{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,17]],"date-time":"2026-01-17T21:23:58Z","timestamp":1768685038771,"version":"3.49.0"},"reference-count":19,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,3,28]],"date-time":"2022-03-28T00:00:00Z","timestamp":1648425600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tirabrutinib (TIRA), a potent and nonreversible oral Bruton tyrosine kinase inhibitor, is evaluated for treatment of certain hematological malignancies and inflammatory diseases. A drug\u2013drug interaction study to evaluate the effect of TIRA on the pharmacokinetics of the oral contraceptive levonorgestrel (LEVO)\/ethinyl estradiol (EE) was conducted in healthy female participants (<jats:italic>N<\/jats:italic>\u00a0=\u00a026). Participants received a single dose of LEVO (150 mcg)\/EE (30 mcg) alone (reference), and on day 12 of a 15\u2010day regimen of TIRA 160\u00a0mg once\u2010daily (test). Intensive blood sampling for determination of LEVO, EE, and TIRA plasma concentrations was conducted, and safety was assessed throughout the study. Pharmacokinetic interactions were evaluated using 90% confidence intervals (CIs) of the geometric least squares mean (GLSM) ratios of the test versus reference treatments. The GLSM (90% CI) ratios of area under the concentration\u2010time curve from zero to infinity (AUC<jats:sub>inf<\/jats:sub>; LEVO: 0.95, 95% CI: 0.88\u20131.03, EE: 1.10, 95% CI: 1.05\u20131.16) and maximum plasma concentration (C<jats:sub>max<\/jats:sub>; LEVO: 0.85, 95% CI: 0.74\u20130.98, EE: 1.07, 95% CI: 0.98\u20131.18) were within the prespecified 0.70 to 1.43 no effect bounds; and the AUC ratios met the stricter 0.80 to 1.25 equivalence bounds. Study treatments were generally well\u2010tolerated. In conclusion, co\u2010administration with TIRA did not alter the exposure of LEVO\/EE, and accordingly LEVO\/EE containing oral contraceptives can serve as a contraception method for participants on TIRA 160\u00a0mg (or lower) daily doses.<\/jats:p>","DOI":"10.1111\/cts.13265","type":"journal-article","created":{"date-parts":[[2022,3,10]],"date-time":"2022-03-10T08:54:06Z","timestamp":1646902446000},"page":"1492-1499","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of the potential for pharmacokinetic interaction between tirabrutinib and levonorgestrel\/ethinyl estradiol in healthy female volunteers"],"prefix":"10.1111","volume":"15","author":[{"given":"Ganesh","family":"Cherala","sequence":"first","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cara","family":"Nelson","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ying","family":"Guo","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anubhav","family":"Mathur","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0465-9577","authenticated-orcid":false,"given":"Thomas","family":"Tarnowski","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4937-2775","authenticated-orcid":false,"given":"Ahmed A.","family":"Othman","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc.  Foster City California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,3,28]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-99-109973"},{"issue":"21","key":"e_1_2_9_3_1","doi-asserted-by":"crossref","first-page":"4502","DOI":"10.1182\/blood.V124.21.4502.4502","article-title":"ONO\u20104059 \u2010 a\u00a0potent and selective reversible Bruton's tyrosine kinase (BTK) inhibitor: single agent, twice daily (BD) dosing and dosing with food results in sustained, high trough levels of ONO\u20104059, translating into 100% tumour remission in a TMD\u20108 xenograft model","volume":"124","author":"Toshio Y","year":"2014","journal-title":"Blood"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01318-8"},{"key":"e_1_2_9_5_1","unstructured":"Pharmaceuticals and Medical Devices Agency.https:\/\/www.pmda.go.jp\/files\/000237315.pdf. Accessed October 8 2021."},{"key":"e_1_2_9_6_1","unstructured":"National Survey of Family Growth 2015\u20132017.The National Center for Health Statistics Centers for Disease Control and Prevention.https:\/\/www.cdc.gov\/nchs\/nsfg\/nsfg_2015_2017_puf.htm. Accessed October 8 2021."},{"key":"e_1_2_9_7_1","unstructured":"Contraceptive Use by Method United Nations Department of Economic and Social Affairs2019. Updated September 30 2021.https:\/\/www.un.org\/development\/desa\/pd\/sites\/www.un.org.development.desa.pd\/files\/files\/documents\/2020\/Jan\/un_2019_contraceptiveusebymethod_databooklet.pdf. Accessed October 6 2021."},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12499"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1848"},{"key":"e_1_2_9_10_1","unstructured":"Study to evaluate the efficacy safety and tolerability of Tirabrutinib in participants with antihistamine\u2010resistant chronic spontaneous urticaria.https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04827589. Accessed October 6 2021."},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.00627"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.14037"},{"key":"e_1_2_9_13_1","volume-title":"Bioanalytical method validation: Guidance for Industry","author":"United States Food and Drug Administration","year":"2018"},{"key":"e_1_2_9_14_1","volume-title":"Design and Analysis of Bioavailability and Bioequivalence Studies","author":"Shein\u2010Chung C","year":"2008"},{"key":"e_1_2_9_15_1","volume-title":"Contraceptive Technology","author":"Trussell J","year":"2018"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2016.07.019"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2016.03.010"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2020.107789"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.13983"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2015-08-664086"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13265","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.13265","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13265","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,23]],"date-time":"2023-08-23T19:25:02Z","timestamp":1692818702000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.13265"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,28]]},"references-count":19,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2022,6]]}},"alternative-id":["10.1111\/cts.13265"],"URL":"https:\/\/doi.org\/10.1111\/cts.13265","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3,28]]},"assertion":[{"value":"2021-12-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-02-26","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-28","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}