{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T13:51:30Z","timestamp":1788616290206,"version":"build-2803163510"},"reference-count":31,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,5,3]],"date-time":"2023-05-03T00:00:00Z","timestamp":1683072000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Futibatinib, a selective, irreversible fibroblast growth factor receptor 1\u20134 inhibitor, is being investigated for tumors harboring <jats:italic>FGFR<\/jats:italic> aberrations and was recently approved for the treatment of <jats:italic>FGFR2<\/jats:italic> fusion\/rearrangement\u2010positive intrahepatic cholangiocarcinoma. In vitro studies identified cytochrome P450 (CYP) 3A as the major CYP isoform in futibatinib metabolism and indicated that futibatinib is likely a P\u2010glycoprotein (P\u2010gp) substrate and inhibitor. Futibatinib also showed time\u2010dependent inhibition of CYP3A in vitro. Phase I studies investigated the drug\u2010drug interactions of futibatinib with itraconazole (a dual P\u2010gp and strong CYP3A inhibitor), rifampin (a dual P\u2010gp and strong CYP3A inducer), or midazolam (a sensitive CYP3A substrate) in healthy adult participants. Compared with futibatinib alone, coadministration of futibatinib with itraconazole increased futibatinib mean peak plasma concentration and area under the plasma concentration\u2013time curve by 51% and 41%, respectively, and coadministration of futibatinib with rifampin lowered futibatinib mean peak plasma concentration and area under the plasma concentration\u2013time curve by 53% and 64%, respectively. Coadministration of midazolam with futibatinib had no effect on midazolam pharmacokinetics compared with midazolam administered alone. These findings suggest that concomitant use of dual P\u2010gp and strong CYP3A inhibitors\/inducers with futibatinib should be avoided, but futibatinib can be concomitantly administered with other drugs metabolized by CYP3A. Drug\u2010drug interaction studies with P\u2010gp\u2013specific substrates and inhibitors are planned.<\/jats:p>","DOI":"10.1002\/cpdd.1259","type":"journal-article","created":{"date-parts":[[2023,5,3]],"date-time":"2023-05-03T12:03:19Z","timestamp":1683115399000},"page":"966-978","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Evaluation of the Cytochrome P450 3A and P\u2010glycoprotein Drug\u2010Drug Interaction Potential of Futibatinib"],"prefix":"10.1002","volume":"12","author":[{"given":"Ikuo","family":"Yamamiya","sequence":"first","affiliation":[{"name":"Taiho Oncology, Inc. 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