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Volumn 13, Issue 4, 2011, Pages 565-575

Quantitative PK-PD model-based translational pharmacology of a novel kappa opioid receptor antagonist between rats and humans

Author keywords

kappa opioid receptor antagonist; PK PD modeling; proof of mechanism; translational pharmacology

Indexed keywords

2 METHYL N [[2' (PYRROLIDIN 1 YLSULFONYL)BIPHENYL 4 YL]METHYL]PROPAN 1 AMINE; KAPPA OPIATE RECEPTOR ANTAGONIST; PF 04455242; PLACEBO; PROLACTIN; SPIRADOLINE; UNCLASSIFIED DRUG;

EID: 83555166044     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-011-9296-3     Document Type: Article
Times cited : (38)

References (33)
  • 1
    • 0006279789 scopus 로고
    • Species, strain and sex differences in metabolism of hexobarbitone, amidopyrine, antipyrine and aniline
    • 10.1016/0006-2952(58)90024-8
    • GP Quinn J Axelrod BB Brodie 1958 Species, strain and sex differences in metabolism of hexobarbitone, amidopyrine, antipyrine and aniline Biochem Pharmacol 1 152 9 10.1016/0006-2952(58)90024-8
    • (1958) Biochem Pharmacol , vol.1 , pp. 152-9
    • Quinn, G.P.1    Axelrod, J.2    Brodie, B.B.3
  • 2
    • 0019974098 scopus 로고
    • Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics
    • DOI 10.1007/BF01062336
    • H Boxenbaum 1982 Interspecies scaling, allometry, physiological time, and the ground plan of pharmacokinetics J Pharmacokinet Biopharm 10 2 201 27 7120049 10.1007/BF01062336 1:CAS:528:DyaL38Xlt1Sjtbo%3D (Pubitemid 12044187)
    • (1982) Journal of Pharmacokinetics and Biopharmaceutics , vol.10 , Issue.2 , pp. 201-227
    • Boxenbaum, H.1
  • 3
    • 0017335453 scopus 로고
    • Prediction of hepatic extraction ratio from in vitro measurement of intrinsic clearance
    • A Rane GR Wilkinson DG Shand 1977 Prediction of hepatic extraction ratio from in vitro measurement of intrinsic clearance J Pharmacol Exp Ther 200 2 420 4 839445 1:CAS:528:DyaE2sXhtFCru70%3D (Pubitemid 8037500)
    • (1977) Journal of Pharmacology and Experimental Therapeutics , vol.200 , Issue.2 , pp. 420-424
    • Rane, A.1    Wilkinson, G.R.2    Shand, D.G.3
  • 4
    • 34447330544 scopus 로고    scopus 로고
    • Whole-body physiologically based pharmacokinetic models
    • DOI 10.1517/17425255.3.2.235
    • I Nestorov 2007 Whole-body physiologically based pharmacokinetic models Expert Opin Drug Metab Toxicol. 3 2 235 49 17428153 10.1517/17425255.3.2.235 1:CAS:528:DC%2BD2sXktFansLg%3D (Pubitemid 47321518)
    • (2007) Expert Opinion on Drug Metabolism and Toxicology , vol.3 , Issue.2 , pp. 235-249
    • Nestorov, I.1
  • 5
    • 65449166750 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetics from preclinical information: Comparative accuracy of quantitative prediction approaches
    • 19299532 10.1177/0091270009333209 1:CAS:528:DC%2BD1MXlsFWmu74%3D
    • NA Hosea WT Collard S Cole TS Maurer RX Fang H Jones, et al. 2009 Prediction of human pharmacokinetics from preclinical information: comparative accuracy of quantitative prediction approaches J Clin Pharmacol 49 5 513 33 19299532 10.1177/0091270009333209 1:CAS:528:DC%2BD1MXlsFWmu74%3D
    • (2009) J Clin Pharmacol , vol.49 , Issue.5 , pp. 513-33
    • Hosea, N.A.1    Collard, W.T.2    Cole, S.3    Maurer, T.S.4    Fang, R.X.5    Jones, H.6
  • 6
    • 43949084744 scopus 로고    scopus 로고
    • Development of translational pharmacokinetic-pharmacodynamic models
    • DOI 10.1038/clpt.2008.52, PII CLPT200852
    • DE Mager WJ Jusko 2008 Development of translational pharmacokinetic- pharmacodynamic models Clin Pharmacol Ther 83 6 909 12 18388873 10.1038/clpt.2008.52 1:CAS:528:DC%2BD1cXlvFOrtb0%3D (Pubitemid 351704927)
    • (2008) Clinical Pharmacology and Therapeutics , vol.83 , Issue.6 , pp. 909-912
    • Mager, D.E.1    Jusko, W.J.2
  • 7
    • 67649312041 scopus 로고    scopus 로고
    • Scaling pharmacodynamics from in vitro and preclinical animal studies to humans
    • 19252333 10.2133/dmpk.24.16 1:CAS:528:DC%2BD1MXks1Whu78%3D
    • DE Mager S Woo WJ Jusko 2009 Scaling pharmacodynamics from in vitro and preclinical animal studies to humans Drug Metab Pharmacokinet. 24 1 16 24 19252333 10.2133/dmpk.24.16 1:CAS:528:DC%2BD1MXks1Whu78%3D
    • (2009) Drug Metab Pharmacokinet. , vol.24 , Issue.1 , pp. 16-24
    • Mager, D.E.1    Woo, S.2    Jusko, W.J.3
  • 8
    • 4344689671 scopus 로고    scopus 로고
    • Modeling and allometric scaling of s(+)-ketoprofen pharmacokinetics and pharmacodynamics: A retrospective analysis
    • DOI 10.1111/j.1365-2885.2004.00579.x
    • EI Lepist WJ Jusko 2004 Modeling and allometric scaling of s(+)-ketoprofen pharmacokinetics and pharmacodynamics: a retrospective analysis J Vet Pharmacol Ther 27 4 211 8 15305849 10.1111/j.1365-2885.2004.00579.x 1:CAS:528:DC%2BD2cXotVCgtrY%3D (Pubitemid 39141606)
    • (2004) Journal of Veterinary Pharmacology and Therapeutics , vol.27 , Issue.4 , pp. 211-218
    • Lepist, E.-I.1    Jusko, W.J.2
  • 9
    • 34548077901 scopus 로고    scopus 로고
    • Interspecies comparisons of pharmacokinetics and pharmacodynamics of recombinant human erythropoietin
    • DOI 10.1124/dmd.107.015248
    • S Woo WJ Jusko 2007 Interspecies comparisons of pharmacokinetics and pharmacodynamics of recombinant human erythropoietin Drug Metab Dispos 35 9 1672 8 17576810 10.1124/dmd.107.015248 1:CAS:528:DC%2BD2sXpslKqsL8%3D (Pubitemid 47296063)
    • (2007) Drug Metabolism and Disposition , vol.35 , Issue.9 , pp. 1672-1678
    • Woo, S.1    Jusko, W.J.2
  • 10
    • 34848838605 scopus 로고    scopus 로고
    • 1A receptor mediated responses from rat to man
    • DOI 10.1007/s11095-007-9336-y
    • KP Zuideveld PH Van der Graaf LA Peletier M Danhof 2007 Allometric scaling of pharmacodynamic responses: application to 5-Ht1A receptor mediated responses from rat to man Pharm Res 24 11 2031 9 17541734 10.1007/s11095-007- 9336-y 1:CAS:528:DC%2BD2sXhtV2msbrO (Pubitemid 47493572)
    • (2007) Pharmaceutical Research , vol.24 , Issue.11 , pp. 2031-2039
    • Zuideveld, K.P.1    Van Der Graaf, P.H.2    Peletier, L.A.3    Danhof, M.4
  • 11
    • 34347218910 scopus 로고    scopus 로고
    • Clinical attrition due to biased preclinical assessments of potential efficacy
    • DOI 10.1016/j.pharmthera.2007.05.002, PII S0163725807000861
    • MD Lindner 2007 Clinical attrition due to biased preclinical assessments of potential efficacy Pharmacol Ther 115 1 148 75 17574680 10.1016/j.pharmthera. 2007.05.002 1:CAS:528:DC%2BD2sXntFyitbk%3D (Pubitemid 46992811)
    • (2007) Pharmacology and Therapeutics , vol.115 , Issue.1 , pp. 148-175
    • Lindner, M.D.1
  • 12
    • 24944547571 scopus 로고    scopus 로고
    • Why drugs fail - A study on side effects in new chemical entities
    • DOI 10.2174/138161205774414510
    • D Schuster C Laggner T Langer 2005 Why drugs fail-a study on side effects in new chemical entities Curr Pharm Des 11 27 3545 59 16248807 10.2174/138161205774414510 1:CAS:528:DC%2BD2MXhtVWrs7rE (Pubitemid 41300759)
    • (2005) Current Pharmaceutical Design , vol.11 , Issue.27 , pp. 3545-3559
    • Schuster, D.1    Laggner, C.2    Langer, T.3
  • 13
    • 41349119550 scopus 로고    scopus 로고
    • Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research
    • 18353445 10.1016/j.tips.2008.01.007 1:CAS:528:DC%2BD1cXksVehsrw%3D
    • M Danhof EC de Lange OE Della Pasqua BA Ploeger RA Voskuyl 2008 Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research Trends Pharmacol Sci 29 4 186 91 18353445 10.1016/j.tips.2008.01.007 1:CAS:528:DC%2BD1cXksVehsrw%3D
    • (2008) Trends Pharmacol Sci , vol.29 , Issue.4 , pp. 186-91
    • Danhof, M.1    De Lange, E.C.2    Della Pasqua, O.E.3    Ploeger, B.A.4    Voskuyl, R.A.5
  • 14
    • 80054793356 scopus 로고    scopus 로고
    • Pharmacological characterization of 2-methyl-N-((2'-(pyrrolidin-1- ylsulfonyl)biphenyl-4-yl)methyl)propan-1-amine (PF-04455242), a high-affinity antagonist selective for kappa opioid receptors
    • doi: 10.1124/jpet.111.185108
    • Grimwood S, Lu Y, Schmidt AW, Vanase-Frawley MA, Sawant-Basak A, Miller E, McLean S, Freeman J, Wong S, McLaughlin JP, Verhoest PR. Pharmacological characterization of 2-methyl-N-((2'-(pyrrolidin-1-ylsulfonyl)biphenyl-4-yl) methyl)propan-1-amine (PF-04455242), a high-affinity antagonist selective for kappa opioid receptors. J Pharmacol Exp Ther. 2011. doi: 10.1124/jpet.111. 185108.
    • (2011) J Pharmacol Exp Ther
    • Grimwood, S.1    Lu, Y.2    Schmidt, A.W.3    Vanase-Frawley, M.A.4    Sawant-Basak, A.5    Miller, E.6    McLean, S.7    Freeman, J.8    Wong, S.9    McLaughlin, J.P.10    Verhoest, P.R.11
  • 15
    • 0023836656 scopus 로고
    • Opposite effects of mu and kappa opiate agonists on dopamine release in the nucleus accumbens and in the dorsal caudate of freely moving rats
    • G Di Chiara A Imperato 1988 Opposite effects of mu and kappa opiate agonists on dopamine release in the nucleus accumbens and in the dorsal caudate of freely moving rats J Pharmacol Exp Ther 244 3 1067 80 2855239 (Pubitemid 18090131)
    • (1988) Journal of Pharmacology and Experimental Therapeutics , vol.244 , Issue.3 , pp. 1067-1080
    • Di Chiara, G.1    Imperato, A.2
  • 16
    • 0033988331 scopus 로고    scopus 로고
    • Effects of E-2078, a stable dynorphin A(1-8) analog, on sedation and serum prolactin levels in rhesus monkeys
    • DOI 10.1007/s002130051144
    • ER Butelman TJ Harris MJ Kreek 1999 Effects of E-2078, a stable dynorphin A(1-8) analog, on sedation and serum prolactin levels in rhesus monkeys Psychopharmacology (Berl) 147 1 73 80 10.1007/s002130051144 1:CAS:528: DC%2BD3cXpslOjuw%3D%3D (Pubitemid 30010026)
    • (1999) Psychopharmacology , vol.147 , Issue.1 , pp. 73-80
    • Butelman, E.R.1    Harris, T.J.2    Kreek, M.-J.3
  • 17
    • 0027215839 scopus 로고
    • Neuroendocrine and behavioral effects of the selective kappa agonist spiradoline in Tourette's syndrome: A pilot study
    • DOI 10.1016/0165-1781(93)90084-T
    • PB Chappell JF Leckman LD Scahill MT Hardin G Anderson DJ Cohen 1993 Neuroendocrine and behavioral effects of the selective kappa agonist spiradoline in Tourette's syndrome: a pilot study Psychiatry Res 47 3 267 80 8396784 10.1016/0165-1781(93)90084-T 1:CAS:528:DyaK2cXhvVyksbk%3D (Pubitemid 23190385)
    • (1993) Psychiatry Research , vol.47 , Issue.3 , pp. 267-280
    • Chappell, P.B.1    Leckman, J.F.2    Scahill, L.D.3    Hardin, M.T.4    Anderson, G.5    Cohen, D.J.6
  • 18
    • 0030972607 scopus 로고    scopus 로고
    • The effects of spiradoline (U-62066E), a κ-opioid receptor agonist, on neuroendocrine function in man
    • DOI 10.1038/sj.bjp.0700971
    • E Ur DM Wright PM Bouloux A Grossman 1997 The effects of spiradoline (U-62066E), a kappa-opioid receptor agonist, on neuroendocrine function in man Br J Pharmacol 120 5 781 4 9138682 10.1038/sj.bjp.0700971 1:CAS:528: DyaK2sXhvFSjtLc%3D (Pubitemid 27122716)
    • (1997) British Journal of Pharmacology , vol.120 , Issue.5 , pp. 781-784
    • Ur, E.1    Wright, D.M.2    Bouloux, P.M.G.3    Grossman, A.4
  • 19
    • 0024811135 scopus 로고
    • Neuroendrocrine regulation of prolactin release
    • DOI 10.1016/0301-0082(89)90008-7
    • N Ben-Jonathan LA Arbogast JF Hyde 1989 Neuroendocrine [corrected] regulation of prolactin release Prog Neurobiol 33 5-6 399 447 2695976 10.1016/0301-0082(89)90008-7 1:CAS:528:DyaK3cXhtlanu7k%3D (Pubitemid 20032992)
    • (1989) Progress in Neurobiology , vol.33 , Issue.5-6 , pp. 399-447
    • Ben-Jonathan, N.1    Arbogast, L.A.2    Hyde, J.F.3
  • 21
    • 34047114789 scopus 로고    scopus 로고
    • Use of plasma and brain unbound fractions to assess the extent of brain distribution of 34 drugs: Comparison of unbound concentration ratios to in vivo P-glycoprotein efflux ratios
    • DOI 10.1124/dmd.106.012294
    • JC Kalvass TS Maurer GM Pollack 2007 Use of plasma and brain unbound fractions to assess the extent of brain distribution of 34 drugs: comparison of unbound concentration ratios to in vivo p-glycoprotein efflux ratios Drug Metab Dispos. 35 4 660 6 17237155 10.1124/dmd.106.012294 1:CAS:528: DC%2BD2sXktVOntb4%3D (Pubitemid 46513270)
    • (2007) Drug Metabolism and Disposition , vol.35 , Issue.4 , pp. 660-666
    • Kalvass, J.C.1    Maurer, T.S.2    Pollack, G.M.3
  • 22
    • 34249012493 scopus 로고    scopus 로고
    • Population pharmacokinetic/pharmacodynamic modeling of systemic corticosteroid inhibition of whole blood lymphocytes: Modeling interoccasion pharmacodynamic variability
    • DOI 10.1007/s11095-006-9232-x
    • Y Hong DE Mager RA Blum WJ Jusko 2007 Population pharmacokinetic/ pharmacodynamic modeling of systemic corticosteroid inhibition of whole blood lymphocytes: modeling interoccasion pharmacodynamic variability Pharm Res 24 6 1088 97 17385022 10.1007/s11095-006-9232-x 1:CAS:528:DC%2BD2sXlsVGns7w%3D (Pubitemid 46798887)
    • (2007) Pharmaceutical Research , vol.24 , Issue.6 , pp. 1088-1097
    • Hong, Y.1    Mager, D.E.2    Blum, R.A.3    Jusko, W.J.4
  • 24
    • 0142040189 scopus 로고    scopus 로고
    • Dose Equivalency Evaluation of Major Corticosteroids: Pharmacokinetics and Cell Trafficking and Cortisol Dynamics
    • DOI 10.1177/0091270003258651
    • DE Mager SX Lin RA Blum CD Lates WJ Jusko 2003 Dose equivalency evaluation of major corticosteroids: pharmacokinetics and cell trafficking and cortisol dynamics J Clin Pharmacol 43 11 1216 27 14551176 10.1177/ 0091270003258651 1:CAS:528:DC%2BD3sXptFKitbk%3D (Pubitemid 37280793)
    • (2003) Journal of Clinical Pharmacology , vol.43 , Issue.11 , pp. 1216-1227
    • Mager, D.E.1    Lin, S.X.2    Blum, R.A.3    Lates, C.D.4    Jusko, W.J.5
  • 25
    • 0029876997 scopus 로고    scopus 로고
    • Comparative pharmacodynamics of eight calcium channel blocking agents in Japanese essential hypertensive patients
    • S Shimada Y Nakajima K Yamamoto Y Sawada T Iga 1996 Comparative pharmacodynamics of eight calcium channel blocking agents in Japanese essential hypertensive patients Biol Pharm Bull 19 3 430 7 8924914 10.1248/bpb.19.430 1:CAS:528:DyaK28XhvV2qtL4%3D (Pubitemid 26098577)
    • (1996) Biological and Pharmaceutical Bulletin , vol.19 , Issue.3 , pp. 430-437
    • Shimada, S.1    Nakajima, Y.2    Yamamoto, K.3    Sawada, Y.4    Iga, T.5
  • 26
    • 0003747347 scopus 로고
    • NONMEM Project Group, University of California San Francisco
    • Beal SL, Sheiner LB. NONMEM user's guides. San Francisco: NONMEM Project Group, University of California; 1992.
    • (1992) NONMEM User's Guides
    • Beal, S.L.1    Sheiner, L.B.2
  • 28
    • 0034764915 scopus 로고    scopus 로고
    • Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check
    • DOI 10.1023/A:1011555016423
    • Y Yano SL Beal LB Sheiner 2001 Evaluating pharmacokinetic/pharmacodynamic models using the posterior predictive check J Pharmacokinet Pharmacodyn 28 2 171 92 11381569 10.1023/A:1011555016423 1:STN:280:DC%2BD38%2FhtV2htg%3D%3D (Pubitemid 33030044)
    • (2001) Journal of Pharmacokinetics and Pharmacodynamics , vol.28 , Issue.2 , pp. 171-192
    • Yano, Y.1    Beal, S.L.2    Sheiner, L.B.3
  • 29
    • 0015158392 scopus 로고
    • Metabolic clearance and secretion rates of prolactin in the rat
    • 5107044 10.1210/endo-89-5-1303 1:CAS:528:DyaE38Xitleqsg%3D%3D
    • Y Koch YF Chow J Meites 1971 Metabolic clearance and secretion rates of prolactin in the rat Endocrinology 89 5 1303 8 5107044 10.1210/endo-89-5-1303 1:CAS:528:DyaE38Xitleqsg%3D%3D
    • (1971) Endocrinology , vol.89 , Issue.5 , pp. 1303-8
    • Koch, Y.1    Chow, Y.F.2    Meites, J.3
  • 30
    • 0023244131 scopus 로고
    • Pharmacokinetic studies of highly purified human prolactin in normal human subjects
    • ME Molitch S Raiti G Baumann S Belknap S Reichlin 1987 Pharmacokinetic studies of highly purified human prolactin in normal human subjects J Clin Endocrinol Metab 65 2 299 304 3597709 10.1210/jcem-65-2-299 1:CAS:528: DyaL2sXkvFSntro%3D (Pubitemid 17103014)
    • (1987) Journal of Clinical Endocrinology and Metabolism , vol.65 , Issue.2 , pp. 299-304
    • Molitch, M.E.1    Raiti, S.2    Baumann, G.3
  • 31
    • 0022969408 scopus 로고
    • Effects of a kappa-opioid agonist on adrenocorticotropic and diuretic function in man
    • A Pfeiffer W Knepel S Braun HD Meyer H Lohmann V Brantl 1986 Effects of a kappa-opioid agonist on adrenocorticotropic and diuretic function in man Horm Metab Res 18 12 842 8 3028922 10.1055/s-2007-1012453 1:CAS:528: DyaL2sXhvVyrsb4%3D (Pubitemid 17196588)
    • (1986) Hormone and Metabolic Research , vol.18 , Issue.12 , pp. 842-848
    • Pfeiffer, A.1    Knepel, W.2    Braun, S.3
  • 32
    • 0026075799 scopus 로고
    • Mechanism of diuretic action of spiradoline (U-62066E)-a kappa opioid receptor agonist in the human
    • 1659438 1:CAS:528:DyaK38XhsFKjtw%3D%3D
    • GH Rimoy NK Bhaskar DM Wright PC Rubin 1991 Mechanism of diuretic action of spiradoline (U-62066E)-a kappa opioid receptor agonist in the human Br J Clin Pharmacol 32 5 611 5 1659438 1:CAS:528:DyaK38XhsFKjtw%3D%3D
    • (1991) Br J Clin Pharmacol , vol.32 , Issue.5 , pp. 611-5
    • Rimoy, G.H.1    Bhaskar, N.K.2    Wright, D.M.3    Rubin, P.C.4
  • 33
    • 0036144662 scopus 로고    scopus 로고
    • Pharmacokinetic/pharmacodynamic studies in drug product development
    • DOI 10.1002/jps.1167
    • B Meibohm H Derendorf 2002 Pharmacokinetic/pharmacodynamic studies in drug product development J Pharm Sci 91 1 18 31 11782894 10.1002/jps.1167 1:CAS:528:DC%2BD38Xmslyitg%3D%3D (Pubitemid 34074464)
    • (2002) Journal of Pharmaceutical Sciences , vol.91 , Issue.1 , pp. 18-31
    • Meibohm, B.1    Derendorf, H.2


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