Development of an in vivo rat screen model to predict pharmacokinetic interactions of CYP3A4 substrates

References

• Alfaro CL. Emerging role of drug interaction studies in drug development: the good, the bad, and the unknown. Psychopharmacology Bulletin 2001; 35(4)80–93
   PubMedGoogle Scholar
• Backman JT, Karjalainen MJ, Neuvonen M, Laitila J, Neuvonen PJ. Rofecoxib is a potent inhibitor of cytochrome P450 1A2: studies with tizanidine and caffeine in healthy subjects. British Journal of Clinical Pharmacology 2006; 62(3)345–357
   PubMed Web of Science ®Google Scholar
• Bailey DG, Bend JR, Arnold JM, Tran LT, Spence JD. Erythromycin–felodipine interaction: magnitude, mechanism, and comparison with grapefruit juice. Clinical Pharmacology and Therapeutics 1996; 60(1)25–33
   PubMed Web of Science ®Google Scholar
• Balimane PV, Chong S, Morrison RA. Current methodologies used for evaluation of intestinal permeability and absorption. Journal of Pharmacology and Toxicology Methods 2000; 44(1)301–312
   PubMed Web of Science ®Google Scholar
• Balimane PV, Patel K, Marino A, Chong S. Utility of 96 well Caco-2 cell system for increased throughput of P-gp screening in drug discovery. European Journal of Pharmacology and Biopharmacology 2004; 58(1)99–105
   PubMed Web of Science ®Google Scholar
• Barraud de Lagerie S, Comets E, Gautrand C, Fernandez C, Auchere D, Singlas E, Mentre F, Gimenez F. Cerebral uptake of mefloquine enantiomers with and without the P-gp inhibitor elacridar (GF120918) in mice. British Journal of Pharmacology 2004; 141(7)1214–1222
   PubMed Web of Science ®Google Scholar
• Bjornsson TD, Callaghan JT, Einolf HJ, Fischer V, Gan L, Grimm S, Kao J, King SP, Miwa G, Ni L, et al. The conduct of in vitro and in vivo drug–drug interaction studies: a PhRMA perspective. Journal of Clinical Pharmacology 2003; 43(5)443–469
   PubMed Web of Science ®Google Scholar
• Brown CS, Farmer RG, Soberman JE, Eichner SF. Pharmacokinetic factors in the adverse cardiovascular effects of antipsychotic drugs. Clinical Pharmacokinetics 2004; 43(1)33–56
   PubMed Web of Science ®Google Scholar
• Cummins CL, Samphati L, Reid MJ, Benet LZ. In vivo modulation of intestinal CYP3A metabolism by P-glycoprotein: Studies using the rat single-pass intestinal perfusion model. Journal of Pharmacology and Experimental Therapeutics 2003; 305(1)306–314
   PubMed Web of Science ®Google Scholar
• Dambach DM, Andrews BA, Moulin F. New technologies and screening strategies for hepatotoxicity: Use of in vitro models. Toxicology and Pathology 2005; 33(1)17–26
   PubMed Web of Science ®Google Scholar
• Dresser GK, Bailey DG. A basic conceptual and practical overview of interactions with highly prescribed drugs. Canadian Journal of Clinical Pharmacology 2002; 9(4)191–198
   PubMedGoogle Scholar
• Emoto C, Murase S, Iwasaki K. Approach to the prediction of the contribution of major cytochrome P450 enzymes to drug metabolism in the early drug-discovery stage. Xenobiotica 2006; 36(8)671–683
   PubMed Web of Science ®Google Scholar
• Fahey J, Pritchard G, von Moltke LL, Pratt J, Grassi J, Ri S, Greenblatt D. The effects of ketoconazole on triazolam pharmacokinetics, pharmacodynamics and benzodiazepine receptor binding in mice. Journal of Pharmacology and Experimental Therapeutics 1998; 285(1)271–276
   PubMed Web of Science ®Google Scholar
• Ghosal A, Satoh K, Thomas PE, Bush E, Moore D. Inhibition of kinetics of cytochrome P4503A activity in microsomes from rat, human and cDNA-expressed human cytochrome P450. Drug Metabolism and Disposition 1996; 24(9)940–947
   PubMed Web of Science ®Google Scholar
• Gorski JC, Jones DR, Haehner-Daniels BD, Hamman MA, O’Mara EM, Jr, Hall SD. The contribution of intestinal and hepatic CYP3A to the interaction between midazolam and clarithromycin. Clinical Pharmacology and Therapeutics 1998; 64(2)133–143
   PubMed Web of Science ®Google Scholar
• Guengerich FP. Cytochrome P-450 3A4: Regulation and role in drug metabolism. Annual Review of Pharmacology and Toxicology 1999; 39: 1–17
   PubMed Web of Science ®Google Scholar
• Hara Y, Nakajima M, Miyamoto KI, Yokoi T. Inhibitory effects of psychotropic drugs on mexiletine metabolism in human liver microsomes: Prediction of in vivo drug interactions. Xenobiotica 2005; 35(6)549–560
   PubMed Web of Science ®Google Scholar
• Ho RH, Kim RB. Transporters and drug therapy: Implications for drug disposition and disease. Clinical Pharmacology and Therapeutics 2005; 78(3)260–277
   PubMed Web of Science ®Google Scholar
• Honig PK, Wortham DC, Hull R, Zamani K, Smith JE, Cantilena LR. Itraconazole affects single-dose terfenadine pharmacokinetics and cardiac repolarization pharmacodynamics. Journal of Clinical Pharmacology 1993a; 33(12)1201–1206
   PubMed Web of Science ®Google Scholar
• Honig PK, Wortham DC, Zamani K, Conner DP, Mullin JC, Cantilena LR. Terfenadine–ketoconazole interaction. Pharmacokinetic and electrocardiographic consequences. Journal of the American Medical Association 1993b; 269(12)1513–1518
   Web of Science ®Google Scholar
• Hutzler M, Messing DM, Wienkers LC. Predicting drug–drug interactions in drug discovery: where are we now and where are we going?. Current Opinions in Drug Discovery and Development 2005; 8(1)51–58
   PubMedGoogle Scholar
• Ito K, Iwatsubo T, Kanamitsu S, Nakajima Y, Sugiyama Y. Quantitative prediction of in vivo drug clearance and drug interactions from in vitro data on metabolism, together with binding and transport. Annual Reviews in Pharmacology and Toxicology 1998a; 38: 461–499
   PubMed Web of Science ®Google Scholar
• Ito K, Iwatsubo T, Kanamitsu S, Ueda K, Suzuki H, Sugiyama Y. Prediction of pharmacokinetic alterations caused by drug–drug interactions: Metabolic interaction in the liver. Pharmacological Reviews 1998b; 50(3)387–412
   PubMed Web of Science ®Google Scholar
• Jones PH, Davidson MH. Reporting rate of rhabdomyolysis with fenofibrate + statin versus gemfibrozil + any statin. American Journal of Cardiology 2005; 95(1)120–122
   PubMed Web of Science ®Google Scholar
• Kaddoumi A, Fleisher D, Heimbach T, Li LY, Cole S. Factors influencing regional differences in intestinal absorption of UK-343,664 in rat: Possible role in dose-dependent pharmacokinetics. Journal of Pharmaceutical Sciences 2006; 95(2)435–445
   PubMed Web of Science ®Google Scholar
• Kageyama M, Namiki H, Fukushima H, Ito Y, Shibata N, Takada K. In vivo effects of cyclosporin A and ketoconazole on the pharmacokinetics of representative substrates for P-glycoprotein and cytochrome P450 (CYP) 3A in rats. Biology and Pharmacology Bulletin 2005; 28(2)316–322
   PubMed Web of Science ®Google Scholar
• Kanamitsu S, Ito K, Sugiyama Y. Quantitative prediction of in vivo drug–drug interactions from in vitro data based on physiological pharmacokinetics: Use of maximum unbound concentration of inhibitor at the inlet to the liver. Pharmaceutical Research 2000; 17(3)336–343
   PubMed Web of Science ®Google Scholar
• Kanazu T, Okamura N, Yamaguchi Y, Baba T, Koike M. Assessment of the hepatic and intestinal first-pass metabolism of midazolam in a CYP3A drug–drug interaction model rats. Xenobiotica 2005; 35(4)305–317
   PubMed Web of Science ®Google Scholar
• Kanazu T, Yamaguchi Y, Okamura N, Baba T, Koike M. Model for the drug–drug interaction responsible for CYP3A enzyme inhibition. I: Evaluation of cynomolgus monkeys as surrogates for humans. Xenobiotica 2004; 34(5)391–402
   PubMed Web of Science ®Google Scholar
• Kim MJ, Kim H, Cha IJ, Park JS, Shon JH, Liu KH, Shin JG. High-throughput screening of inhibitory potential of nine cytochrome P450 enzymes in vitro using liquid chromatography/tandem mass spectrometry. Rapid Communications in Mass Spectrometry 2005; 19(18)2651–2658
   PubMed Web of Science ®Google Scholar
• Kind AH, Zakowski LJ, McBride PE. Rhabdomyolysis from the combination of a statin and gemfibrozil: An uncommon but serious adverse reaction. Wisconsin Medical Journal 2002; 101(7)53–56
   Google Scholar
• Kivisto KT, Lilja JJ, Backman JT, Neuvonen PJ. Repeated consumption of grapefruit juice considerably increases plasma concentrations of cisapride. Clinical Pharmacology and Therapeutics 1999; 66(5)448–453
   PubMed Web of Science ®Google Scholar
• Kobayashi K, Urashima K, Shimada N, Chiba K. Selectivities of human cytochrome P450 inhibitors toward rat P450 isoforms: Study with cDNA-expressed systems of the rat. Drug Metabolism and Disposition 2003; 31(7)833–836
   PubMed Web of Science ®Google Scholar
• Kotegawa T, Laurijssens BE, Durol AL, Greenblatt DJ. Pharmacokinetics and electroencephalographic effects of ketoconazole in the rat. Biopharmaceutics and Drug Disposition 1999; 20(1)49–52
   PubMed Web of Science ®Google Scholar
• Kotegawa T, Laurijssens BE, Von Moltke LL, Cotreau MM, Perloff MD, Venkatakrishnan K, Warrington JS, Granda BW, Harmatz JS, Greenblatt DJ. In vitro, pharmacokinetics, and pharmacodynamic interactions of ketoconazole and midozolam in the rat. Journal of Pharmacology and Experimental Therapeutics 2002; 302(3)1228–1237
   PubMed Web of Science ®Google Scholar
• Kuroha M, Azumano A, Kuze Y, Shimoda M, Kokue E. Effect of multiple dosing of ketoconazole on pharmacokinetics of midazolam, a cytochrome P450 3A substrate in beagle dogs. Drug Metabolism and Disposition 2002a; 30(1)63–68
   PubMed Web of Science ®Google Scholar
• Kuroha M, Kayaba H, Kishimoto S, Khalil WF, Shimoda M, Kokue E. Effect of oral ketoconazole on first-pass effect of nifedipine after oral administration in dogs. Journal of Pharmaceutical Sciences 2002b; 91(3)868–873
   PubMed Web of Science ®Google Scholar
• Lam YW, Alfaro CL, Ereshefsky L, Miller M. Pharmacokinetic and pharmacodynamic interactions of oral midazolam with ketoconazole, fluoxetine, fluvoxamine, and nefazodone. Journal of Clinical Pharmacology 2003; 43(11)1274–1282
   PubMed Web of Science ®Google Scholar
• Lees RS, Lees AM. Rhabdomyolysis from the coadministration of lovastatin and the antifungal agent itraconazole. New England Journal of Medicine 1995; 333(10)664–665
   PubMed Web of Science ®Google Scholar
• Marathe PH, Rodrigues AD. In vivo animal models for investigating potential CYP3A- and Pgp-mediated drug–drug interactions. Current Drug Metabolism 2006; 7(7)687–704
   PubMed Web of Science ®Google Scholar
• Obach RS, Walsky RL, Venkatakrishnan K, Houston JB, Tremaine LM. In vitro cytochrome P450 inhibition data and the prediction of drug–drug interactions: qualitative relationships, quantitative predictions, and the rank-order approach. Clinical Pharmacology and Therapeutics 2005; 78(6)582–592
   PubMed Web of Science ®Google Scholar
• Ogilvie BW, Zhang D, Li W, Rodrigues AD, Gipson AE, Holsapple J, Toren P, Parkinson A. Glucuronidation converts gemfibrozil to a potent, metabolism-dependent inhibitor of CYP2C8: Implications for drug–drug interactions. Drug Metabolism and Disposition 2006; 34(1)191–197
   PubMed Web of Science ®Google Scholar
• Pea F, Furlanut M. Pharmacokinetic aspects of treating infections in the intensive care unit: Focus on drug interactions. Clinical Pharmacokinetics 2001; 40(11)833–868
   PubMed Web of Science ®Google Scholar
• Persson KP, Ekehed S, Otter C, Lutz ES, McPheat J, Masimirembwa CM, Andersson TB. Evaluation of human liver slices and reporter gene assays as systems for predicting the cytochrome P450 induction potential of drugs in vivo in humans. Pharmacology Research 2006; 23(1)56–59
   PubMed Web of Science ®Google Scholar
• Piquette RK. Torsade de pointes induced by cisapride/clarithromycin interaction. Annals of Pharmacotherapy 1999; 33(1)22–26
   PubMed Web of Science ®Google Scholar
• Rodrigues AD. Integrated cytochrome P450 reaction phenotyping: Attempting to bridge the gap between cDNA-expressed cytochromes P450 and native human liver microsomes. Biochemical Pharmacology 1999; 57(5)465–480
   PubMed Web of Science ®Google Scholar
• Rodrigues AD. Drug–drug interactions. Marcel Dekker, New York 2002
   Google Scholar
• Salphati L, Benet LZ. Effects of ketoconazole on digoxin absorption and disposition in rat. Pharmacology 1998; 56(6)308–313
   PubMed Web of Science ®Google Scholar
• Shitara Y, Hirano M, Sato H, Sugiyama Y. Gemfibrozil and its glucuronide inhibit the organic anion transporting polypeptide 2 (OATP2/OATP1B1: SLC21A6)-mediated hepatic uptake and CYP2C8-mediated metabolism of cerivastatin: analysis of the mechanism of the clinically relevant drug–drug interaction between cerivastatin and gemfibrozil. Journal of Pharmacology and Experimental Therapeutics 2004; 311(1)228–236
   PubMed Web of Science ®Google Scholar
• Stouch TR, Gudmundsson O. Progress in understanding the structure–activity relationships of P-glycoprotein. Advances in Drug Delivery Reviews 2002; 54(3)315–328
   PubMed Web of Science ®Google Scholar
• Tang C, Fang Y, Booth-Genthe C, Kuo Y, Kuduk SD, Rushmore TH, Carr BA. Diclofenac hydroxylation in monkeys: efficiency, regioselectivity, and response to inhibitors. Biochemistry and Pharmacology 2007; 73(6)880–890
   PubMed Web of Science ®Google Scholar
• Thomas AR, Chan LN, Bauman JL, Olopade CO. Prolongation of the QT interval related to cisapride–diltiazem interaction. Pharmacotherapy 1998; 18(2)381–385
   PubMed Web of Science ®Google Scholar
• Thummel KE, Shen DD, Podoll TD, Kunze KL, Trager WF, Hartwell PS, Raisys VA, Marsh CL, McVicar JP, Barr DM, Perkins JD, Carithers RL. Use of midazolam as a human cytochrome P450 3A probe: I. In vitro–in vivo correlations in liver transplant patients. Journal of Pharmacology and Experimental Therapeutics 1994; 271(1)549–556
   PubMed Web of Science ®Google Scholar
• Thummel KE, Wilkinson GR. In vitro and in vivo drug interactions involving human CYP3A. Annual Reviews in Pharmacology and Toxicology 1998; 38: 389–430
   PubMed Web of Science ®Google Scholar
• Tsunoda SM, Velez RL, Von Moltke LL, Greenblatt DJ. Differentiation of intestinal and hepatic cytochrome P450 3A activity with use of midazolam as an in vivo probe: effect of ketoconazole. Clinical Pharmacology and Therapeutics 1999; 66(5)461–471
   PubMed Web of Science ®Google Scholar
• Venkatakrishnan K, Von Moltke LL, Greenblatt DJ. Effects of the antifungal agents on oxidative drug metabolism: clinical relevance. Clinical Pharmacokinetics 2000; 38(2)111–180
   PubMed Web of Science ®Google Scholar
• Wacher VJ, Silverman JA, Zhang Y, Benet LZ. Role of P-glycoprotein and cytochrome P450 3A in limiting oral absorption of peptides and peptidomimetics. Journal of Pharmaceutical Sciences 1998; 87(11)1322–1330
   PubMed Web of Science ®Google Scholar
• Wang EJ, Lew K, Casciano CN, Clement RP, Johnson WW. Interaction of common azole antifungals with P glycoprotein. Antimicrobial Agents and Chemotherapy 2002; 46(1)160–165
   PubMed Web of Science ®Google Scholar
• Ward KW, Stelman GJ, Morgan JA, Zeigler KS, Azzarano LM, Kehler JR, McSurdy-Freed JE, Proksch JW, Smith BR. Development of an in vivo preclinical screen model to estimate absorption and first-pass hepatic extraction of xenobiotics. II. Use of ketoconazole to identify P-glycoprotein/CYP3A-limited bioavailability in the monkey. Drug Metabolism and Disposition 2004; 32(2)172–177
   PubMed Web of Science ®Google Scholar
• Williams JA, Bauman J, Cai H, Conlon K, Hansel S, Hurst S, Sadagopan N, Tugnait M, Zhang L, Sahi J. In vitro ADME phenotyping in drug discovery: Current challenges and future solutions. Current Opinions in Drug Discovery and Development 2005; 8(1)78–88
   PubMedGoogle Scholar
• Yamano K, Yamanoto K, Kotaki K, Sawada Y, Iga T. Quantitative prediction of metabolic inhibition of midazolam by itraconazole and ketoconazole in rats: Implication of concentrative uptake of inhibitors of into liver. Drug Metabolism and Disposition 1999; 27(3)395–402
   PubMed Web of Science ®Google Scholar
• Yamazaki M, Akiyama S, Ni’inuma K, Nishigaki R, Sugiyama Y. Biliary excretion of pravastatin in rats: Contribution of the excretion pathway mediated by canalicular multispecific organic anion transporter. Drug Metabolism and Disposition 1997; 25(10)1123–1129
   PubMed Web of Science ®Google Scholar
• Yamreudeewong W, DeBisschop M, Martin LG, Lower DL. Potentially significant drug interactions of class III antiarrhythmic drugs. Drug Safety 2003; 26(6)421–438
   PubMed Web of Science ®Google Scholar
• Yasuda K, Lan LB, Sanglard D, Furuya K, Schuetz JD, Schuetz EG. Interaction of cytochrome P450 3A inhibitors with P-glycoprotein. Journal of Pharmacology and Experimental Therapeutics 2002; 303(1)323–332
   PubMed Web of Science ®Google Scholar
• Yu DK. The contribution of P-glycoprotein to pharmacokinetic drug–drug interactions. Journal of Clinical Pharmacology 1999; 39(12)1203–1211
   PubMed Web of Science ®Google Scholar
• Zhang H, Zhang D, Li W, Yao M, D’Arienzo C, Li YX, Ewing WR, Gu Z, Zhu Y, Murugesan N, et al. Reduction of site-specific CYP3A-mediated metabolism for dual angiotensin and endothelin receptor antagonists in various in vitro systems and in cynomolgus monkeys. Drug Metabolism and Disposition 2007; 35(5)795–805
   PubMed Web of Science ®Google Scholar