{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:40:05Z","timestamp":1786977605984,"version":"build-2736575974"},"reference-count":18,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2022,8,8]],"date-time":"2022-08-08T00:00:00Z","timestamp":1659916800000},"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":[[2022,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Eluxadoline is a mixed \u03bc\u2010opioid, \u03ba\u2010opioid receptor agonist, and \u03b4\u2010opioid receptor antagonist, approved in the United States for adults with diarrhea\u2010predominant irritable bowel syndrome. This phase 1, single\u2010center, open\u2010label, single\u2010sequence study was conducted on 30 healthy participants to establish whether steady\u2010state eluxadoline increases systemic exposure of the cytochrome P450 (CYP) 3A4 substrate midazolam. Participants received oral midazolam 4 mg on day 1 with a 7\u2010day washout period. On days 8\u201016, oral eluxadoline 100\u00a0mg was administered twice daily. On day 15, midazolam 4 mg was coadministered with the eluxadoline 100\u2010mg morning dose. Primary outcome measures were pharmacokinetic parameters of midazolam and 1\u2010hydroxy\u2010midazolam. The midazolam and 1\u2010hydroxy\u2010midazolam geometric mean ratios and 90%CIs for maximum plasma drug concentration were 99.0% (91.6\u2010107.0) and 113.8% (104.9\u2010123.5), respectively, and area under the plasma concentration\u2013time curves were 90.5% (83.9\u201097.6) and 105.1% (99.8\u2010110.7), respectively, demonstrating the 2 treatments were bioequivalent, and there was no clinically significant drug interaction. All treatment\u2010emergent adverse events were treatment related, mild in intensity, with no serious adverse events. These results suggest that eluxadoline has no clinically significant effect on CYP3A4 activity and is, therefore, unlikely to affect the pharmacokinetics of other CYP3A4 substrates.<\/jats:p>","DOI":"10.1002\/cpdd.1150","type":"journal-article","created":{"date-parts":[[2022,8,8]],"date-time":"2022-08-08T05:03:20Z","timestamp":1659935000000},"page":"1341-1348","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["An Open\u2010Label Study to Evaluate the Effect of Eluxadoline on the Single\u2010Dose Pharmacokinetics of Midazolam in Healthy Participants"],"prefix":"10.1002","volume":"11","author":[{"given":"Ramesh","family":"Boinpally","sequence":"first","affiliation":[{"name":"AbbVie Inc  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"McGeeney","sequence":"additional","affiliation":[{"name":"AbbVie Inc  North Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Kaczynski","sequence":"additional","affiliation":[{"name":"AbbVie Inc  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darren","family":"Weissman","sequence":"additional","affiliation":[{"name":"AbbVie Inc  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,8,8]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S127405"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2012.02068.x"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-015-0436-4"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/17474124.2017.1298442"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bcp.2014.09.015"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1505180"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14031"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2016.542"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000000327"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/CEG.S123621"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.442"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.964"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.453"},{"issue":"1","key":"e_1_2_11_15_1","first-page":"557","article-title":"Use of midazolam as a human cytochrome P450 3A probe: II. Characterization of inter\u2010 and intraindividual hepatic CYP3A variability after liver transplantation","volume":"271","author":"Thummel KE","year":"1994","journal-title":"J Pharmacol Exp Ther"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0014-2999(98)00607-4"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.7"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0756-7"},{"issue":"7","key":"e_1_2_11_19_1","first-page":"438","article-title":"Eluxadoline (Viberzi): a mu\u2010opioid receptor agonist for the treatment of irritable bowel syndrome with diarrhea","volume":"42","author":"Maltz F","year":"2017","journal-title":"P T"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1150","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1150","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1150","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T05:50:54Z","timestamp":1692597054000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1150"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,8]]},"references-count":18,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2022,11]]}},"alternative-id":["10.1002\/cpdd.1150"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1150","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,8]]},"assertion":[{"value":"2022-04-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-05","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-08-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}