The application of target information and preclinical pharmacokinetic/ pharmacodynamic modeling in predicting clinical doses of a Dickkopf-1 antibody for osteoporosis

Journal of Pharmacology and Experimental Therapeutics

Volumn 333, Issue 1, 2010, Pages 2-13

  Betts, Alison M ^a   Clark, Tracey H ^a   Yang, Jianxin ^a   Treadway, Judith L ^a   Li, Mei ^a   Giovanelli, Michael A ^a   Abdiche, Yasmina ^a   Stone, Donna M ^a   Paralkar, Vishwas M ^a  

^a PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DICKKOPF 1 PROTEIN; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN G2; PF 04840082 PROTEIN; PROTEIN ANTIBODY; UNCLASSIFIED DRUG;

ADULT; AGED; ANIMAL EXPERIMENT; ARTICLE; BINDING AFFINITY; CALCULATION; CLINICAL STUDY; COMPLEX FORMATION; CONCENTRATION RESPONSE; CONTROLLED STUDY; DISSOCIATION CONSTANT; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG EFFICACY; FEMALE; HUMAN; IN VITRO SELECTION; INFORMATION; KINETICS; MAJOR CLINICAL STUDY; MALE; MOUSE; NONHUMAN; OSTEOPENIA; OSTEOPOROSIS; POSTMENOPAUSE; PREDICTION; PRIORITY JOURNAL; PROTEIN EXPRESSION; RAT; RECEPTOR OCCUPANCY; SINGLE DRUG DOSE; STANDARD; TURNOVER TIME;

ADULT; AGED; ANIMALS; ANTIBODIES, MONOCLONAL; BONE DISEASES, METABOLIC; FEMALE; HUMANS; INTERCELLULAR SIGNALING PEPTIDES AND PROTEINS; MACACA FASCICULARIS; MALE; MICE; MIDDLE AGED; MODELS, BIOLOGICAL; OSTEOPOROSIS; OSTEOPOROSIS, POSTMENOPAUSAL; RATS; RATS, SPRAGUE-DAWLEY;

EID: 77949739818     PISSN: 00223565     EISSN: 15210103     Source Type: Journal    
DOI: 10.1124/jpet.109.164129     Document Type: Article

References (27)

1. Agoram BM (2009) Use of pharmacokinetic/pharmacodynamic modeling for starting dose selection in first-in-human trials of high-risk biologics. Br J Clin Pharmacol 67:153-160.
2. Agoram BM, Martin SW, and van der Graaf PH (2007) The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational research of biologics. Drug Discov Today 12:1018-1024.
3. Beal SL (2001) Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn 28:481-504.
4. Boyden LM, Mao J, Belsky J, Mitzner L, Farhi A, Mitnick MA, Wu D, Insogna K, and Lifton RP (2002) High bone density due to a mutation in LDL-receptor-related protein 5. N Engl J Med 346:1513-1521.
5. Chakraborty A, Krzyzanski W, and Jusko WJ (1999) Mathematical modeling of circadian cortisol concentrations using indirect response models: comparison of several methods. J Pharmacokinet Biopharm 27:23-43.
6. Diarra D, Stolina M, Polzer K, Zwerina J, Ominsky MS, Dwyer D, Korb A, Smolen J, Hoffmann M, Scheinecker C, et al. (2007) Dickkopf-1 is a master regulator of joint remodeling. Nat Med 13:156-163.
7. Duff G (2006) Expert Scientific Group on Phase One Clinical Trials: Final Report, Department of Health, London, UK.
8. European Medicines Agency (2007) Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products, European Medicines Agency, London, UK.
9. Food and Drug Administration (2005) Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers, Food and Drug Administration, Rockville, MD.
10. Gong Y, Slee RB, Fukai N, Rawadi G, Roman-Roman S, Reginato AM, Wang H, Cundy T, Glorieux FH, Lev D, et al. (2001) LDL receptor-related protein 5 (LRP5) affects bone accrual and eye development. Cell 107:513-523.
11. Hayashi N, Tsukamoto Y, Sallas WM, and Lowe PJ (2007) A mechanism-based binding model for the population pharmacokinetics and pharmacodynamics of omalizumab. Br J Clin Pharmacol 63:548-561.
12. Hinton PR, Johlfs MG, Xiong JM, Hanestad K, Ong KC, Bullock C, Keller S, Tang MT, Tso JY, Vasquez M, et al. (2004) Engineered human IgG antibodies with longer serum half-lives in primates. J Biol Chem 279:6213-6216.
13. Holmen SL, Giambernardi TA, Zylstra CR, Buckner-Berghuis BD, Resau JH, Hess JF, Glatt V, Bouxsein ML, Ai M, Warman ML, et al. (2004) Decreased BMD and limb deformities in mice carrying mutations in both Lrp5 and Lrp6. J Bone Miner Res 19:2033-2040.
14. Institute of Laboratory Animal Research, Commission on Life Sciences, National Research Council (1996) Guide for Care and Use of Laboratory Animals, 1st ed, National Academies Press, Washington, DC.
15. Little RD, Carulli JP, Del Mastro RG, Dupuis J, Osborne M, Folz C, Manning SP, Swain PM, Zhao SC, Eustace B, et al. (2002) A mutation in the LDL receptorrelated protein 5 gene results in the autosomal dominant high-bone-mass trait. Am J Hum Genet 70:11-19.
16. Lobo ED, Hansen RJ, and Balthasar JP (2004) Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 93:2645-2668.
17. Mager DE and Jusko WJ (2001) General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn 28:507-532.
18. Marathe A, Peterson MC, and Mager DE (2008) Integrated cellular bone homeostasis model for denosumab pharmacodynamics in multiple myeloma patients. J Pharmacol Exp Ther 326:555-562.
19. Meno-Tetang GM and Lowe PJ (2005) On the prediction of the human response: a recycled mechanistic pharmacokinetic/pharmacodynamic approach. Basic Clin Pharmacol Toxicol 96:182-192.
20. Ng CM, Stefanich E, Anand BS, Fielder PJ, and Vaickus L (2006) Pharmacokinetics/pharmacodynamics of nondepleting anti-CD4 monoclonal antibody (TRX1) in healthy human volunteers. Pharmacol Res 23:95-103.
21. Paralkar VM, Stone DM, and Lei M (2009), inventors; Pfizer, USA, assignee. Antibodies specific for Dkk-1 and their uses. U.S. Patent Application PC33877. 2009 May 12.
22. Peppard JV and Orlans E (1980) The biological half-lives of four rat immunoglobulin isotypes. Immunology 40:683-686.
23. Tabrizi MA, Tseng CM, and Roskos LK (2006) Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today 11:81-88.
24. Tang L, Persky AM, Hochhaus G, and Meibohm B (2004) Pharmacokinetic aspects of biotechnology products. J Pharm Sci 93:2184-2204.
25. Tian E, Zhan F, Walker R, Rasmussen E, Ma Y, Barlogie B, and Shaughnessy JD Jr (2003) The role of the Wnt-signaling antagonist DKK1 in the development of osteolytic lesions in multiple myeloma. N Engl J Med 349:2483-2494.
26. Wang W, Wang EQ, and Balthasar JP (2008) Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 84:548-558.
27. Wu B, Joshi A, Ren S, and Ng C (2006) The application of mechanism-based PK/PD modeling in pharmacodynamic-based dose selection of muM17, a surrogate monoclonal antibody for efalizumab. J Pharm Sci 95:1258-1268.