Preclinical evaluation of drug-drug interaction potential: Present status of the application of primary human hepatocytes in the evaluation of cytochrome P450 induction

Chemico-Biological Interactions

Volumn 107, Issue 1-2, 1997, Pages 5-16

  Li, Albert P ^a   Maurel, Patrick ^b   Gomez Lechon, Maria Jose ^c   Cheng, Larry C ^d   Jurima Romet, Malle ^e  

^a In Vitro Technologies Inc   (United States)

^b CNRS   (France)

^c HOSPITAL UNIVERSITARIO LA FE   (Spain)

^d SANOFI   (France)

^e Bureau of Drug Research   (Canada)

Author keywords

Cytochrome P450; Drug drug interactions; Hepatocytes; Human; Induction

Indexed keywords

3 METHYLCHOLANTHRENE; ALCOHOL; AZATADINE; CARBAMAZEPINE; CYCLOSPORIN; CYTOCHROME P450; DEXAMETHASONE; ISOPENTYL ALCOHOL; LANSOPRAZOLE; METYRAPONE; OMEPRAZOLE; OXOMEMAZINE; PHENOBARBITAL; PHENYLBUTAZONE; PHENYTOIN; PREDNISONE; RIFAMPICIN; SULFADIMIDINE; SULFINPYRAZONE; VIRGINIAMYCIN;

CONFERENCE PAPER; DRUG EFFECT; DRUG RESEARCH; ENZYME INDUCTION; ENZYME INHIBITION; HUMAN; HUMAN CELL; LIVER CELL; LIVER CELL CULTURE;

CELLS, CULTURED; CYTOCHROME P-450 ENZYME SYSTEM; DRUG EVALUATION, PRECLINICAL; DRUG INTERACTIONS; ENZYME INDUCTION; HUMANS; ISOENZYMES; LIVER;

STAPHYLOCOCCUS PHAGE 3A;

EID: 0030726508     PISSN: 00092797     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0009-2797(97)00070-7     Document Type: Conference Paper

References (51)

1. A.P. Li, D.L. Kaminski, A. Rasmussen, Substrates of human hepatic cytochrome P4503A4, Toxicology 104 (1995) 1-8.
2. D. Reimers, L. Nocke-Finck, H. Breuer, Rifampicin and the 'pill' do not go well together, J. Am. Med. Assoc. 227 (1974) 608.
3. D. Janz, D. Schmidt, Antiepileptika und die sicherheit oraler kontraceptiva, Bibl. Psychiatr. 151 (1975) 82-84.
4. G.F. Cooney, M. Mochon, B. Kaiser, S.P. Dunn, B. Goldsmith, Effects of carbamazepine on cyclosporine metabolism in pediatric renal transplant recipients, Pharmacotherapy 15 (1995) 353-356.
5. M.F. Herbert, J.P. Roberts, T. Prueksaritanont, L.Z. Benet, Bioavailability of cyclosporine with concomitant rifampin administration is markedly less than predicted by hepatic enzyme induction, Clin. Pharmacol. Ther. 52 (5) (1992) 453-457.
6. E. Zylberz-Katz, Multiple drug interactions with cyclosporine in a heart transplant patient, Ann. Pharmacother. 29 (2) (1995) 127-131.
7. D.L. Freeman, A. Laupacis, P.A. Keown, C.R. Stiller, S.G. Carruthers, Evaluation of cyclosporin-phenytoin interaction with observations on cyclosporin metabolites, Br. J. CHn. Pharmacol. 18 (1984) 887-893.
8. M.J. D'Souza, S.H. Pollock, H.M. Solomon, Cyclosporin-phenytoin interaction, Drug Metab. Dispos. 16 (2) (1988) 256-258.
9. F.J. Gonzalez, The molecular biology of cytochrome P450s, Pharmacol. Rev. 40 (1989) 243-288.
10. M. Strolin-Benedetti, P. Dostert, Induction and autoinduction properties of rifamycin derivatives, Environ. Health Perspect. 102 (1994) 101-105.
11. T.A. Kocarek, E.G. Schuetz, S.C. Strom, R.A. Fisher, P.S. Guzelian, Comparative analysis of cytochrome P4503A induction in primary cultures of rat, rabbit, and human hepatocytes, Drug Metab. Dispos. 23 (1995) 415-421.
12. M. Daujat, L. Pichard, T. Pineau, G. Fabre, C. Bonfils, P. Maurel, Induction protocols for cytochromes P450IIIA in vivo and in primary cultures of animal and human hepatocytes, Methods Enzymol. 206 (1991) 345-353.
13. M. Daujat, B. Peryt, P. Lesca, G. Fourtanier, J. Domergue, P. Maurel, Omeprazole, an inducer of human CYP1A1 and 1A2, is not a ligand for the Ah receptor, Biochem. Biophys. Res. Commun. 188 (1992) 820-825.
14. M.T. Donato, N.V. Castell, M.J. Gomez-Lechon, Effect of model inducers on cytochrome P450 activities of human hepatocytes in primary culture, Drug Metab. Dispos. 23 (1995) 553-558.
15. A.P. Li, Primary human hepatocytes as an experimental system in toxicology and drug metabolism. Comments Toxicol. (1997) in press.
16. A.P. Li, Evaluation of drug-drug interactions in primary human hepatocytes, in: A.P. Li (Ed.), Drug-drug interactions - Scientific and Regulatory Perspectives, Academic Press, 1997, in press.
17. S.C. Strom, L.A. Pisarov, K. Dorko, M.T. Thompson, J.D. Schuetz, E.G. Schuetz, Use of human hepatocytes to study P450 gene induction, Methods Enzymol 272 (1996) 388-401.
18. S. Strom, R.L. Jirtle, R.S. Jones, D.L. Novicki, M.R. Rosenberg, A. Novotny, G. Irons, J.R. McLain, G. Michalopoulos, Isolation, culture, and transplantation of human hepatocytes, J. Natl. Cancer Inst. 68 (1982) 771-778.
19. H. Maekubo, S. Ozaki, B. Mitmaker, N. Kalant, Preparation of human hepatocytes from primary culture, In Vitro 18 (1982) 483-491.
20. L.J. Loretz, A.P. Li, M.W. Flye, A.G.E. Wilson, Optimization of cryopreservation procedures for rat and human hepatocytes, Xenobiotica 19 (1989) 489-498.
21. D. Diaz, I. Fabre, M. Daujat, B. Saint Aubert, P. Bories, H. Michel, P. Maurel, Omeprazole is an aryl hydrocarbon-like inducer of human hepatic cytochrome P450, Gastroenterology 99 (1990) 737-747.
22. M.J. Gomez-Lechon, P. Lopez, T. Donato, A. Montoya, P. Larrauri, P. Gimenez, R. Trullenque, R. Fabra, J.V. Castell, Culture of human hepatocytes from small surgical liver biopsies. Biochemical characterization and comparison with in vivo., In Vitro Cell. Dev. Biol. 26 (1990) 67-74.
23. A.P. Li, M.A. Roque, D.J. Beck, D.L. Kaminski, Isolation and culturing of hepatocytes from human liver, J. Tissue Culture Methods 14 (1992) 139-146.
24. M.N. Berry, D.S. Friend, High yield preparation of isolated rat liver parenchymal cells, J. Cell Biol. 43 (1969) 506-520.
25. P.O. Seglen, Preparation of isolated rat liver cells, Methods Cell Biol. XIII (1976) 29-83.
26. B.L. Kreamer, J.L. Staecker, N. Sawada, G.L. Sattler, M.T.S. Hsia, H.C. Pitot, Use of a low-speed iso-density Percoll centrifugation method to increase the viability of isolated hepatocyte preparations, In Vitro 22 (1986) 201.
27. J. Muntane-Relat, J.C. Ourlin, J. Domergue, P. Maurel, Differential effects of cytokines on the inducible expression of CYP1A1, CYP1A2 and CYP3A4 in human hepatocytes in primary culture, Hepatology 22 (1995) 1143-1153.
28. L. Pichard, G. Gillet, I. Fabre, I. Dalet-Beluche, C. Bonfils, J.P. Thenot, P. Maurel, Cyclosporin A drug interactions. Screening for inducers and inhibitors of cytochrome P-450 (cyclosporin A oxidase) in primary cultures of human hepatocytes and in liver microsomes, Drug Metab. Dispos. 18 (1990) 595-606.
29. L. Pichard, I. Fabre, M. Daujat, J. Domergue, H. Joyeux, P. Maurel, Effect of corticosteroids on the expression of cytochromes P450 and on cyclosporin A oxidase activity in primary cultures of human hepatocytes, Mol. Pharmacol. 41 (1992) 1047-1055.
30. M. Strolin-Benedetti, P. Dostert, Induction and autoinduction properties of rifamycin derivatives: a review of human and animal studies, Environ. Health Perspect 102 (1994) 101-105.
31. K. Kashfi, C.J. McDougall, A.J. Dannenberg, Comparative effects of omeprazole on xenobiotic metabolizing enzymes in rat and human, Clin. Pharmacol. Ther. 58 (1995) 625-630.
32. J.C. Merrill, D.J. Beck, D.A. Kaminski, A.P. Li, Polybrominated biphenyl induction of cytochrome P450 mixed function oxidase activity in primary rat and human hepatocytes, Toxicology 99 (1995) 147-152.
33. D. Schrenk, T. Stuven, G. Gohl, R. Viebahn, K.W. Bock, Induction of CYP1A and glutathione S-transferase activities by 2,3,7,8-tetrachlorodibenzo-p-dioxin in human hepatocyte cultures, Carcinogenesis 16 (1995) 943-946.
34. I. Dalet-Beluche, X. Boulenc, G. Fabre, P. Maurel, C. Bonfils, Purification of two cytochrome P450 isozymes related to CYP2A and CYP3A gene families from monkey (baboon, Papio papio) liver microsomes. Cross-reactivity with human forms, Eur. J. Biochem. 204 (1992) 641-648.
35. T.K.H. Chang, P. Maurel, D.J. Waxman, Enhanced activation of cyclophosphamide and ifosphamide in primary cultures of human hepatocytes treated with various inducers of CYP2B, CYP2C and CYP3A. Proceedings of the International Congress of Toxicology-VII, Seattle, WA, July 2-6, 1995,
36. F. Morel, P.H. Beaune, D. Ratanasavanh, J.P. Flinois, C.S. Yang, F.P. Guengerich, A. Guillouzo, Expression of cytochrome P450 enzymes in cultured human hepatocytes, Eur. J. Biochem. 191 (1990) 437-444.
37. A. Abid, N. Sabolovic, A.M. Batt, G. Siest, P. Maurel, F. Guillemin, J. Magdalou, Induction of UDP-glucuronosyltransferases and cytochromes P450 in human hepatocytes, Cell. Pharmacol. 1 (1994) 257-262.
38. J.B. Houston, Utility of in vitro drug metabolism data in predicting in vivo metabolic clearance, Biochem. Pharmacol. 47 (1994) 1469-1479.
39. M.H. Grant, S.J. Duthie, A.G. Gray, M.D. Burke, Mixed function oxidase and UDP-glucuronyl-transferase activities in the human HepG2 hepatoma cell line, Biochem. Pharmacol. 37 (1988) 4111-4116.
40. A.L. Roe, J.E. Snawder, R.W. Benson, D.W. Roberts, D.A. Casciano, HepG2 cells: An in vitro model for P450-dependent metabolism of acetaminophen, Biochem. Biophys. Res. Commun. 190 (1993) 15-19.
41. E.G. Schuetz, J.D. Schuetz, S.C. Strom, M.T. Thompson, R.A. Fisher, D.T. Molowa, D. Li, P.S. Guzelian, Regulation of human liver cytochrome P450 in family 3A in primary and continuous culture of human hepatocytes, Hepatology 18 (1993) 1254-126242.
42. C.E. Ruegg, P.M. Silber, R.A. Mughal, J. Ismail, A.P. Li, P450 induction in primary human hepatocytes after cryopreservation. In Vitro Toxicol. (1970) in press.
43. D.M. Burger, P.L. Meenhorst, C.H.H. ten Napel, J.W. Mulder, C. Neef, C.H.W. Koks, A. Bult, J.H. Beijnen, Pharmacokinetic variability of zidovudine in HIV-infected individuals: Subgroup analysis and drug interactions, AIDS 8 (1994) 1683-1689.
44. R. Curi-Pedrosa, M. Daujat, L. Pichard, J.C. Ourlin, P. Clair, L. Gervot, P. Lesca, J. Domergue, H. Joyeux, G. Fourtanier, et al., Omeprazole and lansoprazole are mixed inducers of CYP1A and CYP3A, J. Pharmacol. Exp. Ther. 269 (1994) 384-392.
45. M.T. Donato, M.J. Gomez-Lechon, J.V. Castell, Effect of xenobiotics on monoxygenase activities in cultured human hepatocytes, Biochem. Pharmacol. 39 (1990) 1321-1326.
46. V.E. Kostrubsky, S.C. Strom, S.G. Wood, S.A. Wrighton, P.R. Sinclair, J.F. Sinclair, Ethanol and isopentanol increase CYP3A and CYP2E in primary cultures of human hepatocytes, Arch Biochem. Biophys. 322 (1995) 516-520.
47. A.P. Li, A. Rasmussen, L. Xu, D.L. Kaminski, Rifampincin induction of lidocaine metabolism in cultured human hepatocytes, J. Pharmacol. Exp. Ther. 274 (1995) 673-677.
48. N. Masubuchi, O. Okazaki, A.P. Li, An evaluation of the cytochrome P450 induction potential of pantoprazole in primary human hepatocytes, 1997 (in preparation).
49. L. Pichard, J. Domergue, G. Fourtanier, P. Koch, H.F. Schran, P. Maurel, Metabolism of the new immunosuppressor cyclosporin G by human liver cytochromes P450, Biochem. Pharmacol. 51 (1996) 591-598.
50. L. Xu, A. Li, D. Kaminski, M.F. Ruh, The effects of dioxins on cultured human and rat hepatocytes, Toxicologist (Abstract) 36 (1997) 217.
51. M.C. Wright, P. Maurel, A.J. Paine, Induction of cytochrome P450 3A by metyrapone in human hepatocyte in culture, Hum. Exp. Toxicol. 15 (1996) 203-204.