Translational PK-PD modelling of molecular target modulation for the AMPA receptor positive allosteric modulator Org 26576

Psychopharmacology

Volumn 218, Issue 4, 2011, Pages 713-724

  Bursi, Roberta ^a   Erdemli, Gul ^b   Campbell, Robert ^b   Hutmacher, Matthew M ^c   Kerbusch, Thomas ^b   Spanswick, David ^d   Jeggo, Ross ^d   Nations, Kari R ^e   Dogterom, Peter ^f   Schipper, Jacques ^f   Shahid, Mohammed ^g  

^a Clinical PKPD   (Netherlands)

^b Schering Plough ^*  (Netherlands)

^c ANN ARBOR PHARMACOMETRICS GROUP   (United States)

^d NEUROSOLUTIONS LTD   (United Kingdom)

^e MERCK RESEARCH LABORATORIES   (United States)

^f Process Development and Commercialization   (Netherlands)

^g MSD   (United Kingdom)

Author keywords

ADHD; AMPA receptor positive allosteric modulator; Depression; Org 26576; PK PD modelling and simulation; Schizophrenia; Translational pharmacometrics

Indexed keywords

8,9,9A,10 TETRAHYDRO 5H,7H PYRIDO[3,2 F]PYRROLO[2,1 C][1,4]OXAZEPIN 5 ONE; AMPA RECEPTOR; AMPA RECEPTOR AGONIST; ORG 26576; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CEREBROSPINAL FLUID LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG RESPONSE; DRUG TARGETING; HIPPOCAMPUS; HUMAN; MAJOR DEPRESSION; MALE; MORNING DOSAGE; NONHUMAN; PRIORITY JOURNAL; PSYCHOPHARMACOLOGY; RAT; SIMULATION; SINGLE DRUG DOSE;

EID: 82955237233     PISSN: 00333158     EISSN: 14322072     Source Type: Journal    
DOI: 10.1007/s00213-011-2365-6     Document Type: Article

References (43)

1. AC Arai M Kessler 2007 Pharmacology of ampakine modulators: from AMPA receptors to synapses and behaviour Curr Drug Targets 8 583 602 17504103 10.2174/138945007780618490 1:CAS:528:DC%2BD2sXlsVWmurk%3D (Pubitemid 46785059)
2. CF Bigge 1999 Ionotropic glutamate receptors Curr Opin Chem Biol 3 441 447 10419857 10.1016/S1367-5931(99)80065-9 1:CAS:528:DyaK1MXlt1ejur4%3D (Pubitemid 29376106)
3. D Bowie 2008 Ionotropic glutamate receptors & CNS disorders CNS Neurol Disord Drug Targets 7 2 129 143 18537642 10.2174/187152708784083821 1:CAS:528:DC%2BD1cXlslCitL0%3D
4. BV Broberg BY Glenthøj R Dias DB Larsen CK Olsen 2009 Reversal of cognitive deficits by an ampakine (CX516) and sertindole in two animal models of schizophrenia-sub-chronic and early postnatal PCP treatment in attentional set-shifting Psychopharmacology 206 4 631 640 19390843 10.1007/s00213-009-1540-5 1:CAS:528:DC%2BD1MXkvFGjsb8%3D
5. T Damgaard DB Larsen SL Hansen B Grayson JC Neill N Plath 2010 Positive modulation of alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptors reverses sub-chronic PCP-induced deficits in the novel object recognition task in rats Behav Brain Res 207 1 144 150 19822174 10.1016/j.bbr.2009.09.048 1:CAS:528:DC%2BD1MXhsVymtb7I
6. M Danhof ECM de Lange OE Della Pasqua BA Ploeger RA Voskuyl 2008 Mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modeling in translational drug research Trends Pharmacol Sci 29 186 191 18353445 10.1016/j.tips.2008.01.007 1:CAS:528:DC%2BD1cXksVehsrw%3D
7. ECM de Lange M Danhof 2002 Considerations in the use of cerebrospinal fluid pharmacokinetics to predict brain target concentrations in the clinical setting: implications of the barriers between blood and brain Clin Pharmacokinet 41 691 703 12162757 10.2165/00003088-200241100-00001 (Pubitemid 34948192)
8. R Dingledine K Borges D Bowie SF Traynelis 1999 The glutamate receptor ion channels Pharmacol Rev 51 1 7 61 10049997 1:CAS:528:DyaK1MXitFWgurs%3D (Pubitemid 29113865)
9. G Erdemli LH Smith M Sammons R Jeggo M Shahid 2007 Org 26576, a novel positive allosteric modulator, potentiates AMPA receptor responses in hippocampal neurones J Neuropsychopharmacol 21 A51
10. DC Goff L Leahy I Berman T Posever L Herz AC Leon SA Johnson G Lynch 2001 A placebo-controlled pilot study of the ampakine CX516 added to clozapine in schizophrenia J Clin Psycopharmacol 21 484 487 10.1097/00004714-200110000-00005 1:CAS:528:DC%2BD3MXnslSlsr4%3D (Pubitemid 32937430)
11. DC Goff JS Lambert AC Leon MF Green AL Miller J Patel T Manschreck O Freudenreich SA Johnson 2008 A placebo-controlled add-on trial of the ampakine, CX516, for cognitive deficits in schizophrenia Neuropsychopharmacol 33 465 472 10.1038/sj.npp.1301444 1:CAS:528:DC%2BD1cXmsFSmsQ%3D%3D
12. E Hamlyn L Brand M Shahid BH Harvey 2009 The ampakine, Org 26576, bolsters early spatial reference learning and retrieval in the Morris water maze: a subchronic, dose-ranging study in rats Behav Pharmacol 20 7 662 667 19741506 10.1097/FBP.0b013e328331ba1b 1:CAS:528:DC%2BD1MXhtFOhtr%2FK
13. RE Hampson G Rogers G Lynch SA Deadwyler 1998 Facilitative effects of the ampakine CX516 on short-term memory in rats: enhancement of delayed-no match-to-sample performance J Neurosci 18 2740 2747 9502831 1:CAS:528: DyaK1cXitFCjsLc%3D
14. RE Hampson G Rogers G Lynch SA Deadwyler 1998 Facilitative effects of the ampakine CX516 on short-term memory in rats: correlations with hippocampal neuronal activity J Neurosci 18 2748 2763 9502832 1:CAS:528:DyaK1cXitFCjsb4%3D (Pubitemid 28141820)
15. Hutmacher MM, Bursi R, Chapel S, Kerbusch T (2008) Implications for animal-human scaling of the parallel elimination profile PK model. Abstract 1374, Population Approach Group Europe, 17th Meeting, 18-20 June, Marseille, France
16. I Ito S Tanabe A Kohda H Sugiyama 1990 Allosteric potentiation of quisqualate receptors by a nootropic drug aniracetam J Physiol 424 533 543 1975272 1:CAS:528:DyaK3cXitFSqs7w%3D (Pubitemid 20175172)
17. RD Jeggo Y Wang D Jordan AG Ramage 2007 Activation of 5-HT1B and 5-HT1D receptors in the rat nucleus tractus solitarius: opposing action on neurones that receive an excitatory vagal C-fibre afferent input Br J Pharmacol 150 987 995 17339842 10.1038/sj.bjp.0707169 1:CAS:528:DC%2BD2sXkt1Chsrs%3D (Pubitemid 46625089)
18. SA Johnson NT Luu TA Herbst R Knapp D Lutz A Arai GA Rogers G Lynch 1999 Synergistic interactions between ampakines and antipsychotic drugs L Pharmacol Exp Ther 289 1 392 397 1:CAS:528:DyaK1MXit1KhtL8%3D (Pubitemid 29156054)
19. 14C-2-deoxyglucose autoradiography Neuropharmacology 49 254 264 15993447 10.1016/j.neuropharm.2005.03.011 1:CAS:528:DC%2BD2MXlvFehtLY%3D (Pubitemid 40933763)
20. JN Kew JA Kemp 2005 Ionotropic and metabotropic glutamate receptor structure and pharmacology Psychopharmacology 179 1 4 29 15731895 10.1007/s00213-005-2200-z 1:CAS:528:DC%2BD2MXjtV2itbY%3D (Pubitemid 40576690)
21. RJ Knapp R Goldenberg C Shuck A Cecil J Watkins C Miller G Crites E Malatynska 2002 Antidepressant activity of memory-enhancing drugs in the reduction of submissive behaviour model Eur J Pharmacol 440 1 27 35 11959085 10.1016/S0014-2999(02)01338-9 1:CAS:528:DC%2BD38XivVSjurs%3D (Pubitemid 34312035)
22. J Larson CN Quach BQ LeDuc A Nguyen GA Rogers G Lynch 1996 Effects of an AMPA receptor modulator on methamphetamine-induced hyperactivity in rats Brain Res 738 353 356 8955535 10.1016/S0006-8993(96)01049-9 1:CAS:528: DyaK28Xms1ejs70%3D (Pubitemid 26378934)
23. X Li JP Tizzano K Griffey M Clay T Lindstrom P Skolnick 2001 Antidepressant-like actions of an AMPA receptor potentiator (LY392098) Neuropharmacology 40 1028 1033 11406194 10.1016/S0028-3908(00)00194-5 1:CAS:528:DC%2BD3MXkt1KisL4%3D (Pubitemid 32530609)
24. G Lynch 2004 AMPA receptor modulators as cognitive enhancers Curr Opin Pharmacol 4 4 11 15018832 10.1016/j.coph.2003.09.009 1:CAS:528: DC%2BD2cXpsVCquw%3D%3D (Pubitemid 38145831)
25. G Lynch 2006 Glutamate-based therapeutic approaches: ampakines Curr Opin Pharmacol 6 82 88 16361116 10.1016/j.coph.2005.09.005 1:CAS:528: DC%2BD28XmsVyntg%3D%3D (Pubitemid 43103823)
26. G Lynch CM Gall 2006 Ampakines and the threefold path to cognitive enhancement Trends Neurosci 29 554 562 16890999 10.1016/j.tins.2006.07.007 1:CAS:528:DC%2BD28XpvV2nurs%3D (Pubitemid 44416457)
27. DE Mager WJ Jusko 2008 Development of translational pharmacokinetic- pharmacodynamic models Clin Pharm Ther 83 909 912 10.1038/clpt.2008.52 1:CAS:528:DC%2BD1cXlvFOrtb0%3D (Pubitemid 351704927)
28. SP Mankoff C Brander S Ferrone FM Marincola 2004 Lost in translation: obstacles to translational medicine J Transl Med 2 1 5 10.1186/1479-5876-2-14 (Pubitemid 39130358)
29. G Nikisch P Baumann B Kiessling M Reinert G Wiedemann J Kehr AA Mathé M Piel F Roesch H Weisser P Schneider A Hertel 2010 Relationship between dopamine D2 receptor occupancy, clinical response, and drug and monoamine metabolites levels in plasma and cerebrospinal fluid. A pilot study in patients suffering from first-episode schizophrenia treated with quetiapine J Psychiatr Res 44 754 759 20176367 10.1016/j.jpsychires.2010.02.004
30. CK Olsen M Kreilgaard M Didriksen 2006 Positive modulation of glutamatergic receptors potentiates the suppressive effects of antipsychotics on conditioned avoidance responding in rats Pharmacol Biochem Behav 84 2 259 265 16782180 10.1016/j.pbb.2006.05.006 1:CAS:528:DC%2BD28Xns1GltLY%3D (Pubitemid 44107482)
31. MJ O'Neill D Bleakman DM Zimmerman ES Nisenbaum 2004 AMPA receptor potentiators for the treatment of CNS disorders Curr Drug Targets CNS Neurol Disord 3 3 181 194 15180479 10.2174/1568007043337508 (Pubitemid 38854913)
32. MJ O'Neill TK Murray K Whalley MA Ward CA Hicks S Woodhouse DJ Osborne P Skolnick 2004 Neurotrophic actions of the novel AMPA receptor potentiator LY404187, in rodent models of Parkinson's disease Eur J Pharmacol 486 163 174 14975705 10.1016/j.ejphar.2003.12.023 (Pubitemid 38224527)
33. Paxinos G, Watson C (1982) The rat brain in stereotaxic coordinates. Academic Press, Sidney, p 154
34. LJ Porrino JB Daunais GA Rogers RE Hampson SA Deadwyler 2005 Facilitation of task performance and removal of the effects of sleep deprivation by an ampakine (CX717) in nonhuman primates PLoS Biol 3 1639 1652 10.1371/journal. pbio.0030299 1:CAS:528:DC%2BD2MXhtVGhtbnP (Pubitemid 41306447)
35. LB Sheiner J-L Steimer 2000 Pharmacokinetic/pharmacodynamic modeling in drug development Annu Rev Pharacol Toxicol 40 67 95 10.1146/annurev.pharmtox.40. 1.67 1:CAS:528:DC%2BD3cXjs1yhsrg%3D (Pubitemid 30340674)
36. XW Su XY Li M Banasr JW Koo M Shahid B Henry RS Duman 2009 Chronic treatment with AMPA receptor potentiator Org 26576 increases neuronal cell proliferation and survival in adult rodent hippocampus Psychopharmacology 206 2 215 222 19603152 10.1007/s00213-009-1598-0 1:CAS:528:DC%2BD1MXhtVCnsLzO
37. PL Tierney AM Thierry J Glowinski JM Deniau Y Gioanni 2008 Dopamine modulates temporal dynamics of feedforward inhibition in rat prefrontal cortex in vivo Cereb Cortex 18 2251 2262 18222936 10.1093/cercor/bhm252 1:STN:280:DC%2BD1cngs1yrsw%3D%3D
38. J Vandergriff K Huff A Bond D Lodge 2001 Potentiation of responses to AMPA on central neurones by LY392098 and LY404187 in vivo Neuropharmacol 40 1003 1009 10.1016/S0028-3908(01)00031-4 1:CAS:528:DC%2BD3MXkt1Kis7k%3D (Pubitemid 32530606)
39. K Venkatakrishnan E Tseng FR Nelson H Rollema JL French IV Kaplan WE Horner MA Gibbs 2007 Central nervous system pharmacokinetics of the Mdr1 P-glycoprotein substrate CP-615,003: intersite differences and implications for human receptor occupancy projections from cerebrospinal fluid exposures Drug Metab Dispos 35 1341 1349 17470526 10.1124/dmd.106.013953 1:CAS:528: DC%2BD2sXosVKqtbk%3D (Pubitemid 47121775)
40. U Wählby EN Jonsson MO Karlsson 2001 Assessment of actual significance levels for covariate effects in NONMEM J Pharmacokinet Pharmacodyn 28 3 231 251 11468939 10.1023/A:1011527125570 (Pubitemid 32643366)
41. J Watson S Wright A Lucas KL Clarke J Viggers S Cheetham P Jeffrey R Porter KD Read 2009 Receptor occupancy and brain free fraction Drug Metab Dispos 37 753 760 19158315 10.1124/dmd.108.022814 1:CAS:528:DC%2BD1MXktVSku78%3D
42. E Wezenberg RJ Verkes GSF Ruigt W Hulstijn BGC Sabbe 2007 Acute effects of the ampakine farampator on memory and information processing in healthy elderly volunteers Neuropsychopharmacol 32 1272 1283 10.1038/sj.npp.1301257 1:CAS:528:DC%2BD2sXltlaqtbc%3D (Pubitemid 46788860)
43. ML Woolley KA Waters JE Gartlon LP Lacroix C Jennings F Shaughnessy A Ong DJ Pemberton MH Harries E Southam DN Jones LA Dawson 2009 Evaluation of the pro-cognitive effects of the AMPA receptor positive modulator, 5-(1-piperidinylcarbonyl)-2,1,3-benzoxadiazole (CX691), in the rat Psychopharmacology 202 1-3 343 354 18795266 10.1007/s00213-008-1325-2 1:CAS:528:DC%2BD1MXht1egs7g%3D