{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T16:08:05Z","timestamp":1769098085111,"version":"3.49.0"},"reference-count":32,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,5,3]],"date-time":"2024-05-03T00:00:00Z","timestamp":1714694400000},"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":[[2024,8]]},"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. Atogepant is a substrate of P\u2010glycoprotein (P\u2010gp), breast cancer resistance protein, organic anion transporting polypeptide transporters, and cytochrome P450 (CYP)3A4 and 2D6. Quinidine is a strong P\u2010gp and CYP2D6 inhibitor. A phase 1 open\u2010label study evaluated the effect of P\u2010gp and CYP2D6 inhibition by quinidine on the pharmacokinetics of atogepant, and the safety and tolerability of atogepant and quinidine gluconate (QG) when co\u2010administered and when given alone in 33 healthy adults. There was no significant change in the atogepant maximum plasma concentration with QG co\u2010administration. The overall systemic exposure, the area under the plasma concentration\u2010time curve (from time 0 to time t or to infinity), of atogepant increased by 25% when co\u2010administered with QG. However, such an increase was not considered clinically relevant. Atogepant did not alter the mean plasma concentration of quinidine at steady state. The incidence of treatment\u2010emergent adverse events (TEAEs) was highest when QG was administered alone (42.4%), which was primarily due to QT prolongation. Most TEAEs reported were mild in severity and resolved within 1\u20102 days. Co\u2010administration of atogepant with QG did not result in any unexpected tolerability findings in this phase 1 study in healthy participants. The increase in atogepant exposure during QG co\u2010administration could be due to inhibition of CYP2D6 (a minor contributor to atogepant clearance) as well as inhibition of P\u2010gp.<\/jats:p>","DOI":"10.1002\/cpdd.1407","type":"journal-article","created":{"date-parts":[[2024,5,4]],"date-time":"2024-05-04T06:29:45Z","timestamp":1714804185000},"page":"930-937","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Pharmacokinetics and Safety of Atogepant Co\u2010administered with Quinidine Gluconate in Healthy Participants: A Phase 1, Open\u2010Label, Drug\u2010Drug Interaction Study"],"prefix":"10.1002","volume":"13","author":[{"given":"Ramesh","family":"Boinpally","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie  North Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Borbridge","sequence":"additional","affiliation":[{"name":"Bioanalysis AbbVie  Irvine CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronica","family":"Wangsadipura","sequence":"additional","affiliation":[{"name":"Data and Statistical Sciences AbbVie  Irvine CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,5,3]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-021-00509-5"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32160-7"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-022-01402-2"},{"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","doi-asserted-by":"publisher","DOI":"10.1111\/head.14135"},{"key":"e_1_2_10_9_1","doi-asserted-by":"crossref","DOI":"10.1177\/25158163231191582","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_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13707"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2217\/pmt\u20102023\u20100056"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-021-01034-5"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1610"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14433"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.2217\/pmt-2023-0040"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.2217\/pmt-2021-0073"},{"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":"10.1124\/dmd.31.3.289"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/00912709922008173"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1021\/js980197h"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-198005020-00003"},{"issue":"2","key":"e_1_2_10_22_1","first-page":"365","article-title":"Pharmacokinetics of quinidine in humans after intravenous, intramuscular and oral administration","volume":"202","author":"Greenblatt DJ","year":"1977","journal-title":"J Pharmacol Exp Ther"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9149(78)90830-5"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-014-2438-4"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1267"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00432-022-04387-2"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10928-023-09867-7"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.99.4.552"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002800050258"},{"key":"e_1_2_10_30_1","doi-asserted-by":"crossref","unstructured":"RoweJ ChanH ChandrasekarP RojoJ BoinpallyR.Mass Balance and Metabolism of Carbon\u201014 Atogepant in Healthy Male Participants [abstract]. 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