{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T17:49:59Z","timestamp":1792172999567,"version":"4.4.0"},"reference-count":45,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Carbetocin is an oxytocin receptor agonist used for postpartum hemorrhage prevention. While oxytocin is known to transiently prolong the QT\/QTc interval, robust QTc data for carbetocin are limited. Carbetocin is known to elevate HR, which can impact QTc analyses; thus, a dose that did not overly elevate HR was important to select. This randomized, placebo\u2010 and positive\u2010controlled trial evaluated the effect of a single intravenous infusion of a supratherapeutic dose (650\u2009\u03bcg) of carbetocin over 45\u2009min on cardiac repolarization in healthy adults (\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200942). Continuous cardiodynamic ECGs were recorded from 45\u2009min before through 24\u2009h after dosing. The primary endpoint was placebo\u2010corrected change from baseline in QT interval (\u0394\u0394QTc) using the most appropriate heart rate (HR) correction method. The primary analysis was based on exposure\u2010response modeling of the relationship between carbetocin plasma concentrations and \u0394\u0394QTc, to identify an effect \u2265\u200910\u2009msec at the high clinical exposure. During intravenous infusion of carbetocin, the mean HR change from baseline reached a maximum of 16.7\u2009bpm. Multiple correction methods for HR were assessed, and the placebo\u2010corrected, optimized, individualized heart rate\u2013corrected QT interval (oQTcI) was found to be adequate. The estimated mean placebo\u2010corrected oQTcI change from baseline was 4.5\u2009msec (90% CI: 3.4, 5.6) at the high clinical exposure level of 12.4\u2009ng\/mL following a single intravenous infusion of 867\u2009\u03bcg\/h carbetocin. Exposure\u2010response models for carbetocin established no predicted QTc prolongations of clinical or regulatory concern (\u2265\u200910\u2009msec) at the high clinical exposure level.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                    Registration: NCT05924321\n                  <\/jats:p>","DOI":"10.1111\/cts.70735","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T07:14:23Z","timestamp":1790579663000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Effect of Carbetocin on Cardiac Repolarization: A Randomized, Placebo\u2010 and Positive\u2010Controlled\n                    <scp>QT<\/scp>\n                    \/\n                    <scp>QTc<\/scp>\n                    Study in Healthy Adults"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8227-9361","authenticated-orcid":false,"given":"Dani\u00ebl M.","family":"Jonker","sequence":"first","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8082-1885","authenticated-orcid":false,"given":"Katie","family":"Barletta","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ekaterine","family":"Bagci","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyle","family":"Raymond","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4227-7687","authenticated-orcid":false,"given":"Philippe","family":"Pinton","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals A\/S  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,28]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejogrb.2009.06.018"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD005457.pub4"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1805489"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/anae.14757"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.14116"},{"key":"e_1_2_10_7_1","unstructured":"World Health Organization \u201cA Roadmap to Combat Postpartum Haemorrhage between 2023 and 2030 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