{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,17]],"date-time":"2026-10-17T22:57:49Z","timestamp":1792277869458,"version":"4.4.0"},"reference-count":42,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,4,5]],"date-time":"2021-04-05T00:00:00Z","timestamp":1617580800000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the impact of two calcitonin gene\u2013related peptide (CGRP)\u2010targeted monoclonal antibodies (mAbs), erenumab and galcanezumab, on the pharmacokinetic (PK) profile, safety, and tolerability of ubrogepant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>People taking CGRP\u2010targeted mAbs for migraine prevention sometimes take ubrogepant, an oral small\u2010molecule CGRP receptor antagonist, for acute treatment of breakthrough migraine attacks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>\n                      In this two\u2010arm, multicenter, open\u2010label, phase 1b trial, adults with migraine were randomized to arm 1 (ubrogepant\u00a0\u00b1\u00a0erenumab) or arm 2 (ubrogepant\u00a0\u00b1\u00a0galcanezumab). The PK profile of ubrogepant was characterized for administration before and 4\u00a0days after CGRP\u2010targeted mAb injection. Participants received single\u2010dose ubrogepant 100\u00a0mg on day 1, subcutaneous erenumab 140\u00a0mg (arm 1) or galcanezumab 240\u00a0mg (arm 2) on day 8, and ubrogepant 100\u00a0mg once daily on days 12\u201315. In each study arm, serial blood samples were drawn on days 1 and 12 for measurement of plasma ubrogepant concentrations. The primary outcomes were area under the plasma ubrogepant concentration\u2013time curve (AUC) from time 0 to\n                      <jats:italic>t<\/jats:italic>\n                      \u00a0post\u2010dose (AUC\n                      <jats:sub>0\u2013<\/jats:sub>\n                      <jats:italic>\n                        <jats:sub>t<\/jats:sub>\n                      <\/jats:italic>\n                      ) and from time 0 to infinity (AUC\n                      <jats:sub>0\u2013inf<\/jats:sub>\n                      ), and maximum plasma concentration (\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      ) of ubrogepant when ubrogepant was administered before or after a single dose of erenumab or galcanezumab. Vital signs and laboratory parameters were monitored.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Forty participants enrolled (20 per arm; mean [standard deviation] ages, 32.2 [8.9] and 38.4 [8.8] years; 50% [10\/20] and 60% [12\/20] female in arms 1 and 2, respectively). There were no significant differences in ubrogepant\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      after versus before erenumab administration (geometric least\u2010squares mean [LSM] ratio, 1.04 [90% CI, 0.93\u20131.16]), and no significant differences in AUC\n                      <jats:sub>0\u2013<\/jats:sub>\n                      <jats:italic>\n                        <jats:sub>t<\/jats:sub>\n                      <\/jats:italic>\n                      (1.06 [0.96\u20131.16]) or AUC\n                      <jats:sub>0\u2013inf<\/jats:sub>\n                      (1.05 [0.96\u20131.15]). Similarly, ubrogepant\n                      <jats:italic>C<\/jats:italic>\n                      <jats:sub>max<\/jats:sub>\n                      (1.00 [90% CI, 0.82\u20131.20]), AUC\n                      <jats:sub>0\u2013<\/jats:sub>\n                      <jats:italic>\n                        <jats:sub>t<\/jats:sub>\n                      <\/jats:italic>\n                      (1.05 [0.90\u20131.23]), and AUC\n                      <jats:sub>0\u2013inf<\/jats:sub>\n                      (1.05 [0.90\u20131.22]) geometric LSM ratios were statistically equivalent after galcanezumab versus ubrogepant alone. Treatment\u2010emergent adverse events (TEAEs) were similar to those reported with each treatment alone. No serious TEAEs, TEAEs leading to discontinuation, or clinically relevant changes in laboratory parameters or vital signs were reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The PK profile of ubrogepant was not significantly changed and no safety concerns were identified when ubrogepant was coadministered with erenumab or galcanezumab.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14095","type":"journal-article","created":{"date-parts":[[2021,4,5]],"date-time":"2021-04-05T08:48:52Z","timestamp":1617612532000},"page":"642-652","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":63,"title":["Pharmacokinetics and safety of ubrogepant when coadministered with calcitonin gene\u2012related peptide\u2010targeted monoclonal antibody migraine preventives in participants with migraine: A randomized phase 1b drug\u2013drug interaction study"],"prefix":"10.1111","volume":"61","author":[{"given":"Abhijeet","family":"Jakate","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew M.","family":"Blumenfeld","sequence":"additional","affiliation":[{"name":"Headache Center of Southern California Carlsbad CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Boinpally","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Butler","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Borbridge","sequence":"additional","affiliation":[{"name":"Bioanalysis, Non\u2010clinical and Translational Sciences AbbVie Irvine CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janette","family":"Contreras\u2010De Lama","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"McGeeney","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonia","family":"Periclou","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B.","family":"Lipton","sequence":"additional","affiliation":[{"name":"The Saul R. Korey Department of Neurology, Department of Psychiatry and Behaviorial Sciences, Department of Epidemiology &amp; Population Health Albert Einstein College of Medicine Bronx NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,4,5]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-physiol-030212-183717"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13456"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000252808.97649.21"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2008.01217.x"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ncl.2019.06.001"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001256"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S3497"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-018-0617-4"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-018-0003-1"},{"key":"e_1_2_11_12_1","unstructured":"Emgality[package 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