Maraviroc: In vitro assessment of drug-drug interaction potential

British Journal of Clinical Pharmacology

Volumn 66, Issue 4, 2008, Pages 498-507

  Hyland, Ruth ^a   Dickins, Maurice ^a   Collins, Claire ^a   Jones, Hannah ^a   Jones, Barry ^a  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Drug drug interactions; In vitro metabolism; Maraviroc; Simcyp

Indexed keywords

AMFEBUTAMONE; ATAZANAVIR; CYTOCHROME; CYTOCHROME P450; CYTOCHROME P450 3A4; DEXTROMETHORPHAN; DICLOFENAC; DRUG METABOLITE; FELODIPINE; KETOCONAZOLE; MARAVIROC; MEPHENYTOIN; MIDAZOLAM; PHENACETIN; RITONAVIR; ROSIGLITAZONE; SAQUINAVIR; SIMCYP; TESTOSTERONE; UK 408027; UNCLASSIFIED DRUG;

AEROBIC METABOLISM; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DEALKYLATION; DRUG ABSORPTION; DRUG BINDING; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFECT; DRUG ELIMINATION; DRUG METABOLISM; ENZYME INHIBITION; ENZYME KINETICS; ENZYME SUBSTRATE; HUMAN; IN VITRO STUDY; MALE; PRIORITY JOURNAL; SIMULATION;

AREA UNDER CURVE; CYCLOHEXANES; CYTOCHROME P-450 CYP3A; DRUG INTERACTIONS; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; KETOCONAZOLE; LIVER; MALE; MICROSOMES, LIVER; OLIGOPEPTIDES; PREDICTIVE VALUE OF TESTS; PYRIDINES; RITONAVIR; SAQUINAVIR; TRIAZOLES;

EID: 51649088021     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2008.03198.x     Document Type: Article

References (33)

1. Dorr P, Westby M, Dobbs S, Griffin P, Irvine B, Macartney M, Mori J, Rickett G, Smith-Burchnell C, Napier C, Webster R, Armour D, Price D, Stammen B, Wood A, Perros M. Maraviroc (UK-427,857), a potent, orally bioavailable, and selective small-molecule inhibitor of chemokine receptor ccr5 with broad-spectrum anti-human immunodeficiency virus type 1 activity. Antimicrob Agents Chemother 2005 49: 4721 32.
2. Walker DK, Abel S, Comby P, Muirhead GJ, Nedderman AN, Smith DA. Species differences in the disposition of the CCR5 antagonist, UK-427,857, a new potential treatment for HIV. Drug Metab Dispos 2005 33: 587 95.
3. Fatkenheuer G, Pozniak AL, Johnson MA, Plettenberg A, Staszewski S, Hoepelman AI, Saag MS, Goebel FD, Rockstroh JK, Dezube BJ, Jenkins TM, Medhurst C, Sullivan JF, Ridgway C, Abel S, James IT, Youle M, van der Ryst E. Efficacy of short-term monotherapy with maraviroc, a new CCR5 antagonist, in patients infected with HIV-1. Nat Med 2005 11: 1170 2.
4. Yeni PG, Hammer SM, Hirsch MS, Saag MS, Schechter M, Carpenter CC, Fischl MA, Gatell JM, Gazzard BG, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Schooley RT, Thompson MA, Vella S, Volberding PA. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA 2004 292: 251 65.
5. Tseng AL, Foisy MM. Management of drug interactions in patients with HIV. Ann Pharmacother 1997 31: 1040 58.
6. Abel S, Russell D, Whitlock LA, Ridgeway CE, Nedderman ANR, Walker DK. Assessment of the absorption, metabolism, and absolute bioavailability of maraviroc in healthy male subjects. Br J Clin Pharmacol 2008 65 (Suppl. 1 60 7.
7. Hyland R, Roe EG, Jones BC, Smith DA. Identification of the cytochrome P450 enzymes involved in the N-demethylation of sildenafil. Br J Clin Pharmacol 2001 51: 239 48.
8. Walsky RL, Obach RS. Validated assays for human cytochrome P450 activities. Drug Metab Dispos 2004 32: 647 60.
9. Walsky RL, Obach RS, Gaman EA, Gleeson JP, Proctor WR. Selective inhibition of human cytochrome P4502C8 by montelukast. Drug Metab Dispos 2005 33: 413 8.
10. Abel S, Russell D, Taylor-Worth RJ, Ridgeway CE, Muirhead GJ. Effects of CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol 2008 65 (Suppl. 1 27 37.
11. Goldsmith DR, Perry CM. Atazanavir. Drugs 2003 63: 1679 93 discussion 1694 5.
12. Bristol-Myers Squibb C. Reyataz NDA 021567; FDA Approved Drug Products. Available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (last accessed: 22 April 2008).
13. Proctor NJ, Tucker GT, Rostami-Hodjegan A. Predicting drug clearance from recombinantly expressed CYPs: intersystem extrapolation factors. Xenobiotica 2004 34: 151 78.
14. Ernest CS II., Hall SD, Jones DR. Mechanism-based inactivation of CYP3A by HIV protease inhibitors. J Pharmacol Exp Ther 2005 312: 583 91.
15. Mayhew BS, Jones DR, Hall SD. An in vitro model for predicting in vivo inhibition of cytochrome P450 3A4 by metabolic intermediate complex formation. Drug Metab Dispos 2000 28: 1031 7.
16. Obach RS, Walsky RL, Venkatakrishnan K. Mechanism-based inactivation of human cytochrome p450 enzymes and the prediction of drug-drug interactions. Drug Metab Dispos 2007 35: 246 55.
17. Poulin P, Theil FP. A priori prediction of tissue: plasma partition coefficients of drugs to facilitate the use of physiologically-based pharmacokinetic models in drug discovery. J Pharm Sci 2000 89: 16 35.
18. Austin RP, Barton P, Cockroft SL, Wenlock MC, Riley RJ. The influence of nonspecific microsomal binding on apparent intrinsic clearance, and its prediction from physicochemical properties. Drug Metab Dispos 2002 30: 1497 503.
19. Rostami-Hodjegan A, Tucker GT. Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat Rev Drug Discov 2007 6: 140 8.
20. Rendic S. Summary of information on human CYP enzymes: human P450 metabolism data. Drug Metab Rev 2002 34: 83 448.
21. Pfizer Inc. Selzentry NDA 022128; FDA Approved Drug Products. Available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm (last accessed: 22 April 2008).
22. Abel S, Russell D, Whitlock LA, Ridgeway CE, Muirhead GJ. Effects of maraviroc on the pharmacokinetics of midazolam, lamivudine/zidovudine, and oral contraceptives in healthy volunteers. Br J Clin Pharmacol 2008 65 (Suppl. 1 19 26.
23. Rowland-Yeo K, Jamei M, Yang J, Tucker GT, Rostami-Hodjegan A. Prediction of in vivo drug interactions from in vitro enzyme kinetic data: time based versus steady state simulations. 2007. Available at http://www.simcyp.com/ ResearchDevelopment/Publications/Posters/default.htm (last accessed: 22 April 2008).
24. Hsu A, Granneman GR, Witt G, Locke C, Denissen J, Molla A, Valdes J, Smith J, Erdman K, Lyons N, Niu P, Decourt JP, Fourtillan JB, Girault J, Leonard JM. Multiple-dose pharmacokinetics of ritonavir in human immunodeficiency virus-infected subjects. Antimicrob Agents Chemother 1997 41: 898 905.
25. Palkama VJ, Ahonen J, Neuvonen PJ, Olkkola KT. Effect of saquinavir on the pharmacokinetics and pharmacodynamics of oral and intravenous midazolam. Clin Pharmacol Ther 1999 66: 33 9.
26. Einolf HJ. Comparison of different approaches to predict metabolic drug-drug interactions. Xenobiotica 2007 37: 1257 94.
27. Fellay J, Marzolini C, Decosterd L, Golay KP, Baumann P, Buclin T, Telenti A, Eap CB. Variations of CYP3A activity induced by antiretroviral treatment in HIV-1 infected patients. Eur J Clin Pharmacol 2005 60: 865 73.
28. Almond L, Rowland Yeo K, Howgate E, Tucker GT, Rostami-Hodjegan A. Mechanistic prediction of HIV drug-drug interactions in virtual populations from in vitro enzyme kinetic data: ritonavir and saquinavir. 2007. Available at http://www.simcyp.com/ResearchDevelopment/Publications/Posters/default.htm (last accessed: 22 April 2008).
29. Buss N, Snell P, Bock J, Hsu A, Jorga K. Saquinavir and ritonavir pharmacokinetics following combined ritonavir and saquinavir (soft gelatin capsules) administration. Br J Clin Pharmacol 2001 52: 255 64.
30. Chinn LW, Gow JM, Tse MM, Becker SL, Kroetz DL. Interindividual variability in the effect of atazanavir and saquinavir on the expression of lymphocyte P-glycoprotein. J Antimicrob Chemother 2007 60: 61 7.
31. Huisman MT, Smit JW, Wiltshire HR, Hoetelmans RM, Beijnen JH, Schinkel AH. P-glycoprotein limits oral availability, brain, and fetal penetration of saquinavir even with high doses of ritonavir. Mol Pharmacol 2001 59: 806 13.
32. Rautio J, Humphreys JE, Webster LO, Balakrishnan A, Keogh JP, Kunta JR, Serabjit-Singh CJ, Polli JW. In vitro p-glycoprotein inhibition assays for assessment of clinical drug interaction potential of new drug candidates: a recommendation for probe substrates. Drug Metab Dispos 2006 34: 786 92.
33. Smalley J, Marino AM, Xin B, Olah T, Balimane PV. Development of a quantitative LC-MS/MS analytical method coupled with turbulent flow chromatography for digoxin for the in vitro P-gp inhibition assay. J Chromatogr B Analyt Technol Biomed Life Sci 2007 854: 260 7.