{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T18:58:23Z","timestamp":1789844303807,"version":"4.0.1"},"reference-count":17,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T00:00:00Z","timestamp":1676851200000},"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":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Rimegepant is an oral small\u2010molecule calcitonin gene\u2010related peptide antagonist for acute migraine treatment with or without aura and prevention of episodic migraine in adults. This was a rimegepant single\u2010 and multiple\u2010dose phase 1, randomized, placebo\u2010controlled, double\u2010blind study to evaluate the pharmacokinetics and confirm safety in healthy Chinese participants. Participants received a 75\u2010mg rimegepant orally disintegrating tablet (ODT) (N\u00a0=\u00a012) or matching placebo (N\u00a0=\u00a04) ODT on days 1 and 3\u20137 after fasting for pharmacokinetic assessments. Safety assessments included 12\u2010lead electrocardiograms, vital signs, clinical laboratory data, and adverse events (AEs). After a single dose (9 females, 7 males) median time to maximum plasma concentration was 1.5\u00a0hours; mean values were 937\u00a0ng\/mL (maximum concentration), 4582\u00a0h*ng\/mL (area under the concentration\u2013time curve, 0 to infinity), 7.7\u00a0hours (terminal elimination half\u2010life), and 19.9\u00a0L\/h (apparent clearance). Similar results were seen after 5 daily doses, with minimal accumulation. Six (37.5%) participants experienced \u22651 treatment\u2010emergent AE: 4 (33.3%) had received rimegepant and 2 (50.0%) had received placebo. All AEs were grade 1 and resolved by the end of the study with no deaths, serious\/significant AEs, or AEs leading to discontinuation. Overall, single\u2010 and multiple\u2010dose rimegepant ODT 75\u00a0mg was safe and well\u2010tolerated in healthy Chinese adults with similar pharmacokinetics to non\u2010Asian healthy participants.<\/jats:p><jats:p><jats:bold>Trial registration<\/jats:bold>: This trial is registered with the China Center for Drug Evaluation (CDE): CTR20210569<\/jats:p>","DOI":"10.1002\/cpdd.1230","type":"journal-article","created":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T12:41:46Z","timestamp":1676896906000},"page":"594-601","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Pharmacokinetics and Safety of Single and Multiple Daily Dosing of 75\u2010mg\u00a0Rimegepant Orally Disintegrating Tablets in Healthy Chinese Adults: A Randomized Placebo\u2010Controlled Trial"],"prefix":"10.1002","volume":"12","author":[{"given":"Yan","family":"Li","sequence":"first","affiliation":[{"name":"Beijing Shijitan Hospital Affiliated to Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinghe","family":"Wang","sequence":"additional","affiliation":[{"name":"Beijing Shijitan Hospital Affiliated to Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Ballesteros\u2010Perez","sequence":"additional","affiliation":[{"name":"Certara USA  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Bertz","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals Inc.  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhihong","family":"Lu","sequence":"additional","affiliation":[{"name":"Bioshin Limited  Pudong New District Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,2,20]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2011.02061.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13529"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/14728222.2020.1724285"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413500727"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31606-X"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1811090"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32544-7"},{"key":"e_1_2_8_10_1","first-page":"177","article-title":"The pharmacokinetics, safety, and tolerability of rimegepant 75\u00a0mg are similar in elderly and nonelderly adults: a phase 1, open\u2010label, parallel\u2010group, single\u2010dose study","volume":"59","author":"Croop R","year":"2019","journal-title":"Headache"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1088"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1089\/bfm.2021.0250"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/25158163211007922"},{"key":"e_1_2_8_14_1","first-page":"142","article-title":"A Phase 1 study to evaluate the bioequivalence of oral table and orally dissolving tablet formulations of rimegepant, a small molecule CGRP receptor antagonist","volume":"38","author":"Croop R","year":"2018","journal-title":"Cephalalgia"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/1060028020954800"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.9b01810"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-1062-4"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-021-01362-z"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1230","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1230","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1230","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T17:57:50Z","timestamp":1692467870000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1230"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,20]]},"references-count":17,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,6]]}},"alternative-id":["10.1002\/cpdd.1230"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1230","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,20]]},"assertion":[{"value":"2022-10-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-01-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-02-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}