Publication Cover
Xenobiotica
the fate of foreign compounds in biological systems
Volume 39, 2009 - Issue 7
135
Views
13
CrossRef citations to date
0
Altmetric
Research Article

Species differences in the multiple-dose pharmacokinetics of the non-nucleoside reverse transcriptase inhibitor (NNRTI) UK-453,061 in animals and man: implications for safety considerations

, , , &
Pages 534-543 | Received 22 Jan 2009, Accepted 17 Mar 2009, Published online: 29 May 2009

References

  • Allan G, Davis J, Dickins M, Gardner I, Jenkins T, Jones H, Webster R, Westgate H. 2008. Pre-clinical pharmacokinetics of UK-453,061, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and use of in silico physiologically based prediction tools to predict the oral pharmacokinetics of UK-453,061 in man. Xenobiotica 38:620–40.
  • Berruet N, Sentenac S, Auchere D, Gimenez F, Farinotti R, Fernandez C. 2005. Effect of efavirenz on intestinal p-glycoprotein and hepatic p450 function in rats. J Pharm Pharmaceut Sci 8:226–34.
  • Clarke SM, Mulcahy FM, Tjia J, Reynolds HE, Gibbons SE, Barry MG, Back DJ. 2001. The pharmacokinetics of methadone in HIV-positive patients receiving the non-nucleoside reverse transcriptase inhibitor efavirenz. Br J Clin Pharmacol 51:213–17.
  • Corbau R, Allan G, Burt C, Fishburn L, Irving S, Knoechel T, Macdonald T, Martin A, Mowbray C, Mori J, Panton W, Phillips C, Price D, Ringrose H, Selby M, Smith-Burchnell C, Stupple P, Tucker A, Webster R, Westby M, Perros M. 2007. UK-453,061: a non-nucleoside reverse transcriptase inhibitor for the treatment of drug-resistant HIV infections. Paper presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Chicago, IL, USA, 17–20 September 2007.
  • Davis J, Jenkins T, Asken E, Stafford H, Hackman F, Weissgerber G. 2007. Pharmacokinetics of single and multiple oral doses of UK-453,061, a novel NNRTI, in healthy male subjects. Paper presented at the 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Sydney, Australia, 22–25 July 2007.
  • Galteau MM, Shansa F. 2003. Urinary 6β-hydroxycortisol: a validated test for evaluating drug induction or drug inhibition mediated through CYP3A in humans and in animals. Eur J Clin Pharmacol 59:713–33.
  • Guengerich FP. 2001. Common and uncommon cytochrome P450 reactions related to metabolism and chemical toxicity. Chem Res Toxicol 14:611–50.
  • Hariparsad N, Nallard, SC, Sane RS, Buckley DJ, Buckley AR, Desai PB. 2004. Induction of CYP3A4 by efavirenz in primary human hepatocytes: comparison with rifampin and phenobarbital. J Clin Pharmacol 44:1273–81.
  • Hayashi S, Jayesekera D, Jayewardene A, Shah A, Thevanayagam L, Aweeka F. 1999. Altered pharmacokinetics of indinavir by a novel non-nucleoside reverse transcriptase inhibitor (HBY-097): a pharmacokinetic evaluation in HIV-positive patients. J Clin Pharmacol 39:1085–93.
  • Hewitt NJ, Lecluyse EL, Ferguson SS. 2007. Induction of hepatic cytochrome P450 enzymes: methods, mechanisms, recommendations, and in vitro–in vivo correlations. Xenobiotica 37:1196–224.
  • Ji P, Damle B, Xie J, Unger SE, Grasela DM, Kaul S. 2008. Pharmacokinetic interaction between efavirenz and carbamazepine after multiple-dose administration in healthy subjects. J Clin Pharmacol 48:948–56.
  • Martins S, Ramos MJ, Fernandes PA. 2008. The current status of the NNRTI family of antiretrovirals used in the HAART regime against HIV infection. Curr Med Chem 15:1083–95.
  • Mitchell P. 2007. Critics pan timid European response to TeGenero disaster. Nat Biotech 25:485–6.
  • Monro A. 1994. Drug toxicokinetics: scope and limitations that arise from species differences in pharmacodynamic and carcinogenic response. J Pharmacokinet Biopharmaceut 22:41–57.
  • Ohno M, Yamaguchi I, Saiki K, Yamamoto I, Azuma J. 2000. Specific determination of urinary 6β-hydroxycortisol and cortisol by liquid chromatography-atmospheric pressure chemical ionization mass spectrometry. J Chromatograph B Biomed Sci Appl 746:95–101.
  • Parkinson A, Ogilvie BW. 2008. Biotransformation of xenobiotics. In: Klaassen CD ed. Casarett and Doull’s toxicology: the basic science of poisons, 7th ed. New York, NY: McGraw-Hill. p. 161–304.
  • Richens A, Woodford FP. 1976. Liver enzyme induction by antiepileptic drugs: its clinical significance. In: Richens A, Woodford FP. eds. Anticonvulsant drugs and enzyme induction. Amsterdam: Elsevier. p. 3–12.
  • Shah VP, Midha KK, Findlay JWA, Hill HM, Hulse JD, McGilveray IJ, McKay G, Miller KJ, Patnaik RN, Powell ML, Tonelli A, Viswanathan CT, Yacobi A. 2000. Bioanalytical method validation — a revisit with a decade of progress. Pharmaceut Res 17:1551–7.
  • Singh G, Driever PH, Sander JW. 2005. Cancer risk in people with epilepsy: the role of antiepileptic drugs. Brain 128:7–17.
  • Smith DA, Beaumont K. Cussans NJ, Humphrey MJ, Jezequel SG, Rance DJ, Stopher DA, Walker DK. 1992. Bioanalytical data in decision making: discovery and development. Xenobiotica 22:1195–205.
  • Smith DA, Humphrey MJ, Charuel C. 1990. Design of toxicokinetic studies. Xenobiotica 20:1187–99.
  • Stevens JL. 2006. Future of toxicology — mechanisms of toxicity and drug safety: where do we go from here? Chem Res Toxicol 19:1393–401.
  • Von Moltke LL, Greenblatt DJ, Granda BW, Giancarlo GM, Duan SX, Daily JP, Harmatz JS, Shader RI. 2001. Inhibition of human cytochrome P450 isoforms by nonnucleoside reverse transcriptase inhibitors. J Clin Pharmacol 41:85–91.
  • Walker DK. 2004. The use of pharmacokinetic and pharmacodynamic data in the assessment of drug safety in early drug development. Br J Clin Pharmacol 58:601–8.
  • Webster R, Leishman D, Walker D. 2002. Towards a drug concentration effect relationship for QT prolongation and torsades de pointes. Curr Opin Drug Disc Dev 5:116–26.
  • Zhou C, Assem M, Tay JC, Watkins PB, Blumberg B, Schuetz EG, Thummel KE. 2006. Steroid and xenobiotic receptor and vitamin D receptor crosstalk mediates CYP24 expression and drug-induced osteomalacia. J Clin Invest 116:1703–12.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.