{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T15:49:39Z","timestamp":1781106579199,"version":"3.54.1"},"reference-count":20,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T00:00:00Z","timestamp":1720742400000},"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":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Atogepant, an oral calcitonin gene\u2010related peptide receptor antagonist, is approved for the preventive treatment of migraine. A phase 1, open\u2010label, single\u2010dose, 2\u2010period crossover study evaluated the effect of a high\u2010fat meal on the pharmacokinetics and safety of atogepant in 20 healthy adults. Administration of atogepant 60\u00a0mg immediate\u2010release (IR) tablets under fed conditions reduced the area under the plasma concentration\u2010time curve (AUC) from 0 to time t and from 0 to time infinity by approximately 18% and reduced the maximum plasma concentration (C<jats:sub>max<\/jats:sub>) by 22%. The 90% confidence intervals for the geometric mean ratios of C<jats:sub>max<\/jats:sub> and AUC were not contained within the bioequivalence limits of 80%\u2010125%. There was no change in the median time to maximum plasma concentration in the fed versus fasted state. The incidence of treatment\u2010emergent adverse events (TEAEs) was similar between fed and fasted conditions. Four TEAEs were considered related to study intervention and were reported after participants received atogepant under fasted conditions (3 participants). A single\u2010dose atogepant 60\u00a0mg IR tablet was safe and tolerated under both fed and fasted states. Due to the wide effective dose range of 10\u201060\u00a0mg\/day for atogepant for the preventive treatment of migraine, the food effect on its pharmacokinetics is not considered clinically relevant.<\/jats:p>","DOI":"10.1002\/cpdd.1451","type":"journal-article","created":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T07:53:35Z","timestamp":1720770815000},"page":"1212-1218","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Effect of a High\u2010Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet"],"prefix":"10.1002","volume":"13","author":[{"given":"Ramesh R.","family":"Boinpally","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel M.","family":"Trugman","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,7,12]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32160-7"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-022-01402-2"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-021-00509-5"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30234-9"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2035908"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)01049-8"},{"key":"e_1_2_10_8_1","article-title":"Pharmacokinetic and pharmacodynamic assessments of atogepant in healthy male adults: results from phase 1 studies","volume":"6","author":"Boinpally R","year":"2023","journal-title":"Cephalalgia Rep"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13707"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.2217\/pmt-2023-0056"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1407"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.2217\/pmt-2021-0073"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-021-01034-5"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.2217\/pmt-2023-0040"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14433"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1610"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.916"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1267"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-013-9499-x"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1099-081X(199804)19:3<153::AID-BDD90>3.0.CO;2-T"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13675"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1451","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,5]],"date-time":"2024-11-05T04:25:53Z","timestamp":1730780753000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1451"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,12]]},"references-count":20,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2024,11]]}},"alternative-id":["10.1002\/cpdd.1451"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1451","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,12]]},"assertion":[{"value":"2024-04-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}