{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T18:19:39Z","timestamp":1788459579086,"version":"build-2803163510"},"reference-count":30,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,3,19]],"date-time":"2022-03-19T00:00:00Z","timestamp":1647648000000},"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":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Rimegepant (Nurtec ODT)\u2014an orally administered, small\u2010molecule calcitonin gene\u2013related peptide receptor antagonist indicated for the acute and preventive treatment of migraine\u2014is a substrate for both the P\u2010glycoprotein and breast cancer resistance protein transporters in vitro. We evaluated the effects of concomitant administration of strong inhibitors of these transporters on the pharmacokinetics of rimegepant in healthy subjects. This single\u2010center, open\u2010label, randomized study was conducted in 2 parts, both of which were 2\u2010period, 2\u2010sequence, crossover studies. Part 1 (n = 15) evaluated the effect of a single oral dose of 200\u2010mg cyclosporine, a strong inhibitor of the P\u2010glycoprotein and breast cancer resistance protein transporters, on the pharmacokinetics of rimegepant 75 mg. Part 2 (n = 12) evaluated the effect of a single oral dose of 600\u2010mg quinidine, a strong selective P\u2010glycoprotein transporter, on the pharmacokinetics of rimegepant 75 mg. Coadministration with cyclosporine showed an increase in rimegepant area under the plasma concentration\u2013time curve from time 0 to infinity and maximum observed concentration based on geometric mean ratios (90% confidence intervals [CIs]) of 1.6 (1.49\u20101.72) and 1.41 (1.27\u20101.57), respectively, versus rimegepant alone. Coadministration with quinidine showed an increase in rimegepant area under the plasma concentration\u2013time curve from time 0 to infinity and maximum observed concentration geometric mean ratios (90% CIs) of 1.55 (1.40\u20101.72) and 1.67 (1.46\u20101.91), respectively, versus rimegepant alone. Strong P\u2010glycoprotein inhibitors (cyclosporine, quinidine) increased rimegepant exposures (&gt;50%, &lt;2\u2010fold). In parts 1 and 2, rimegepant coadministration was well tolerated and safe. The similar effect of cyclosporine and quinidine coadministration on rimegepant exposure suggests that inhibition of breast cancer resistance protein inhibition may have less influence on rimegepant exposure.<\/jats:p>","DOI":"10.1002\/cpdd.1088","type":"journal-article","created":{"date-parts":[[2022,3,19]],"date-time":"2022-03-19T12:05:33Z","timestamp":1647691533000},"page":"889-897","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["P\u2010Glycoprotein and Breast Cancer Resistance Protein Transporter Inhibition by Cyclosporine and Quinidine on the Pharmacokinetics of Oral Rimegepant in Healthy Subjects"],"prefix":"10.1002","volume":"11","author":[{"given":"Rajinder","family":"Bhardwaj","sequence":"first","affiliation":[{"name":"Certara USA  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie L.","family":"Collins","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Stringfellow","sequence":"additional","affiliation":[{"name":"Navitas Data Sciences  Pottstown Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Madonia","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt S.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Certara USA  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeri\u2010anne","family":"Finley","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Stock","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladimir","family":"Coric","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Croop","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Bertz","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,3,19]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14153"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-1010-3"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12864"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics12050417"},{"key":"e_1_2_9_7_1","unstructured":"PubChem [Internet]. Bethesda (MD): National Library of Medicine (US) National Center for Biotechnology Information; 2004\u2010. PubChem Compound Summary for CID 51049968 Rimegepant.https:\/\/pubchem.ncbi.nlm.nih.gov\/compound\/Rimegepant. Accessed January 21 2022."},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.9b01810"},{"key":"e_1_2_9_9_1","first-page":"1336","article-title":"Efficacy, safety, and tolerability of rimegepant 75 mg, an oral CGRP receptor antagonist, for the acute treatment of migraine: results from a double\u2010blind, randomized, placebo\u2010controlled trial, study 301","volume":"58","author":"Lipton R","year":"2018","journal-title":"Headache"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1811090"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31606-X"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32544-7"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000008944"},{"issue":"1","key":"e_1_2_9_14_1","first-page":"1","article-title":"Long\u2010term, open\u2010label safety study of rimegepant 75 mg for the treatment of migraine (study 201): interim analysis of safety and exploratory efficacy (IHC\u2010PO\u2010127)","volume":"39","author":"Lipton RB","year":"2019","journal-title":"Cephalalgia"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/1060028020954800"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2021.1895749"},{"key":"e_1_2_9_17_1","unstructured":"US Food and Drug Administration. Drug Approval Package: NURTEC ODT. 2020.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/212728s012lbl.pdf. Accessed March 12 2022."},{"key":"e_1_2_9_18_1","first-page":"1287","article-title":"A phase 1 study to evaluate the bioequivalence of oral tablet and orally dissolving tablet formulations of rimegepant in healthy adult subjects under fasting conditions","volume":"58","author":"Croop R","year":"2018","journal-title":"Headache"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12343"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12075"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02931-15"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.102.037549"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.2967\/jnumed.108.059162"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2010.11"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.613"},{"issue":"1","key":"e_1_2_9_26_1","first-page":"26","article-title":"Sheehan Suicidality Tracking Scale (Sheehan\u2010STS): preliminary results from a multicenter clinical trial in generalized anxiety disorder","volume":"6","author":"Coric V","year":"2009","journal-title":"Psychiatry (Edgmont)"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.02.058"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413500727"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1186\/1129-2377-14-S1-P118"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.130"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1988.tb03400.x"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1088","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.1088","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1088","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T05:56:56Z","timestamp":1692856616000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1088"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,19]]},"references-count":30,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["10.1002\/cpdd.1088"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1088","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,3,19]]},"assertion":[{"value":"2021-10-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-02-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}