{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:45:55Z","timestamp":1786977955555,"version":"build-2736575974"},"reference-count":31,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2020,4,16]],"date-time":"2020-04-16T00:00:00Z","timestamp":1586995200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Allergan plc, Dublin, Ireland"},{"name":"Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The incidence of migraine is higher among women than men and peaks during the reproductive years, when contraceptive medication use is common. Atogepant, a potent, selective antagonist of the calcitonin gene\u2012related peptide receptor\u2014in development for migraine prevention\u2014is thus likely to be used by women taking oral contraceptives. This phase 1, open\u2010label, single\u2010center, 2\u2010period, fixed\u2010sequence study examined the effect of multiple\u2010dose atogepant 60 mg once daily on the single\u2010dose pharmacokinetics of a combination oral contraceptive, ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg (EE\/LNG), in healthy postmenopausal or oophorectomized women. For participants in period 1, a single dose of EE\/LNG was followed by a 7\u2010day washout. In period 2, atogepant was given once daily on days 1\u201017; an oral dose of EE\/LNG was coadministered with atogepant on day 14. Plasma pharmacokinetic parameters for EE and LNG were assessed following administration with and without atogepant. Twenty\u2010six participants aged 45\u201064 years enrolled; 22 completed the study in accordance with the protocol. The area under the concentration\u2010time curve extrapolated to infinity (AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    ) of LNG was increased by 19% when administered with atogepant. Coadministration of atogepant and a single dose of EE\/LNG did not substantially alter the pharmacokinetics of EE; the \u223c19% increase in plasma AUC\n                    <jats:sub>0\u2010\u221e<\/jats:sub>\n                    of LNG is not anticipated to be clinically significant. Overall, atogepant alone and in combination with EE\/LNG was generally well tolerated, with no new safety signals identified.\n                  <\/jats:p>","DOI":"10.1002\/jcph.1610","type":"journal-article","created":{"date-parts":[[2020,4,16]],"date-time":"2020-04-16T08:49:20Z","timestamp":1587026960000},"page":"1157-1165","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Atogepant Has No Clinically Relevant Effects on the Pharmacokinetics of an Ethinyl Estradiol\/Levonorgestrel Oral Contraceptive in Healthy Female Participants"],"prefix":"10.1002","volume":"60","author":[{"given":"Wendy","family":"Ankrom","sequence":"first","affiliation":[{"name":"Research Laboratories Merck &amp; Co, Inc  Kenilworth New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jialin","family":"Xu","sequence":"additional","affiliation":[{"name":"Research Laboratories Merck &amp; Co, Inc  Kenilworth New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010Helene","family":"Vallee","sequence":"additional","affiliation":[{"name":"Research Laboratories Merck &amp; Co, Inc  Kenilworth New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marissa F.","family":"Dockendorf","sequence":"additional","affiliation":[{"name":"Research Laboratories Merck &amp; Co, Inc  Kenilworth New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"Armas","sequence":"additional","affiliation":[{"name":"Celerion Inc  Phoenix Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Boinpally","sequence":"additional","affiliation":[{"name":"Allergan plc  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Chris","family":"Min","sequence":"additional","affiliation":[{"name":"Research Laboratories Merck &amp; Co, Inc  Kenilworth New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,4,16]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12150"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1992.03480010072027"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1526-4610.2001.041007646.x"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-018-0846-2"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.3109\/13625187.2013.814769"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)30293-9"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.55.6.754"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-018-0617-4"},{"key":"e_1_2_14_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-017-0807-1"},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000000831"},{"key":"e_1_2_14_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-018-0003-1"},{"key":"e_1_2_14_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12656"},{"key":"e_1_2_14_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12179"},{"key":"e_1_2_14_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13379"},{"key":"e_1_2_14_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13081"},{"key":"e_1_2_14_17_1","unstructured":"Emgality [package insert].Indianapolis IN:Eli Lilly and Company;2018."},{"key":"e_1_2_14_18_1","unstructured":"Aimovig [package insert].Thousand Oaks CA andEast Hanover NJ:Amgen Inc and Novartis Pharmaceuticals Corporation;2018."},{"key":"e_1_2_14_19_1","unstructured":"Ajovy [package insert].North Wales PA:Teva Pharmaceuticals USA Inc;2018."},{"issue":"15","key":"e_1_2_14_20_1","article-title":"Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b\/3 study (S17.001)","volume":"92","author":"Goadsby PJ","year":"2019","journal-title":"Neurology"},{"key":"e_1_2_14_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/tre.107"},{"key":"e_1_2_14_22_1","unstructured":"Nordette\u201028 [package insert]. Sellersville PA: Teva Women's Health;2012."},{"key":"e_1_2_14_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2016.08.003"},{"key":"e_1_2_14_24_1","unstructured":"US FDA.Clinical Drug Interaction Studies\u2014Study Design Data Analysis and Clinical Implications Guidance for Industry.October 24 2017.https:\/\/www.fda.gov\/media\/82734\/download. Accessed March 30 2020."},{"key":"e_1_2_14_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/humupd\/dmw016"},{"key":"e_1_2_14_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2016.12.007"},{"key":"e_1_2_14_27_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199528030-00003"},{"key":"e_1_2_14_28_1","doi-asserted-by":"publisher","DOI":"10.1042\/bj2670221"},{"issue":"5","key":"e_1_2_14_29_1","first-page":"500","article-title":"Oxidation of 17 alpha\u2010ethynylestradiol by human liver cytochrome P\u2010450","volume":"33","author":"Guengerich FP","year":"1988","journal-title":"Mol Pharmacol"},{"key":"e_1_2_14_30_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.113.054346"},{"key":"e_1_2_14_31_1","doi-asserted-by":"publisher","DOI":"10.1086\/685428"},{"key":"e_1_2_14_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.443"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.1610","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1610","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcph.1610","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.1610","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,5]],"date-time":"2023-09-05T19:19:01Z","timestamp":1693941541000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.1610"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4,16]]},"references-count":31,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2020,9]]}},"alternative-id":["10.1002\/jcph.1610"],"URL":"https:\/\/doi.org\/10.1002\/jcph.1610","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,4,16]]},"assertion":[{"value":"2019-11-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-02-25","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-04-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}