In vitro evaluations for pharmacokinetic drug-drug interactions of a novel serotonin-dopamine activity modulator, brexpiprazole

References

• European Medicine Agency (EMA), 2012. Guideline on the investigation of drug interactions. London, UK: EMA. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/07/WC500129606.pdf [Accessed 24 December 2020].
   Google Scholar
• Fahmi, O.A., and Ripp, S.L., 2010. Evaluation of models for predicting drug–drug interactions due to induction. Expert opinion on drug metabolism & toxicology, 6 (11), 1399–1416.
   PubMed Web of Science ®Google Scholar
• Farooq, M., Kelly, E.J., and Unadkat, J.D., 2016. CYP2D6 is inducible by endogenous and exogenous corticosteroids. Drug metabolism and disposition: the biological fate of chemicals, 44 (5), 750–757.
   PubMed Web of Science ®Google Scholar
• Funk, C., et al., 2001. Troglitazone-induced intrahepatic cholestasis by an interference with the hepatobiliary export of bile acids in male and female rats. Correlation with the gender difference in troglitazone sulfate formation and the inhibition of the canalicular bile salt export pump (Bsep) by troglitazone and sufate. Toxicology, 167 (1), 83–98.
   PubMed Web of Science ®Google Scholar
• Garnock-Jones, K.P., 2016. Brexpiprazole: a review in schizophrenia. CNS drugs, 30 (4), 335–342.
   PubMed Web of Science ®Google Scholar
• Giacomini, K.M., et al., International Transporter Consortium. 2010. Membrane transporters in drug development. Nature reviews. Drug discovery, 9 (3), 215–236.
   PubMed Web of Science ®Google Scholar
• Hicks, J.K., et al., Clinical Pharmacogenetics Implementation Consortium, 2015. Clinical pharmacogenetics implementation consortium (CPIC) guideline for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clinical pharmacology and therapeutics, 98 (2), 127–134.
   PubMed Web of Science ®Google Scholar
• Hoffelt, C., and Gross, T., 2016. A review of significant pharmacokinetic drug interactions with antidepressants and their management. The mental health clinician, 6 (1), 35–41.
   PubMedGoogle Scholar
• Ishigooka, J., et al., 2018. Pharmacokinetics and safety of brexpiprazole following multiple-dose administration to Japanese patients with schizophrenia. Journal of clinical pharmacology, 58 (1), 74–80.
   PubMed Web of Science ®Google Scholar
• Izumi, S., Nozaki, Y., Komori, T., Takenaka, O., Maeda, K., Kusuhara, H., and Sugiyama, Y., 2017. Comparison of the predictability of human hepatic clearance for organic anion transporting polypeptide substrate drugs between different in vitro-in vivo extrapolation approaches. Journal of pharmaceutical sciences, 106 (9), 2678–2687.
   PubMed Web of Science ®Google Scholar
• König, J., Müller, F., and Fromm, M.F., 2013. Transporters and drug–drug interactions: important determinants of drug disposition and effects. Pharmacological reviews, 65 (3), 944–966.
   PubMed Web of Science ®Google Scholar
• Madan, A., et al., 1999. Effect of cryopreservation on cytochrome P450 enzyme induction in cultured rat hepatocytes. Drug metabolism and disposition: the biological fate of chemicals, 27 (3), 327–335.
   PubMed Web of Science ®Google Scholar
• Maeda, K., et al., 2014b. Brexpiprazole II: antipsychotic-like and procognitive effects of a novel serotonin-dopamine activity modulator. The journal of pharmacology and experimental therapeutics, 350 (3), 605–614.
   PubMed Web of Science ®Google Scholar
• Maeda, K., et al., 2014a. Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator. Journal of pharmacology and experimental therapeutics, 350 (3), 589–604.
   PubMed Web of Science ®Google Scholar
• Otsuka America Pharmaceutical, Inc. Rexulti (brexpiprazole) tablet, highlights of prescribing information; 2015. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205422s003lbl.pdf [Accessed 24 December 2020].
   Google Scholar
• Pharmaceuticals and Medical Devices Agency. 2019 Guideline on drug interaction for drug development and appropriate provision of information. Available from: https://www.pmda.go.jp/files/000228122.pdf [Accessed 24 December 2020].
   Google Scholar
• Quistorff, B., 1990. Preparation of isolated periportal or perivenous hepatocytes from rat liver. Methods in molecular biology (Clifton, N.J.), 5, 177–187.
   PubMedGoogle Scholar
• Richelson, E., 1997. Pharmacokinetic drug interactions of new antidepressants: a review of the effects on the metabolism of other drugs. Mayo clinic proceedings, 72 (9), 835–847.
   PubMed Web of Science ®Google Scholar
• Sasabe, H., et al., 2021. Pharmacokinetics and metabolism of brexpiprazole, a novel serotonin-dopamine activity modulator and its main metabolite in rat, monkey and human. Xenobiotica.
   Google Scholar
• Shimokawa, Y., et al., 2014. Delamanid does not inhibit or induce cytochrome P450 enzymes in vitro. Biological & pharmaceutical bulletin, 37 (11), 1727–1735.
   PubMed Web of Science ®Google Scholar
• Shirasaka, Y., Sakane, T., and Yamashita, S., 2008. Effect of P-glycoprotein expression levels on the concentration-dependent permeability of drugs to the cell membrane. Journal of pharmaceutical sciences, 97 (1), 553–565.
   PubMed Web of Science ®Google Scholar
• U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research (CDER). 2020. In vitro drug interaction studies – cytochrome P450 enzyme- and transporter-mediated drug interactions guidance for industry. Available from: https://www.fda.gov/media/134582/download [Accessed 24 December 2020].
   Google Scholar
• Venkatakrishnan, K., Obach, R.S., and Rostami-Hodjegan, A., 2007. Mechanism-based inactivation of human cytochrome P450 enzymes: strategies for diagnosis and drug–drug interaction risk assessment. Xenobiotica; the fate of foreign compounds in biological systems, 37 (10-11), 1225–1256.
   PubMed Web of Science ®Google Scholar
• Yoshida, K., et al., 2017. In vitro-in vivo extrapolation of metabolism- and transporter-mediated drug–drug interactions-overview of basic prediction methods. Journal of pharmaceutical sciences, 106 (9), 2209–2213.
   PubMed Web of Science ®Google Scholar
• Yoshikado, T., et al., 2013. Ticlopidine, a cholestatic liver injury-inducible drug, causes dysfunction of bile formation via diminished biliary secretion of phospholipids: involvement of biliary-excreted glutathione-conjugated ticlopidine metabolites. Molecular pharmacology, 83 (2), 552–562.
   PubMed Web of Science ®Google Scholar
• Yu, J., et al., 2018. Risk of clinically relevant pharmacokinetic-based drug–drug Interactions with drugs approved by the U.S. Food and Drug Administration between 2013 and 2016. Drug metabolism and disposition, 46 (6), 835–845.
   PubMed Web of Science ®Google Scholar