, Kato Y, et al. (2010). In vitro evaluation of cytochrome P450 and glucuronidation activities in hepatocytes isolated from liver-humanized mice. Drug Metab Pharmacokinet 25:539–50
  • Yamazaki H, Kuribayashi S, Inoue T, et al. (2010). Approach for in vivo protein binding of 5-n-butyl-pyrazolo[1,5-α]pyrimidine bioactivated in chimeric mice with humanized liver by two-dimensional electrophoresis with accelerator mass spectrometry. Chem Res Toxicol 23:152–8
  • Yamazaki H, Suemizu H, Murayama N, et al. (2013). In vivo drug interactions of the teratogen thalidomide with midazolam: heterotropic cooperativity of human cytochrome P450 in humanized TK-NOG mice. Chem Res Toxicol 26:486–9
  • Yamazaki H, Suemizu H, Shimizu M, et al. (2011). In vivo formation of a glutathione conjugate derived from thalidomide in humanized uPA-NOG mice. Chem Res Toxicol 24:287–9
  • Yamazaki H, Suemizu H, Shimizu M, et al. (2012). In vivo formation of dihydroxylated and glutathione conjugate metabolites derived from thalidomide and 5-hydroxythalidomide in humanized TK-NOG mice. Chem Res Toxicol 25:274–6
  • Yoshizato K, Tateno C. (2009). In vivo modeling of human liver for pharmacological study using humanized mouse. Expert Opin Drug Metab Toxicol 5:1435–46
  • Yoshizato K, Tateno C, Utoh R. (2012). Mice with liver composed of human hepatocytes as an animal model for drug testing. Current Drug Discovery Technol 9:63–76

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