Application of chimeric mice with humanized liver for predictive ADME

Drug Metabolism Reviews

Volumn 39, Issue 1, 2007, Pages 145-157

  Katoh, Miki ^a   Yokoi, Tsuyoshi ^a  

^a KANAZAWA UNIVERSITY   (Japan)

Author keywords

Chimeric mice with humanized liver; Cytochrome P450; Drug metabolism; Enzyme induction; Enzyme inhibition; Excretion; Pharmacokinetics; Phase II enzyme

Indexed keywords

4 HYDROXYDEBRISOQUINE; ACYLTRANSFERASE; CEFMETAZOLE; CYTOCHROME P450; CYTOCHROME P450 1A2; CYTOCHROME P450 2C8; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; DEBRISOQUINE; DEXAMETHASONE; ENZYME; ERYTHROMYCIN; GLUCURONOSYLTRANSFERASE; GLUTATHIONE TRANSFERASE; QUINIDINE; RIFABUTIN; RIFAMPICIN; SULFOTRANSFERASE; UROKINASE;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; CHIMERIC MOUSE WITH HUMANIZED LIVER; CONTROLLED STUDY; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG EXCRETION; DRUG METABOLISM; ENZYME INDUCTION; ENZYME INHIBITION; EVALUATION; FECES; HUMAN; HUMAN CELL; IN VITRO STUDY; IN VIVO STUDY; LIVER METABOLISM; METABOLITE; MOUSE; MOUSE STRAIN; NONHUMAN; ORGAN DONOR; PROTEIN EXPRESSION; RESEARCH; REVIEW; SCID MOUSE; SERUM; STATISTICAL SIGNIFICANCE; URINARY EXCRETION;

ANIMALS; HEPATOCYTES; HUMANS; LIVER; METABOLIC DETOXICATION, PHASE I; METABOLIC DETOXICATION, PHASE II; MICE; PHARMACEUTICAL PREPARATIONS; TRANSPLANTATION CHIMERA; XENOBIOTICS;

EID: 33847013696     PISSN: 03602532     EISSN: 10979883     Source Type: Journal    
DOI: 10.1080/03602530601021340     Document Type: Review

References (45)

1. Bachmann, K. A. (2006). Inhibition constants, inhibitor concentrations and the prediction of inhibitory drug drug interactions: pitfalls, progress and promise. Curr. Drug Metab. 7:1-14.
2. Caporaso, N. E., Shaw, G. L. (1991). Clinical implications of the competitive inhibition of the debrisoquin-metabolizing isozyme by quinidine. Arch. Intern. Med. 151:1985-1992.
3. Corchero, J., Granvil, C. P., Akiyama, T. E., Hayhurst, G. P., Pimprale, S., Feigenbaum, L., Idle, J. R., Gonzalez, F. J. (2001). The CYP2D6 humanized mouse: effect of the human CYP2D6 transgene and HNF4alpha on the disposition of debrisoquine in the mouse. Mol. Pharmacol. 60:1260-1267.
4. Dandri, M., Burda, M. R., Torok, E., Pollok, J. M., Iwanska, A., Sommer, G., Rogiers, X., Rogler, C. E., Gupta, S., Will, H., Greten, H., Petersen, J. (2001). Repopulation of mouse liver with human hepatocytes and in vivo infection with hepatitis B virus. Hepatology. 33:981-988.
5. Dresser, G. K., Spence, J. D., Bailey, D. G. (2000). Pharmacokinetic- pharmacodynamic consequences and clinical relevance of cytochrome P450 3A4 inhibition. Clin. Pharmacokinet. 38:41-57.
6. Eichelbaum, M., Ingelman-Sundberg, M., Evans, W. E. (2006). Pharmacogenomics and individualized drug therapy. Annu. Rev. Med. 57:119-137.
7. 14C N-methyl] erythromycin breath test in healthy male volunteers. J. Clin. Pharmacol. 38:492-495.
8. Gomez-Lechon, M. J., Donato, M. T., Castell, J. V., Jover, R. (2003). Human hepatocytes as a tool for studying toxicity and drug metabolism. Curr. Drug Metab. 4:292-312.
9. Hemeryck, A., Belpaire, F. M. (2002). Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: an update. Curr. Drug Metab. 3:13-37.
10. Hiroi, T., Chow, T., Imaoka, S., Funae, Y. (2002). Catalytic specificity of CYP2D isoforms in rat and human. Drug Metab. Dispos. 30:970-976.
11. Hutzler, M., Messing, D. M., Wienkers, L. C. (2005). Predicting drug-drug interactions in drug discovery: where are we now and where are we going? Curr. Opin. Drug Discov. Devel. 8:51-58.
12. Ingelman-Sundberg, M. (2002). Polymorphism of cytochrome P450 and xenobiotic toxicity. Toxicology. 181-182:447-452.
13. Ingelman-Sundberg, M. (2005). Genetic polymorphisms of cytochrome P450 2D6 (CYP2D6): clinical consequences, evolutionary aspects and functional diversity. Pharmacogenomics J. 5:6-13.
14. Iwasaki, K., Yamato, Y., Emoto, C., Kuroda, M., Soeno, Y., Katoh, M., Horie, T., Yokoi, T., Yoshizato, K. (2005). Induction of cytochrome P450 3A4/5 by rifamycins in chimeric mice with humanized liver. Drug Metab. Rev. 37 suppl 2:143.
15. Karim, A., Kook, C., Zitzewitz, D. J., Zagarella, J., Doherty, M., Campion, J. (1976). Species differences in the metabolism and disposition of spironolactone. Drug Metab. Dispos. 4:547-555.
16. Katoh, M., Matsui, T., Nakajima, M., Tateno, C., Kataoka, M., Soeno, Y., Horie, T., Iwasaki, K., Yoshizato, K., Yokoi, T. (2004). Expression of human cytochromes P450 in chimeric mice with humanized liver. Drug Metab. Dispos. 32:1402-1410.
17. Katoh, M., Matsui, T., Nakajima, M., Tateno, C., Soeno, Y., Horie, T., Iwasaki, K., Yoshizato, K., Yokoi, T. (2005a). In vivo induction of human cytochrome P450 enzymes expressed in chimeric mice with humanized liver. Drug Metab. Dispos. 33:754-763.
18. Katoh, M., Matsui, T., Okumura, H., Nakajima, M., Nishimura, M., Naito, S., Tateno, C., Yoshizato, K., Yokoi, T. (2005b). Expression of human phase II enzymes in chimeric mice with humanized liver. Drug Metab. Dispos. 33:1333-1340.
19. Katoh, M., Watanabe, M., Tabata, T., Sato, Y., Nakajima, M., Nishimura, M., Naito, S., Tateno, C., Iwasaki, K., Yoshizato, K., Yokoi, T. (2005c). In vivo induction of human cytochrome P450 3A4 by rifabutin in chimeric mice with humanized liver. Xenobiotica. 35:863-875.
20. Katoh, M., Sawada, T., Soeno, Y., Nakajima, M., Tateno, C., Yoshizato, K., Yokoi, T. (2007). In vivo drug metabolism model for human cytochrome P450 enzyme using chimeric mice with humanized liver. J. Pharm. Sci. in press.
21. Ko, H., Novak, E., Peters, G. R., Bothwell, W. M., Hosley, J. D., Closson, S. K., Adams, W. J. (1989). Pharmacokinetics of single-dose cefmetazole following intramuscular administration of cefmetazole sodium to healthy male volunteers. Antimicrob. Agents Chemother. 33:508-512.
22. 14C-bumetanide in the rat and their excretion by rats and dogs. Drug Metab. Dispos. 4:169-176.
23. Li, A. P., Maurel, P., Gomez-Lechon, M. J., Cheng, L. C., Jurima-Romet, M. (1997a) Preclinical evaluation of drug-drug interaction potential: present status of the application of primary human hepatocytes in the evaluation of cytochrome P450 induction. Chem. Biol. Interact. 107:5-16.
24. Li, A. P., Reith, M. K., Rasmussen, A., Gorski, J. C., Hall, S. D., Xu, L., Kaminski, D. L., Cheng, L. K. (1997b). Primary human hepatocytes as a tool for the evaluation of structure-activity relationship in cytochrome P450 induction potential of xenobiotics: evaluation of rifampin, rifapentine and rifabutin. Chem. Biol. Interact. 107:17-30.
25. Lin, J. H., Lu, A. Y. (2001). Interindividual variability in inhibition and induction of cytochrome P450 enzymes. Annu. Rev. Pharmacol. Toxicol. 41:535-567.
26. Mahgoub, A., Idle, J. R., Dring, L. G., Lancaster, R., Smith, R. L. (1977). Polymorphic hydroxylation of debrisoquine in man. Lancet. 2:584-586.
27. Masubuchi, Y., Iwasa, T., Hosokawa, S., Suzuki, T., Horie, T., Imaoka, S., Funae, Y., Narimatsu, S. (1997). Selective deficiency of debrisoquine 4-hydroxylase activity in mouse liver microsomes. J. Pharmacol. Exp. Ther. 282:1435-1441.
28. Mercer, D. F., Schiller, D. E., Elliott, J. F., Douglas, D. N., Hao, C., Rinfret, A., Addison, W. R., Fischer, K. P., Churchill, T. A., Lakey, J. R., Tyrrell, D. L., Kneteman, N. M. (2001). Hepatitis C virus replication in mice with chimeric human livers. Nat. Med. 7:927-933.
29. Miners, J. O., McKinnon, R.A., Mackenzie, P. I. (2002). Genetic polymorphisms of UDP-glucuronosyltransferases and their functional significance. Toxicology. 181-182:453-456.
30. Murakawa, T., Sakamoto, H., Fukada, S., Nakamoto, S., Hirose, T., Itoh, N., Nishida, M. (1980). Pharmacokinetics of ceftizoxime in animals after parenteral dosing. Antimicrob. Agents Chemother. 17:157-164.
31. Nagar, S., Remmel, R. P. (2006). Uridine diphosphoglucuronosyltransferase pharmacogenetics and cancer. Oncogene. 25:1659-1672.
32. Nakajima, M., Tane, K., Nakamura, S., Shimada, N., Yamazaki, H., Yokoi, T. (2002). Evaluation of approach to predict the contribution of multiple cytochrome P450s in drug metabolism using relative activity factor: effects of the differences in expression levels of NADPH-cytochrome P450 reductase and cytochrome b5 in the expression system and the differences in the marker activities. J. Pharm. Sci. 91:952-963.
33. Nelson, D. R., Koymans, L., Kamataki, T., Stegeman, J. J., Feyereisen, R., Waxman, D. J., Waterman, M. R., Gotoh, O., Coon, M. J., Estabrook, R. W., Gunsalus, I. C., Nebert, D. W. (1996). P450 superfamily: update on new sequences, gene mapping, accession numbers and nomenclature. Pharmacogenetics. 6:1-42.
34. Niemi, M., Backman, J. T., Fromm, M. F., Neuvonen, P. J., Kivisto, K. T. (2003). Pharmacokinetic interactions with rifampicin: clinical relevance. Clin. Pharmacokinet. 42:819-850.
35. Nishimura, M., Yokoi, T., Tateno, C., Kataoka, M., Takahashi, E., Horie, T., Yoshizato, K., Naito, S. (2005a). Induction of human CYP1A2 and CYP3A4 in primary culture of hepatocytes from chimeric mice with humanized liver. Drug Metab. Pharmacokinet. 20:121-126.
36. Nishimura, M., Yoshitsugu, H., Yokoi, T., Tateno, C., Kataoka, M., Horie, T., Yoshizato, K., Naito, S. (2005b). Evaluation of mRNA expression of human drug-metabolizing enzymes and transporters in chimeric mouse with humanized liver. Xenobiotica. 35:877-890.
37. Pascussi, J. M., Gerbal-Chaloin, S., Daujat, M., Drocourt, L., Pichard-Garcia, L., Vilarem, M. J., Maurel, P., Klieber, S., Torreilles, F., Bourrie, M., Guillou, F., Fabre, G. (2003). CYP gene induction by xenobiotics and drugs. In: J. S. Lee, R. S. Obach, M B. Fisher (eds.), Drug Metabolizing Enzymes. New York: Marcel Dekker. pp. 337-374.
38. Perucca, E., Grimaldi, R., Frigo, G. M., Sardi, A., Mönig, H., Ohnhaus, E. E. (1988). Comparative effects of rifabutin and rifampicin on hepatic microsomal enzyme activity in normal subjects. Eur. J. Clin. Pharmacol. 34:595-599.
39. Robertson, G. R., Field, J., Goodwin, B., Bierach, S., Tran, M., Lehnert, A., Liddle, C. (2003). Transgenic mouse models of human CYP3A4 gene regulation. Mol. Pharmacol. 64:42-50.
40. Rodrigues, A. D., Rushmore, T. H. (2002). Cytochrome P450 pharmacogenetics in drug development: in vitro studies and clinical consequences. Curr. Drug Metab. 3:289-309.
41. Ronis, M. J. J., Ingelman-Sundberg, M. (1999). Induction of human drug metabolizing enzymes: mechanisms and implications. In: T. F. Woolf (ed.), Handbook of Drug Metabolism. New York: Marcel Dekker. pp. 239-262.
42. Tateno, C., Yoshizane, Y., Saito, N., Kataoka, M., Utoh, R., Yamasaki, C., Tachibana, A., Soeno, Y., Asahina, K., Hino, H., Asahara, T., Yokoi, T., Furukawa, T., Yoshizato, K. (2004). Near completely humanized liver in mice shows human-type metabolic responses to drugs. Am. J. Pathol. 165:901-912.
43. Tomlinson, E. S., Maggs, J. L., Park, B. K. Back, D. J. (1997). Dexamethasone metabolism in vitro: species differences. J. Steroid. Biochem. Mol. Biol. 62:345-352.
44. Zhang, W., Purchio, A. F., Chen, K., Wu, J., Lu, L., Coffee, R., Contag, P. R., West, D. B. (2003). A transgenic mouse model with a luciferase reporter for studying in vivo transcriptional regulation of the human CYP3A4 gene. Drug Metab. Dispos. 31:1054-1064.
45. Zhou, S., Chan, S. Y., Goh, B. C., Chan, E., Duan, W., Huang, M., McLeod, H. L. (2005). Mechanism-based inhibition of cytochrome P450 3A4 by therapeutic drugs. Clin. Pharmacokinet. 44:279-304.