The chimpanzee (pan troglodytes) as a pharmacokinetic model for selection of drug candidates: Model characterization and application

Drug Metabolism and Disposition

Volumn 32, Issue 12, 2004, Pages 1359-1369

  Wong, Harvey ^a,b   Grossman, Scott J ^b   Bai, Stephen A ^b   Diamond, Sharon ^a,c   Wright, Matthew R ^b   Grace Jr , James E ^b   Qian, Mingxin ^b   He, Kan ^b   Yeleswaram, Krishnaswamy ^a,c   Christ, David D ^a,d  

^a BRISTOL MYERS SQUIBB   (United States)

^b Incyte Corporation ^*

^c Experimental Station   (United States)

^d ADOLOR CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

(2 CYCLOPENTYL 6,7 DICHLORO 2 METHYL 1 OXO 5 INDANYLOXY)ACETIC ACID; 1 (3 AMINO 5 INDAZOLYL) 4,7 DIBENZYL 3 BUTYL 2,3,4,5,6,7 HEXAHYDRO 5,6 DIHYDROXY 2H 1,3 DIAZEPIN 2 ONE; 1 [3 (AMINOMETHYL)PHENYL] N [3 FLUORO 2' (METHYLSULFONYL)[1,1' BIPHENYL] 4 YL] 3 (TRIFLUOROMETHYL) 1H PYRAZOLE 5 CARBOXAMIDE; 2 FLUOROSPIRO[FLUORENE 9,4' IMIDAZOLIDINE] 2',5' DIONE; 3 AMINO 3 METHYL N [2,3,4,5 TETRAHYDRO 2 OXO 1 [[2' (1H TETRAZOL 5 YL) 1,1' BIPHENYL 4 YL]METHYL] 1H 1 BENZAZEPIN 3 YL]BUTANAMIDE; 6 CHLORO 4 (2 CYCLOPROPYLVINYL) 3,4 DIHYDRO 4 TRIFLUOROMETHYL 2(1H) QUINAZOLINONE; CASPOFUNGIN; CEFTRIAXONE; CILASTATIN; CYTOCHROME P450; CYTOCHROME P450 1A2; CYTOCHROME P450 2B6; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; DEALKYLVERAPAMIL; DEXTROMETHORPHAN; DMP 961; DPC 333; DPC 681; DPC 974; DPC A78277; DPC R1; EFAVIRENZ; ERTAPENEM; IMIPENEM; IMIRESTAT; MOZENAVIR; PARACETAMOL; PHENACETIN O DEETHYLASE; PROPRANOLOL; TESTOSTERONE DERIVATIVE; THEOPHYLLINE; TOLBUTAMIDE; UNINDEXED DRUG; VERAPAMIL;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; CHIMPANZEE; CONTROLLED STUDY; CORRELATION ANALYSIS; DOG; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG METABOLISM; DRUG PROTEIN BINDING; ENZYME ACTIVITY; HUMAN; HUMAN CELL; HUMAN TISSUE; HYDROXYLATION; IN VITRO STUDY; INDIVIDUALITY; LIVER CLEARANCE; LIVER MICROSOME; MONKEY; NONHUMAN; PRIORITY JOURNAL; SPECIES DIFFERENCE; STATISTICAL SIGNIFICANCE; SYSTEMIC CIRCULATION;

ANIMALIA; CANIS FAMILIARIS; CHANDIPURA VIRUS; PAN TROGLODYTES; TROGLODYTES;

EID: 9444234586     PISSN: 00909556     EISSN: None     Source Type: Journal    
DOI: 10.1124/dmd.104.000943     Document Type: Article

References (50)

1. Ausubel FM, Brent R, Kinfston RE, Moore DD, Seidman JG, Smith JA, and Struhl K (1994) Current Protocols in Molecular Biology, Green Publishing Associates and Wiley-Interscience, New York.
2. Bailey DN (2001) Effect of coadministered drugs and ethanol on the binding of therapeutic drugs to human serum in vitro. Ther Drug Monit 23:71-74.
3. Benet LZ, Oie S, and Schwartz JB (1996) Design and optimization of dosage regimens: pharmacokinetic data, in Goodman & Gilman's The Pharmacological Basis of Therapeutics, 9th ed (Harman JG, Limbird LE, Molinoff PB, Ruddon RW, and Gilman A eds) pp 1707-1792, McGraw-Hill, New York.
4. Brazzell RK, Park YH, Wooldridge CB, McCue B, Barker R, Couch R, and York B (1990) Interspecies comparison of the pharmacokinetics of aldose reductase inhibitors. Drug Metab Dispos 18:435-440.
5. Budavari S (editor) (1996) The Merck Index, 12th ed, Merck, Whitehouse Station, NJ.
6. Chappell WR and Mordenti J (1991) Extrapolation of toxicological and pharmacological data from animals to humans, in Advances in Drug Research, vol 20 (Testa B ed) pp 1-116, Academic Press Inc., San Diego.
7. Chiba M, Nishime JA, Neway W, Lin Y, and Lin JH (2000) Comparative in vitro metabolism of indinavir in primates-a unique stereoselective hydroxylation in monkey. Xenobiotica 30: 117-129.
8. Corbett JW, Ko SS, Rodgers JD, Jeffrey S, Bacheler LT, Klabe RM, Diamond S, Lai C, Rabel SR, Saye JA, et al. (1999) Expanded-spectrum nonnucleoside reverse transcriptase inhibitors inhibit clinically relevant mutant variants of human immunodeficiency virus type 1. Antimicrob Agents Chemother 43:2893-2897.
9. Davies B and Morris T (1993) Physiological parameters in laboratory animals and humans. Pharm Res (NY) 10:1093-1095.
10. Drusano GL and Standiford HC (1985) Pharmacokinetic profile of imipenem/cilastin in normal volunteers. Am J Med 78 (Suppl 6A):47-53.
11. Evans GH, Nies AS, and Shand DG (1973) The disposition of propranolol. III. Decreased half-life and volume of distribution as a result of plasma binding in man, monkey, dog and rat. J Pharmacol Exp Ther 186:114-122.
12. Gertz J, Barrett JS, Eisenhandler R, Krupa D, Wittreich JM, Seibold JR, and Schneider SH (1993) Growth hormone response in man to L-692,429, a novel nonpeptidyl mimic of growth hormone-releasing peptide-6. J Clin Endocrinol 77:1393-1397.
13. Gibaldi M and Perrier D (1982) Pharmacokinetics, 2nd ed. Marcel Dekker Inc., New York.
14. Groll AH and Walsh TJ (2001) Caspofungin: pharmacology, safety and therapeutic potential in superficial and invasive fungal infections. Expert Opin Investig Drugs 10:1545-1558.
15. Ha HR, Chen J, Freiburghaus AU, and Follath F (1995) Metabolism of theophylline by cDNA-expressed human cytochromes P-450. Br J Clin Pharmacol 39:321-326.
16. Hajdu R, Thompson R, Sundelof JG, Pelak BA, Bouffard FA, Dropinski JF, and Kropp H (1997) Preliminary animal pharmacokinetics of the parenteral antifungal agent MK-0991 (L-743,872). Antimicrob Agents Chemother 41:2339-2344.
17. Houston BJ and Carlile DJ (1997) Prediction of hepatic clearance from microsomes, hepatocytes and liver slices. Drug Metab Rev 29:891-922.
18. Kahan FM, Kropp H, Sundelof JG, and Birnbaum J (1983) Thienamycin: development of imipenem-cilastin. J Antimicrob Chemother 12 (Suppl D):1-35.
19. Kinirons MT, O'Shea D, Kim RB, Groopman JD, Thummel KE, Wood AJJ, and Wilkinson GR (1999) Failure of erythromycin breath test to correlate with midazolam clearance as a probe of cytochrome P4503A. Clin Pharmacol Ther 66:224-231.
20. Kronbach T (1991) Bufuralol, dextromethorphan and debrisoquine as prototype substrates for human P450IID6. Methods Enzymol 206:509-517.
21. Lake BG (1987) Preparation and characterisation of microsomal fractions for studies on xenobiotic metabolism, in Biochemical Toxicology: A Practical Approach (Snell K and Mulloch B eds) pp 183-216, IRL Press, Oxford, UK.
22. Lee HS, Goh BC, Fan L, Khoo YM, Wang L, Lim R, Ong AB, and Chua C (2002) Phenotyping CYP3A using midazolam in cancer and noncancer Asian patients. Br J Clin Pharmacol 55:270-277.
23. Leung KH, Cohn DA, Miller RR, Doss GA, Stearns RA, Simpson RE, Feeney WP, and Chiu SHL (1996) Pharmacokinetics and disposition of L-692,429 A novel nonpeptide growth hormone secretagogue in preclinical species. Drug Metab Dispos 24:753-760.
24. Lewis DFV, Modi S, and Dickens M (2002) Structure-activity relationship for human cytochrome P450 substrates and inhibitors. Drug Metab Rev 34:69-82.
25. Lowry OH, Rosebrough NJ, Farr AL, and Randall RJ (1951) Protein measurement with the Folin phenol reagent. J Biol Chem 193:265-275.
26. Miners JO, Smith KJ, Robson RA, McManus ME, Veronese ME, and Birkett DJ (1988) Tolbutamide hydroxylation by human liver microsomes. Kinetic characterization and relationship to other cytochrome P450 dependent oxidations. Biochem Pharmacol 37:1137-1144.
27. Mueller WF, Coulston F, and Korte F (1982) Comparative metabolism of [14C] trichloroethylene in chimpanzees, baboons and rhesus monkeys. Chemosphere 11:215-218.
28. Mueller WF, Coulston F, and Korte F (1985) The role of the chimpanzee in the evaluation of the risk of foreign chemicals to man. Regul Toxicol Pharmacol 5:182-189.
29. Mutlib AE, Shockcor J, Chen S-Y, Espina RJ, Pinto DJ, Orwat MJ, Prakash SR, and Gan L-S (2002) Disposition of 1-[3-(aminomethyl)phenyl]-N-[3-fluoro- 2′-(methylsulfonyl)-[1,1′-biphenyl]-4-yl]-3-(trifluoromethyl) -1H-pyrazole-5-carboxamide (DPC 423) by novel metabolic pathways. Characterization by liquid chromatography/mass spectrometry and NMR. Chem Res Toxicol 15:48-62.
30. Nath BM, Schumann KE, and Boyer JD (2000) The chimpanzee and other non-human primate models in HIV-1 vaccine research. Trends Microbiol 8:426-431.
31. Newton DJ, Wang RW, and Lu AYH (1995) Cytochrome P450 inhibitors. Evaluation of specificities in the in vitro metabolism of therapeutic agents by human liver microsomes. Drug Metab Dispos 23:154-158.
32. Obach RS, Baxter JG, Liston TE, Silber BM, Jones BC, MacIntyre F, Rance DJ, and Wastall P (1997) The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data. J Pharmacol Exp Ther 283:46-58.
33. Rendic S (2002) Summary of information on human CYP enzymes: human P450 metabolism data. Drug Metab Rev 34:83-448.
34. Rodrigues AD, Kukulka MJ, Ferrero JL, and Cashman JR (1995) In vitro hepatic metabolism of ABT-418 in chimpanzee (Pan troglodytes). A unique pattern of microsomal flavin-containing monooxygenase-dependent stereoselective N′-oxidation. Drug Metab Dispos 23:1143-1152.
35. Sonderfan AJ, Arlotto MP, Dutton DR, McMillen SK, and Parkinson A (1987) Regulation of testosterone hydroxylation by rat liver cytochrome P-450. Arch Biochem Biophys 255:27-41.
36. Stone JA, Holland SD, Wickersham PJ, Sterrett A, Schartz M, Bonfiglio C, Hesney M, Winchell GA, Deutsch PJ, Greenberg H, et al. (2002) Single- and multiple-dose pharmacokinetics of caspofungin in healthy men. Antimicrob Agents Chemother 46:739-745.
37. Sundelof JG, Hajdu R, Gill CJ, Thompson R, Rosen H, and Kropp H (1997) Pharmacokinetics of L-749,345, a long-acting carbapenem antibiotic, in primates. Antimicrob Agents Chemother 41:1743-1748.
38. Sundelof JG, Thompson R, White KM, Sasor MW, Cama L, and Kropp H (1996) Pharmacokinetics in nonhuman primates of a prototype carbapenem active against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother 40:1743-1748.
39. Tjia JF, Colbert J, and Back DJ (1996) Theophylline metabolism in human liver microsomes: inhibition studies. J Pharmacol Exp Ther 276:912-917.
40. Tracy TS, Korzekwa KR, Gonzalez FJ, and Wainer IW (1999) Cytochrome P450 isoforms involved in metabolism of the enantiomers of verapamil and norverapamil. Br J Clin Pharmacol 47:545-552.
41. Uckun FM, Bellomy K, O'Neil K, Messinger Y, Johnson T, and Chen C-L (1999) Toxicity, biological activity and pharmacokinetics of TXU (anti-CD7)-pokeweed antiviral protein in chimpanzees and adult patients infected with human immunodeficiency virus. J Pharmacol Exp Ther 291:1301-1307.
42. Varma MVS, Ashokraj Y, Dey CS, and Panchagnula R (2003) P-glycoprotein inhibitors and their screening: a perspective from bioavailability enhancement. Pharmacol Res 48:347-359.
43. Von Richter O, Burk O, Fromm MF, Thon KP, Eichelbaum M, and Kivisto KT (2004) Cytochrome P450 3A4 and P-glycoprotein expression in human small intestinal enterocytes and hepatocytes: a comparative analysis in paired tissue specimens. Clin Pharmacol Ther 75:172-183.
44. Ward SA, Walle T, Walle UK, Wilkinson GR, and Branch RA (1989) Propranolol's metabolism is determined by both mephenytoin and debrisoquin hydroxylase activities. Clin Pharmacol Ther 45:72-79.
45. Wildman DE (2002) A map of the common chimpanzee genome. BioEssays 24:40-493.
46. Wilkinson GR and Shand DG (1975) A physiological approach to hepatic drug clearance. Clin Pharmacol Ther 18:377-390.
47. Wrighton SA, Stevens JC, Becker GW, and VandenBranden M (1993) Isolation and characterization of human liver cytochrome P450 2C19: correlation between 2C19 and S-mephenytoin 4′-hydroxylation. Arch Biochem Biophys 306:240-245.
48. Yoshimoto K, Echizen H, Chiba K, Tani M, and Ishizaki T (1995) Identification of human CYP isoforms involved in the metabolism of propranolol enantiomers-N-desisopropylation is mediated mainly by CYPIA2. Br J Clin Pharmacol 39:421-431.
49. Young SD, Britcher SF, Tran LO, Payne LS, Lumma WC, Lyle TA, Huff JR, Anderson PA, Olsen DB, Carroll SS, et al. (1995) L-743,726 (DMP-266): a novel highly potent nonnucleoside inhibitor of the human immunodeficiency virus type 1 reverse transcriptase. Antimicrob Agents Chemother 39:2602-2605.
50. Zacchei AG, WishouskyTI, Arison BH, and Hitzenberger G (1978) The metabolism of (2-cyclopentyl-6,7-dichloro-2-methyl-1-oxo-5 indanyloxy)acetic acid in chimpanzee and man. Drug Metab Dispos 6:303-312.