Estimation of contribution of CYP2D6 to tipepidine metabolism in humans and prolongation of the half-life of tipepidine by combination use with a CYP2D6 inhibitor in chimeric mice with humanised liver

References

• Achour B, Barber J, Rostami-Hodjegan A. 2014. Expression of hepatic drug-metabolizing cytochrome p450 enzymes and their intercorrelations: a meta-analysis. Drug Metab Dispos. 42(8):1349–1356. doi: 10.1124/dmd.114.058834.
   PubMed Web of Science ®Google Scholar
• Dehbozorghi S, Bagheri S, Moradi K, Shokraee K, Mohammadi MR, Akhondzadeh S. 2019. Efficacy and safety of tipepidine as adjunctive therapy in children with attention-deficit/hyperactivity disorder: randomized, double-blind, placebo-controlled clinical trial. Psychiatry Clin Neurosci. 73(11):690–696. doi: 10.1111/pcn.12913.
   PubMed Web of Science ®Google Scholar
• Gibiino S, Serretti A. 2012. Paroxetine for the treatment of depression: a critical update. Expert Opin Pharmacother. 13(3):421–431. doi: 10.1517/14656566.2012.652085.
   PubMed Web of Science ®Google Scholar
• Hasegawa M, Tahara H, Inoue R, Kakuni M, Tateno C, Ushiki J. 2012. Investigation of drug-drug interactions caused by human pregnane X receptor-mediated induction of CYP3A4 and CYP2C subfamilies in chimeric mice with a humanized liver. Drug Metab Dispos. 40(3):474–480. doi: 10.1124/dmd.111.042754.
   PubMed Web of Science ®Google Scholar
• Hole K, Arnestad M, Molden E, Haslemo T. 2021. Dose-dependent inhibition of CYP2D6 by bupropion in patients with depression. J Clin Psychopharmacol. 41(3):281–285. doi: 10.1097/JCP.0000000000001387.
   PubMed Web of Science ®Google Scholar
• Honda S, Kawaura K, Soeda F, Shirasaki T, Takahama K. 2011. The potent inhibitory effect of tipepidine on marble-burying behavior in mice. Behav Brain Res. 216(1):308–312. doi: 10.1016/j.bbr.2010.08.010.
   PubMed Web of Science ®Google Scholar
• Hoobehfekr S, Moghaddam HS, Shalbafan M, Hashemi MG, Pirmoradi MM, Sakenian A, Poopak A, Kashefinejad S, Yarahmadi M, Akhondzadeh S. 2021. Efficacy and safety of tipepidine as adjunctive therapy in major depressive disorder: a randomized, double-blind, placebo-controlled clinical trial. Psychiatry Clin Neurosci. 75(2):57–62. doi: 10.1111/pcn.13180.
   PubMed Web of Science ®Google Scholar
• Inoue S, Ohtani H, Tsujimoto M, Hori S, Sawada Y. 2007. Development of a pharmacokinetic model to optimize the dosage regimen of TS-1, a combination preparation of tegafur, gimeracil and oteracil potassium. Drug Metab Pharmacokinet. 22(3):162–168. doi: 10.2133/dmpk.22.162.
   PubMed Web of Science ®Google Scholar
• Kakuda TN, Crauwels H, Opsomer M, Tomaka F, van de Casteele T, Vanveggel S, Iterbeke K, de Smedt G. 2015. Darunavir/cobicistat once daily for the treatment of HIV. Expert Rev anti Infect Ther. 13(6):691–704. doi: 10.1586/14787210.2015.1033400.
   PubMed Web of Science ®Google Scholar
• Kakuni M, Yamasaki C, Tachibana A, Yoshizane Y, Ishida Y, Tateno C. 2013. Chimeric mice with humanized livers: a unique tool for in vivo and in vitro enzyme induction studies. Int J Mol Sci. 15(1):58–74. doi: 10.3390/ijms15010058.
   PubMed Web of Science ®Google Scholar
• Kato S, Shah A, Plesescu M, Miyata Y, Bolleddula J, Chowdhury S, Zhu X. 2020. Prediction of human disproportionate and biliary excreted metabolites using chimeric mice with humanized liver. Drug Metab Dispos. 48(10):934–943. doi: 10.1124/dmd.120.000128.
   PubMed Web of Science ®Google Scholar
• Kawaura K, Ogata Y, Inoue M, Honda S, Soeda F, Shirasaki T, Takahama K. 2009. The centrally acting non-narcotic antitussive tipepidine produces antidepressant-like effect in the forced swimming test in rats. Behav Brain Res. 205(1):315–318. doi: 10.1016/j.bbr.2009.07.004.
   PubMed Web of Science ®Google Scholar
• Kawaura K, Miki R, Urashima Y, Honda S, Shehata AM, Soeda F, Shirasaki T, Takahama K. 2011. Tipepidine enhances the antinociceptive-like action of carbamazepine in the acetic acid writhing test. Eur J Pharmacol. 651(1-3):106–108. doi: 10.1016/j.ejphar.2010.10.086.
   PubMed Web of Science ®Google Scholar
• Maldonado R. 2013. Comparison of the pharmacokinetics and clinical efficacy of new extended-release formulations of methylphenidate. Expert Opin Drug Metab Toxicol. 9(8):1001–1014. doi: 10.1517/17425255.2013.786041.
   PubMed Web of Science ®Google Scholar
• Martignoni M, Groothuis GM, de Kanter R. 2006. Species differences between mouse, rat, dog, monkey and human CYP-mediated drug metabolism, inhibition and induction. Expert Opin Drug Metab Toxicol. 2(6):875–894. doi: 10.1517/17425255.2.6.875.
   PubMed Web of Science ®Google Scholar
• Miki R, Honda I, Hamasaki R, Kawahara R, Soeda F, Shirasaki T, Misumi S, Takahama K. 2019. Effects of tipepidine on MK-801-induced cognitive impairment in mice. Brain Res. 1710:230–236. doi: 10.1016/j.brainres.2018.12.032.
   PubMed Web of Science ®Google Scholar
• Miyamoto M, Iwasaki S, Chisaki I, Nakagawa S, Amano N, Hirabayashi H. 2017. Comparison of predictability for human pharmacokinetics parameters among monkeys, rats, and chimeric mice with humanised liver. Xenobiotica. 47(12):1052–1063. doi: 10.1080/00498254.2016.1265160.
   PubMed Web of Science ®Google Scholar
• Patel K, Allen S, Haque MN, Angelescu I, Baumeister D, Tracy DK. 2016. Bupropion: a systematic review and meta-analysis of effectiveness as an antidepressant. Ther Adv Psychopharmacol. 6(2):99–144. doi: 10.1177/2045125316629071.
   PubMed Web of Science ®Google Scholar
• Pope LE, Khalil MH, Berg JE, Stiles M, Yakatan GJ, Sellers EM. 2004. Pharmacokinetics of dextromethorphan after single or multiple dosing in combination with quinidine in extensive and poor metabolizers. J Clin Pharmacol. 44(10):1132–1142. doi: 10.1177/0091270004269521.
   PubMed Web of Science ®Google Scholar
• Saito T, Yamashita Y, Tomoda A, Okada T, Umeuchi H, Iwamori S, Shinoda S, Mizuno-Yasuhira A, Urano H, Nishino I, et al. 2020. Using the drug repositioning approach to develop a novel therapy, tipepidine hibenzate sustained-release tablet (TS-141), for children and adolescents with attention-deficit/hyperactivity disorder. BMC Psychiatry. 20(1):530. doi: 10.1186/s12888-020-02932-2.
   PubMed Web of Science ®Google Scholar
• Sanoh S, Naritomi Y, Fujimoto M, Sato K, Kawamura A, Horiguchi A, Sugihara K, Kotake Y, Ohshita H, Tateno C, et al. 2015. Predictability of plasma concentration-time curves in humans using single-species allometric scaling of chimeric mice with humanized liver. Xenobiotica. 45(7):605–614. doi: 10.3109/00498254.2015.1007112.
   PubMed Web of Science ®Google Scholar
• Sasaki T, Hashimoto K, Tachibana M, Kurata T, Okawada K, Ishikawa M, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, et al. 2014a. Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study. Neuropsychiatr Dis Treat. 10:147–151. doi: 10.2147/NDT.S58480.
   PubMed Web of Science ®Google Scholar
• Sasaki T, Hashimoto K, Tachibana M, Kurata T, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, et al. 2014b. Tipepidine in adolescent patients with depression: a 4 week, open-label, preliminary study. Neuropsychiatr Dis Treat. 10:719–722. doi: 10.2147/NDT.S63075.
   PubMed Web of Science ®Google Scholar
• Soeda F, Fujieda Y, Kinoshita M, Shirasaki T, Takahama K. 2016. Centrally acting non-narcotic antitussives prevent hyperactivity in mice: involvement of GIRK channels. Pharmacol Biochem Behav. 144:26–32. doi: 10.1016/j.pbb.2016.02.006.
   PubMed Web of Science ®Google Scholar
• Stringer RA, Strain-Damerell C, Nicklin P, Houston JB. 2009. Evaluation of recombinant cytochrome P450 enzymes as an in vitro system for metabolic clearance predictions. Drug Metab Dispos. 37(5):1025–1034. doi: 10.1124/dmd.108.024810.
   PubMed Web of Science ®Google Scholar
• Suzuki A, Iida I, Hirota M, Akimoto M, Higuchi S, Suwa T, Tani M, Ishizaki T, Chiba K. 2003. CYP isoforms involved in the metabolism of clarithromycin in vitro: comparison between the identification from disappearance rate and that from formation rate of metabolites. Drug Metab Pharmacokinet. 18(2):104–113. doi: 10.2133/dmpk.18.104.
   PubMedGoogle Scholar
• Takaoka N, Sanoh S, Okuda K, Kotake Y, Sugahara G, Yanagi A, Ishida Y, Tateno C, Tayama Y, Sugihara K, et al. 2018. Inhibitory effects of drugs on the metabolic activity of mouse and human aldehyde oxidases and influence on drug-drug interactions. Biochem Pharmacol. 154:28–38. doi: 10.1016/j.bcp.2018.04.017.
   PubMed Web of Science ®Google Scholar
• Tateno C, Yoshizane Y, Saito N, Kataoka M, Utoh R, Yamasaki C, Tachibana A, Soeno Y, Asahina K, Hino H, et al. 2004. Near completely humanized liver in mice shows human-type metabolic responses to drugs. Am J Pathol. 165(3):901–912. doi: 10.1016/S0002-9440(10)63352-4.
   PubMed Web of Science ®Google Scholar
• Taylor CP, Traynelis SF, Siffert J, Pope LE, Matsumoto RR. 2016. Pharmacology of dextromethorphan: relevance to dextromethorphan/quinidine (Nuedexta®) clinical use. Pharmacol Ther. 164:170–182. doi: 10.1016/j.pharmthera.2016.04.010.
   PubMed Web of Science ®Google Scholar
• Todor I, Popa A, Neag M, Muntean D, Bocsan C, Buzoianu A, Vlase L, Gheldiu AM, Chira R, Briciu C. 2015. The influence of paroxetine on the pharmacokinetics of atomoxetine and its main metabolite. Clujul Med. 88(4):513–520. doi: 10.15386/cjmed-488.
   PubMedGoogle Scholar
• VandenBrink BM, Foti RS, Rock DA, Wienkers LC, Wahlstrom JL. 2012. Prediction of CYP2D6 drug interactions from in vitro data: evidence for substrate-dependent inhibition. Drug Metab Dispos. 40(1):47–53. doi: 10.1124/dmd.111.041210.
   PubMed Web of Science ®Google Scholar
• Walsky RL, Obach RS, Gaman EA, Gleeson JP, Proctor WR. 2005. Selective inhibition of human cytochrome P4502C8 by montelukast. Drug Metab Dispos. 33(3):413–418. doi: 10.1124/dmd.104.002766.
   PubMed Web of Science ®Google Scholar
• Yu AM, Haining RL. 2006. Expression, purification, and characterization of mouse CYP2d22. Drug Metab Dispos. 34(7):1167–1174. doi: 10.1124/dmd.105.008870.
   PubMed Web of Science ®Google Scholar