{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T20:20:39Z","timestamp":1790713239485,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,2,16]],"date-time":"2022-02-16T00:00:00Z","timestamp":1644969600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Ubrogepant is an oral calcitonin gene\u2013related peptide receptor antagonist approved for the treatment of acute migraine headaches. Ubrogepant demonstrated efficacy and safety in 2 pivotal phase 3 studies (N = 2240) that led to its approval. Here, we report the pharmacokinetics and safety results from a phase 1 study in which participants with severe (n = 4), moderate (n = 8), or mild (n = 8) hepatic impairment and matched participants with normal hepatic function (n = 8) were administered a single dose of 100 mg of ubrogepant. Twenty\u2010eight participants aged 36 to 70 years were enrolled and completed the study. In participants with mild, moderate, or severe hepatic impairment, ubrogepant systemic exposure (area under the plasma concentration\u2013time curve) increased by 7%, 52%, and 115%, respectively, compared with participants with normal hepatic function (\u22481600 ng \u2022 h\/mL). Peak exposure increased by 1%, 18%, and 26%, respectively, in participants with mild, moderate, or severe hepatic impairment compared to those with normal hepatic function (\u2248400 ng\/mL). Plasma protein binding did not change significantly across groups. No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Dose adjustment (50 mg) is recommended for patients with severe hepatic impairment. Single doses of ubrogepant 100 mg were safe, and all the enrolled participants, regardless of hepatic function, completed the study.<\/jats:p>","DOI":"10.1002\/cpdd.1066","type":"journal-article","created":{"date-parts":[[2022,2,17]],"date-time":"2022-02-17T04:09:03Z","timestamp":1645070943000},"page":"857-864","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Single\u2010Dose Pharmacokinetics and Safety of Ubrogepant in Adults With Hepatic Impairment: Results From an Open\u2010Label, Phase 1 Trial"],"prefix":"10.1002","volume":"11","author":[{"given":"Ramesh","family":"Boinpally","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacometrics AbbVie Inc. Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaifeng","family":"Lu","sequence":"additional","affiliation":[{"name":"Biostatistics AbbVie Inc. Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,2,16]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01264-5"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102410368444"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000000831"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa030505"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3181b87942"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1021\/ml900016y"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12728"},{"key":"e_1_2_8_9_1","first-page":"160","article-title":"Characterization of ubrogepant: a potent and selective antagonist of the human calcitonin gene related peptide receptor","volume":"373","author":"Moore E","year":"2020","journal-title":"J Pharmacol Exp Ther"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813049"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.16711"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1021"},{"key":"e_1_2_8_13_1","first-page":"S8","article-title":"Pharmacology and pharmacokinetics of ubrogepant: a potent, selective calcitonin gene\u2010related peptide receptor antagonist for the acute treatment of migraine","volume":"69","author":"Blumenfeld AM","year":"2020","journal-title":"J Fam Pract"},{"key":"e_1_2_8_14_1","first-page":"1","article-title":"Effects of CYP3A4 and P\u2010glycoprotein inhibition or induction on the pharmacokinetics of ubrogepant in healthy adults: two phase 1, open\u2010label, fixed\u2010sequence, single\u2010center, crossover trials","volume":"4","author":"Jakate A","year":"2021","journal-title":"Cephalalgia Rep"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.128"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1696"},{"key":"e_1_2_8_17_1","doi-asserted-by":"crossref","first-page":"P1.10","DOI":"10.1212\/WNL.92.15_supplement.P1.10-014","article-title":"Single and multiple doses of ubrogepant are not associated with a clinically significant elevation of alanine aminotransferase in healthy adult males (P1.10\u2010014)","volume":"92","author":"Bondiskey P","year":"2019","journal-title":"Neurology"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1066","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1066","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1066","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T20:11:22Z","timestamp":1726690282000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1066"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,2,16]]},"references-count":16,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["10.1002\/cpdd.1066"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1066","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,2,16]]},"assertion":[{"value":"2021-10-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-02-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}