{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T17:41:05Z","timestamp":1789062065976,"version":"build-2803163510"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,8,24]],"date-time":"2022-08-24T00:00:00Z","timestamp":1661299200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,8,24]],"date-time":"2022-08-24T00:00:00Z","timestamp":1661299200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Cancer Chemother Pharmacol"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Fedratinib is an orally administered Janus kinase (JAK) 2\u2013selective inhibitor for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis. In vitro, fedratinib is predominantly metabolized by cytochrome P450 (CYP) 3A4 and to a lesser extent by CYP2C19. Coadministration of fedratinib with CYP3A4 inhibitors is predicted to increase systemic exposure to fedratinib. This study evaluated the effect of multiple doses of the dual CYP3A4 and CYP2C19 inhibitor, fluconazole, on the pharmacokinetics of a single dose of fedratinib.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this non-randomized, fixed-sequence, open-label study, healthy adult participants first received a single oral dose of fedratinib 100\u00a0mg on day 1. Participants then received fluconazole 400\u00a0mg on day 10 and fluconazole 200\u00a0mg once daily on days 11\u201323, with a single oral dose of fedratinib 100\u00a0mg on day 18. Pharmacokinetic parameters were calculated for fedratinib administered with and without fluconazole.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 16 participants completed the study and were included in the pharmacokinetic population. Coadministration of fedratinib with fluconazole increased maximum observed plasma concentration (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>) and area under the plasma concentration\u2013time curve from time 0 to the last quantifiable concentration (AUC<jats:sub>0\u2013t<\/jats:sub>) of fedratinib by 21% and 56%, respectively, compared with fedratinib alone. Single oral doses of fedratinib 100\u00a0mg administered with or without fluconazole were well tolerated.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Systemic exposure after a single oral dose of fedratinib was increased by up to 56% when fedratinib was coadministered with fluconazole compared with fedratinib alone.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registry: Clinicaltrials.gov<\/jats:title>\n                <jats:p>NCT04702464.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00280-022-04464-w","type":"journal-article","created":{"date-parts":[[2022,8,24]],"date-time":"2022-08-24T05:13:12Z","timestamp":1661317992000},"page":"325-334","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Effect of fluconazole on the pharmacokinetics of a single dose of fedratinib in healthy adults"],"prefix":"10.1007","volume":"90","author":[{"given":"Yizhe","family":"Chen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4264-8927","authenticated-orcid":false,"given":"Ken","family":"Ogasawara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Wood-Horrall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Thomas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Thomas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bing","family":"He","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liangang","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongjun","family":"Xue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sekhar","family":"Surapaneni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonidas N.","family":"Carayannopoulos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Palmisano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gopal","family":"Krishna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,8,24]]},"reference":[{"issue":"6","key":"4464_CR1","doi-asserted-by":"publisher","first-page":"667","DOI":"10.1182\/blood-2016-10-695940","volume":"129","author":"W Vainchenker","year":"2017","unstructured":"Vainchenker W, Kralovics R (2017) Genetic basis and molecular pathophysiology of classical myeloproliferative neoplasms. 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YC is an employee of and holds equity ownership in Bristol Myers Squibb. RWH is an employee of Pharmaceutical Product Development (PPD), a contract research organization for this study supported by Bristol Myers Squibb. MarkT is an employee of and holds equity ownership in Bristol Myers Squibb. MichaelT is an employee of and holds equity ownership in Bristol Myers Squibb and has planned, issued, or pending patents with Bristol Myers Squibb. BH is an employee of and holds equity ownership in Bristol Myers Squibb. LL is an employee of and holds equity ownership in Bristol Myers Squibb. YX is an employee of and holds equity ownership in Bristol Myers Squibb. SS is an employee of and holds equity ownership in Bristol Myers Squibb.\u00a0LNC is an employee of and holds equity ownership in Bristol Myers Squibb. SZ is an employee of and holds equity ownership in Bristol Myers Squibb.\u00a0MP is an employee of and holds equity ownership in Bristol Myers Squibb.\u00a0GK is an employee of and holds equity ownership in Bristol Myers Squibb.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interests"}},{"value":"The study was conducted in compliance with the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use\/Good Clinical Practice and applicable regulatory requirements. The protocol complied with Declaration of Helsinki, as well as any applicable guidelines of the USA, the country where the study was conducted. The protocol was submitted to an independent review board (Salus IRB, Austin, TX, USA) for review and written approval.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from participants at screening, prior to the conduct of any study-related procedures.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}