{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T19:53:51Z","timestamp":1774468431728,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T00:00:00Z","timestamp":1620086400000},"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":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Atogepant is a selective, oral calcitonin gene\u2013related peptide receptor antagonist in development for preventive treatment of migraine. This randomized, double\u2010blind, phase 1 crossover study evaluated the cardiac repolarization effect of a single supratherapeutic (300 mg) atogepant dose vs placebo in healthy adults. Moxifloxacin 400 mg was the open\u2010label active control. The primary end point was a change from baseline in Fridericia\u2010corrected QT intervals (\u0394QTcF). Sixty participants were randomized to atogepant 300 mg, placebo, and moxifloxacin; 59 (98.3%) completed all interventions. Assay sensitivity was confirmed: lower 90% confidence interval limit for QTcF interval change from baseline (\u0394\u0394QTcF) for moxifloxacin was &gt;5 millisecond vs placebo at prespecified 2\u2010, 3\u2010, and 4\u2010hour time points. Following single\u2010dose atogepant 300 mg, mean atogepant \u0394\u0394QTcF and upper 90% confidence interval limits were lower than the 10\u2010millisecond threshold at all time points. Atogepant mean peak plasma concentration was 3197 ng\/mL, area under the concentration\u2010time curve from time 0 to time t was 16\u00a0640 ng \u2022 h\/mL, area under the concentration\u2010time curve from time 0 to 24 hours was 16\u00a0607 ng \u2022 h\/mL, and median time to peak plasma concentration was 2.1 hours. The incidence of adverse events was low; no serious adverse events or elevations of liver enzymes were reported. Overall, a single supratherapeutic dose of atogepant was safe and did not impact cardiac repolarization in healthy participants.<\/jats:p>","DOI":"10.1002\/cpdd.940","type":"journal-article","created":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T07:20:05Z","timestamp":1620112805000},"page":"1099-1107","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single\u2010Dose, Phase 1 Crossover Trial"],"prefix":"10.1002","volume":"10","author":[{"given":"Ramesh","family":"Boinpally","sequence":"first","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"McNamee","sequence":"additional","affiliation":[{"name":"AbbVie  Marlow UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Li","family":"Yao","sequence":"additional","affiliation":[{"name":"AbbVie  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Butler","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danielle","family":"McGeeney","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Borbridge","sequence":"additional","affiliation":[{"name":"AbbVie  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonia","family":"Periclou","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,5,4]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-physiol-030212-183717"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ncl.2019.06.001"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000252808.97649.21"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12878"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13613"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-018-0617-4"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)32504-8"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-019-00665-9"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2019.1618830"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30234-9"},{"issue":"1","key":"e_1_2_11_12_1","first-page":"15","article-title":"Atogepant significantly reduces mean monthly migraine days in the phase 3 trial (ADVANCE) for the prevention of migraine [abstract MTV20\u2010OR\u2010018]","volume":"40","author":"Ailani J","year":"2020","journal-title":"Cephalalgia"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1067\/mcp.2000.111482"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1610"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731-7085(02)00393-X"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.21037\/jtd.2017.05.34"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/43.suppl_2.83"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/0036554021000026963"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.940","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.940","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.940","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T18:23:41Z","timestamp":1693333421000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.940"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,4]]},"references-count":17,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2021,9]]}},"alternative-id":["10.1002\/cpdd.940"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.940","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,5,4]]},"assertion":[{"value":"2020-11-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-03-02","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-05-04","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}