{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T18:30:16Z","timestamp":1789065016497,"version":"build-2803163510"},"reference-count":10,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,7,11]],"date-time":"2024-07-11T00:00:00Z","timestamp":1720656000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Avacopan 30\u00a0mg twice daily (BID) is approved for the treatment of severe active antineutrophil cytoplasmic autoantibody\u2013associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis). Food effect on avacopan pharmacokinetics (PKs) and PK bridging in Japanese participants were examined through 2 phase 1 studies involving healthy adult participants. In Study 1, an open\u2010label, crossover trial, participants received oral administration of a single 30\u2010mg dose of avacopan under fasted and fed conditions. Study 2 was a randomized, single\u2010blind, placebo\u2010controlled trial in Caucasian and Japanese participants: Part A investigated single doses of 10 and 30\u00a0mg of avacopan under fasted and fed conditions and Part B investigated 30 and 50\u00a0mg BID avacopan. The PKs of single\u2010dose administrations of 10 and 30\u00a0mg in Japanese participants was compared with that in Caucasian participants under fasted conditions. Food substantially increased plasma avacopan area under the plasma concentration\u2010time curve from time 0 to time infinity (AUC<jats:sub>0\u2010inf<\/jats:sub>) by 1.72\u2010fold, supporting the recommendation of taking avacopan with food. Maximum plasma concentration (C<jats:sub>max<\/jats:sub>) remained relatively unchanged. The median time to reach C<jats:sub>max<\/jats:sub> (t<jats:sub>max<\/jats:sub>) was delayed by 3\u00a0hours. No significant food effect was observed on the active metabolite CCX168\u2010M1 (M1) AUC. Avacopan and M1 exposures were &lt;1.5\u2010fold higher in Japanese participants than in Caucasian participants following multiple\u2010dose administration of avacopan.<\/jats:p>","DOI":"10.1002\/cpdd.1436","type":"journal-article","created":{"date-parts":[[2024,7,12]],"date-time":"2024-07-12T06:43:17Z","timestamp":1720766597000},"page":"1011-1023","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Food Effect and Pharmacokinetic Bridging of Avacopan in Caucasian and Japanese Healthy Participants"],"prefix":"10.1002","volume":"13","author":[{"given":"Shichang","family":"Miao","sequence":"first","affiliation":[{"name":"Amgen Inc.  Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pirow","family":"Bekker","sequence":"additional","affiliation":[{"name":"Amgen Inc.  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Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashit","family":"Trivedi","sequence":"additional","affiliation":[{"name":"Amgen Inc.  Thousand Oaks CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,7,11]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2016111179"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-021-01643-6"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1389"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0164646"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2023386"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2022.09.009"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics12070672"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0832-z"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-199937030-00003"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.04.003"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1436","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,9,2]],"date-time":"2024-09-02T01:56:04Z","timestamp":1725242164000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1436"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,11]]},"references-count":10,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["10.1002\/cpdd.1436"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1436","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,11]]},"assertion":[{"value":"2024-02-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}