Clinical Pharmacokinetic Studies of Enzalutamide

作者: Jacqueline A. Gibbons , Taoufik Ouatas , Walter Krauwinkel , Yoshiaki Ohtsu , Jan-Stefan van der Walt

DOI: 10.1007/S40262-015-0271-5

关键词: Prostate cancerActive metaboliteEnzalutamideOnce dailyPharmacologyHepatic impairmentPharmacokineticsPharmacology toxicologyClinical pharmacokineticMedicine

摘要: … This article describes the pharmacokinetics of enzalutamide and its active metabolite N-… pharmacokinetic determinations in the phase I dose-escalation (first-in-man) trial, enzalutamide …

参考文章(9)
Brian Davies, Tim Morris, Physiological Parameters in Laboratory Animals and Humans Pharmaceutical Research. ,vol. 10, pp. 1093- 1095 ,(1993) , 10.1023/A:1018943613122
Food-Effect Bioavailability and Fed Bioequivalence Studies Journal of Pharmaceutical Investigation. ,vol. 34, pp. 223- 228 ,(2004) , 10.4333/KPS.2004.34.3.223
Fabio Garofolo, Bioanalytical Method Validation John Wiley & Sons, Inc.. pp. 105- 138 ,(2004) , 10.1002/0471463728.CH8
Daniel Bennett, Jacqueline A Gibbons, Roelof Mol, Yoshiaki Ohtsu, Clark Williard, Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC–MS/MS Bioanalysis. ,vol. 6, pp. 737- 744 ,(2014) , 10.4155/BIO.13.325
C. Tran, S. Ouk, N. J. Clegg, Y. Chen, P. A. Watson, V. Arora, J. Wongvipat, P. M. Smith-Jones, D. Yoo, A. Kwon, T. Wasielewska, D. Welsbie, C. D. Chen, C. S. Higano, T. M. Beer, D. T. Hung, H. I. Scher, M. E. Jung, C. L. Sawyers, Development of a Second-Generation Antiandrogen for Treatment of Advanced Prostate Cancer Science. ,vol. 324, pp. 787- 790 ,(2009) , 10.1126/SCIENCE.1168175
Howard I. Scher, Karim Fizazi, Fred Saad, Mary-Ellen Taplin, Cora N. Sternberg, Kurt Miller, Ronald de Wit, Peter Mulders, Kim N. Chi, Neal D. Shore, Andrew J. Armstrong, Thomas W. Flaig, Aude Fléchon, Paul Mainwaring, Mark Fleming, John D. Hainsworth, Mohammad Hirmand, Bryan Selby, Lynn Seely, Johann S. de Bono, Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy The New England Journal of Medicine. ,vol. 367, pp. 1187- 1197 ,(2012) , 10.1056/NEJMOA1207506
John Humm, Steve Larson, Martin Fleisher, Charles L Sawyers, Howard I Scher, Tomasz M Beer, Celestia S Higano, Aseem Anand, Mary-Ellen Taplin, Eleni Efstathiou, Dana Rathkopf, Julia Shelkey, Evan Y Yu, Joshi Alumkal, David Hung, Mohammad Hirmand, Lynn Seely, Michael J Morris, Daniel C Danila, Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1-2 study. The Lancet. ,vol. 375, pp. 1437- 1446 ,(2010) , 10.1016/S0140-6736(10)60172-9
Tomasz M. Beer, Andrew J. Armstrong, Dana E. Rathkopf, Yohann Loriot, Cora N. Sternberg, Celestia S. Higano, Peter Iversen, Suman Bhattacharya, Joan Carles, Simon Chowdhury, Ian D. Davis, Johann S. de Bono, Christopher P. Evans, Karim Fizazi, Anthony M. Joshua, Choung-Soo Kim, Go Kimura, Paul Mainwaring, Harry Mansbach, Kurt Miller, Sarah B. Noonberg, Frank Perabo, De Phung, Fred Saad, Howard I. Scher, Mary-Ellen Taplin, Peter M. Venner, Bertrand Tombal, Enzalutamide in Metastatic Prostate Cancer before Chemotherapy The New England Journal of Medicine. ,vol. 371, pp. 424- 433 ,(2014) , 10.1056/NEJMOA1405095