Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis

Clinical Pharmacology and Therapeutics

Volumn 98, Issue 3, 2015, Pages 336-344

  Suri, A ^a   Chapel, S ^b   Lu, C ^a   Venkatakrishnan, K ^a  

^a MILLENNIUM PHARMACEUTICALS INC   (United States)

^b ANN ARBOR PHARMACOMETRICS GROUP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ORTERONEL; STEROID 17ALPHA MONOOXYGENASE INHIBITOR; CYTOCHROME P450 INHIBITOR; IMIDAZOLE DERIVATIVE; NAPHTHALENE DERIVATIVE; STEROID 17ALPHA MONOOXYGENASE;

ACCURACY; ADULT; ARTICLE; DRUG ELIMINATION; DRUG EXPOSURE; HUMAN; KIDNEY; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; METHODOLOGY; PHASE 3 CLINICAL TRIAL; PREDICTION; PRIORITY JOURNAL; RENAL CLEARANCE; ANTAGONISTS AND INHIBITORS; BIOLOGICAL MODEL; COMPUTER SIMULATION; DOSE CALCULATION; DRUG DEVELOPMENT; KIDNEY DISEASE; METABOLISM; NONLINEAR SYSTEM; PATHOPHYSIOLOGY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROCEDURES; REPRODUCIBILITY; URINARY EXCRETION;

CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; COMPUTER SIMULATION; CYTOCHROME P-450 ENZYME INHIBITORS; DRUG DISCOVERY; DRUG DOSAGE CALCULATIONS; HUMANS; IMIDAZOLES; KIDNEY; KIDNEY DISEASES; MODELS, BIOLOGICAL; NAPHTHALENES; NONLINEAR DYNAMICS; RENAL ELIMINATION; REPRODUCIBILITY OF RESULTS; STEROID 17-ALPHA-HYDROXYLASE;

EID: 84946409483     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.155     Document Type: Article

References (19)

1. Grillo, J.A. et al. Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice. Biopharm. Drug Dispos. 33, 99-110 (2012).
2. Li, J., Kim, S., Sha, X., Wiegand, R., Wu, J. & LoRusso, P. Complex disease-, gene-, and drug-drug interactions: impacts of renal function, CYP2D6 phenotype, and OCT2 activity on veliparib pharmacokinetics. Clin. Cancer Res. 20, 3931-3944 (2014).
3. Rowland, M., Peck, C. & Tucker, G. Physiologically-based pharmacokinetics in drug development and regulatory science. Annu. Rev. Pharmacol. Toxicol. 51, 45-73 (2011).
4. Zhao, P., Rowland, M. & Huang, S.M. Best practice in the use of physiologically based pharmacokinetic modeling and simulation to address clinical pharmacology regulatory questions. Clin. Pharmacol. Ther. 92, 17-20 (2012).
5. Jones, H.M. et al. Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective. Clin. Pharamcol. Ther. 97, 247-262 (2015).
6. Zhao, P. et al. Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. Clin. Pharmacol. Ther. 89, 259-267 (2011).
7. Lu, C., Suri, A., Shyu, W.C. & Prakash, S. Assessment of cytochrome P450-mediated drug-drug interaction potential of orteronel and exposure changes in patients with renal impairment using physiologically based pharmacokinetic modeling and simulation. Biopharm. Drug Dispos. 35, 543-552 (2014).
8. Hsu, V. et al. Towards quantitation of the effects of renal impairment and probenecid inhibition on kidney uptake and efflux transporters, using physiologically based pharmacokinetic modelling and simulations. Clin. Pharmacokinet. 53, 283-293 (2014).
9. Tortorici, M.A., Cutler, D.L., Hazra, A., Nolin, T.D., Rowland-Yeo, K. & Venkatakrishnan, K. Emerging areas of research in the assessment of pharmacokinetics in patients with chronic kidney disease. J. Clin. Pharmacol. 55, 241-250 (2015).
10. Varma, M.V., Pang, K.S., Isoherranen, N. & Zhao, P. Dealing with the complex drug-drug interactions: towards mechanistic models. Biopharm. Drug Dispos. 36, 71-92 (2015).
11. Dreicer, R. et al. Phase I/II trial of orteronel (TAK-700)-an investigational 17, 20-lyase inhibitor-in patients with metastatic castration-resistant prostate cancer. Clin. Cancer Res. 20, 1335-1344 (2014).
12. Petrylak, D. et al. Phase 1/2 study of orteronel (TAK-700), an investigational 17, 20-lyase inhibitor, with docetaxel-prednisone in metastatic castration-resistant prostate cancer. Invest. New Drugs 33, 397-408 (2015).
13. Takeda Pharmaceutical Company Limited. Press Release: Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate Cancer in Japan, U.S.A., and Europe (2014).
14. Fizazi, K. et al. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J. Clin. Oncol. 33, 723-731 (2015).
15. Saad, F. et al. Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial. Lancet Oncol. 16, 338-348 (2015).
16. Hara, T. et al. Effect of a novel 17, 20-lyase inhibitor, orteronel (TAK-700), on androgen synthesis in male rats. J. Steroid Biochem. Mol. Biol. 134, 80-91 (2013).
17. Kaku, T. et al. Discovery of orteronel (TAK-700), a naphthylmethylimidazole derivative, as a highly selective 17, 20-lyase inhibitor with potential utility in the treatment of prostate cancer. Bioorg. Med. Chem. 19, 6383-6399 (2011).
18. Rowland Yeo, K., Aarabi, M., Jamei, M. & Rostami-Hodjegan, A. Modeling and predicting drug pharmacokinetics in patients with renal impairment. Expert Rev. Clin. Pharmacol. 4, 261-274 (2011).
19. Cockcroft, D.W. & Gault, M.H. Prediction of creatinine clearance from serum creatinine. Nephron 16, 31-41 (1976).