{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T00:47:42Z","timestamp":1787014062825,"version":"build-2736575974"},"reference-count":14,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,6,18]],"date-time":"2025-06-18T00:00:00Z","timestamp":1750204800000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    This Phase 1, non\u2010randomized, open\u2010label, 2\u2010period study compared the pharmacokinetics (PK) of zavegepant nasal spray, using samples collected via patient\u2010centric microsampling (PCS) devices, with those collected through venous phlebotomy (NCT05948085). Fourteen healthy participants received a single intranasal dose of 10\u2009mg zavegepant on Days 1 and 2. Blood samples for PK analysis were collected at 0.5, 1, 2, 4, 8, and 12\u2009h post dose on Day 1 using the Tasso\u2010Plus device (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20097; produces serum samples), Tasso\u2010M20 (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20097; produces dried blood samples), and venous phlebotomy (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200914). PK parameters were calculated using non\u2010compartmental methods. Natural log\u2010transformed areas under the plasma\/serum concentration\u2010time profile from time zero to the time of the last quantifiable concentration (AUC\n                    <jats:sub>last<\/jats:sub>\n                    ) and maximum serum\/plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) of zavegepant were analyzed using a mixed\u2010effects model, with blood collection as a fixed effect and participant as a random effect. Of the two PCS devices assessed, the results of the Tasso\u2010Plus device showed successful bridging with venous phlebotomy sampling. For Tasso\u2010Plus versus venous phlebotomy, 39 of 41 (95.1%) data pairs met concentration correlation criteria (difference within 20% of the mean), median zavegepant concentration\u2010time profiles were comparable, and 90% confidence intervals for geometric mean ratios for AUC\n                    <jats:sub>last<\/jats:sub>\n                    and C\n                    <jats:sub>max<\/jats:sub>\n                    were wholly within the range of bioequivalence acceptance (80%\u2013125%). The results of this study confirm that it is feasible to use serum derived from Tasso\u2010Plus collection of whole capillary blood as a reliable PCS approach for PK analysis of zavegepant.\n                  <\/jats:p>","DOI":"10.1111\/cts.70199","type":"journal-article","created":{"date-parts":[[2025,6,18]],"date-time":"2025-06-18T05:44:54Z","timestamp":1750225494000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A Pharmacokinetic Study of Zavegepant Nasal Spray in Healthy Adults Comparing Conventional Venous Blood Sampling With Patient\u2010Centric Microsampling"],"prefix":"10.1111","volume":"18","author":[{"given":"Mohamed H.","family":"Shahin","sequence":"first","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ogert","family":"Fisniku","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Lake Forest Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ding","family":"Ding","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katty","family":"Wan","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergey","family":"Dubrovin","sequence":"additional","affiliation":[{"name":"Pfizer  Moscow Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyle","family":"Matschke","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Kavetska","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4105-1248","authenticated-orcid":false,"given":"Robert","family":"Fountaine","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Liu","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,18]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"Zavegepant Prescribing Information https:\/\/labeling.pfizer.com\/ShowLabeling.aspx?id=19471."},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(22)00517-8"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14389"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/03331024241259456"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13220"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2017.11.005"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13411"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-020-00524-2"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.3390\/jpm12020231"},{"key":"e_1_2_10_11_1","first-page":"20","article-title":"Do\u2010It\u2010Yourself Blood Sampling for Pediatric Clinical Trials: Evaluating Efforts to Obtain Youth and Parent Perspectives on the Concept of Microsampling in Pediatric Clinical Trials","volume":"29","author":"Wickremsinhe E.","year":"2020","journal-title":"Applied Clinical Trials"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.3025"},{"key":"e_1_2_10_13_1","unstructured":"Tasso \u201cFrequently Asked Questions.\u201dhttps:\/\/www.tassoinc.com\/faq."},{"key":"e_1_2_10_14_1","first-page":"825","article-title":"Patient\u2010Centric Microsampling for Abrocitinib Pharmacokinetics: Multiple\u2010Analytes Assay Bridging Using Tasso Device","volume":"16","author":"Tripathy S.","year":"2024","journal-title":"Bioanalysis"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.job.2021.08.006"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70199","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T09:36:45Z","timestamp":1750930605000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.70199"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6]]},"references-count":14,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1111\/cts.70199"],"URL":"https:\/\/doi.org\/10.1111\/cts.70199","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6]]},"assertion":[{"value":"2024-12-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-28","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-18","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70199"}}