{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T21:57:56Z","timestamp":1789595876961,"version":"build-2803163510"},"reference-count":38,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,5,4]],"date-time":"2023-05-04T00:00:00Z","timestamp":1683158400000},"content-version":"vor","delay-in-days":3,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the effect of single and multiple doses of rimegepant 75\u2009mg dose on the pharmacokinetics of an oral contraceptive containing ethinyl estradiol (EE)\/norgestimate (NGM) in healthy females of childbearing potential or non\u2010menopausal females with tubal ligation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Females of childbearing age experience the highest prevalence of migraine and frequently inquire about the concomitant use of anti\u2010migraine medications and contraceptives. Rimegepant, a calcitonin gene\u2013related peptide receptor antagonist, demonstrated efficacy and safety for treating an acute migraine attack and preventing migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This open\u2010label, single\u2010center, phase 1, drug\u2013drug interaction study explored the effects of rimegepant 75\u2009mg daily dose on the pharmacokinetics of an oral contraceptive containing EE\/NGM 0.035\u2009mg\/0.25\u2009mg in healthy females of childbearing potential or non\u2010menopausal females with tubal ligation. During cycles 1 and 2, participants received EE\/NGM once daily for 21\u2009days followed by placebo tablets with inactive ingredients for 7\u2009days. Rimegepant was administered during only cycle 2 for 8\u2009days, from days 12 through 19. The primary endpoint was the effect of single and multiple doses of rimegepant on the pharmacokinetics of EE and norelgestromin (NGMN), an active metabolite of NGM, at steady state, including area under the concentration\u2010time curve for 1 dosing interval (AUC\n                      <jats:sub>\n                        0\u2212\n                        <jats:italic>\u03c4<\/jats:italic>\n                        ,ss\n                      <\/jats:sub>\n                      ) and maximum observed concentration (\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>ss[max]<\/jats:sub>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The study enrolled 25 participants, with pharmacokinetic data assessed for 20 participants. A single 75\u2009mg dose of rimegepant co\u2010administered with EE\/NGM increased exposures of EE and NGMN by \u226416% (geometric mean ratio [GMR], 1.03; 90% confidence interval [CI], 1.01\u20131.06; and GMR, 1.16; 90% CI, 1.13\u20131.20, respectively). After 8\u2009days of co\u2010administering EE\/NGM with rimegepant, EE pharmacokinetic parameters, AUC\n                      <jats:sub>\n                        0\u2212\n                        <jats:italic>\u03c4<\/jats:italic>\n                        ,ss\n                      <\/jats:sub>\n                      and\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>ss(max)<\/jats:sub>\n                      , increased by 20% (GMR, 1.20; 90% CI, 1.16\u20131.25) and 34% (GMR, 1.34; 90% CI, 1.23\u20131.46), respectively, and NGMN pharmacokinetic parameters increased by 46% (GMR, 1.46; 90% CI, 1.39\u20131.52) and 40% (GMR, 1.40; 90% CI, 1.30\u20131.51), respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The study identified modest elevations in overall EE and NGMN exposures after multiple doses of rimegepant, but these elevations are unlikely to be clinically relevant in healthy females with migraine.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14512","type":"journal-article","created":{"date-parts":[[2023,5,4]],"date-time":"2023-05-04T07:29:50Z","timestamp":1683185390000},"page":"652-662","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Effects of rimegepant 75\u2009mg daily on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate in healthy female participants"],"prefix":"10.1111","volume":"63","author":[{"given":"Rajinder","family":"Bhardwaj","sequence":"first","affiliation":[{"name":"Certara USA  Princeton New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph C.","family":"Stringfellow","sequence":"additional","affiliation":[{"name":"Navitas Data Sciences  Pottstown Pennsylvania 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