{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T16:52:07Z","timestamp":1785775927289,"version":"3.56.0"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,2,14]],"date-time":"2022-02-14T00:00:00Z","timestamp":1644796800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This study aimed to evaluate the QT prolongation potential of domperidone in healthy Chinese participants and explore the possibility of a thorough QT (TQT) study in China with a smaller sample size using concentration\u2010QT (C\u2010QT) modeling. Part 1 was a randomized, placebo\u2010 and positive\u2010controlled, multiple\u2010dose, 4\u2010way crossover TQT study in healthy Chinese participants; 44 participants were randomized to either domperidone 10\/20\u00a0mg or placebo 3 times daily, on days 1 to 3, followed by a single dose of either 10\/20\u00a0mg domperidone\/domperidone\u2010placebo\/domperidone\u2010placebo plus 400\u00a0mg of moxifloxacin, on day 4. Twelve\u2010lead electrocardiograms were recorded in triplicate at predefined time points with pharmacokinetic sampling. The results were that change from baseline in QT interval corrected for heart rate (QTc) using the Fridericia formula (QTcF) between domperidone and placebo was 1.3\u00a0milliseconds and 2.7\u00a0milliseconds for 10 and 20\u00a0mg 3 times daily, and upper limits of 2\u2010sided 90%CI for all time points were below regulatory threshold of 10\u00a0milliseconds. In part 2, resampling analysis using C\u2010QT modeling for moxifloxacin showed false\u2010negative rates of &lt;5% with sample sizes \u22656. We could conclude that no clinically relevant effect on corrected QT interval or new safety signals was observed with domperidone. A dedicated TQT study with C\u2010QT modeling could assess drug effects on QT\/corrected QT intervals for novel drug development in China.<\/jats:p>","DOI":"10.1002\/cpdd.1072","type":"journal-article","created":{"date-parts":[[2022,2,14]],"date-time":"2022-02-14T18:57:24Z","timestamp":1644865044000},"page":"734-743","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Four\u2010Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT\/QTc Study in China"],"prefix":"10.1002","volume":"11","author":[{"given":"Fangfang","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Cardiology and Institute of Vascular Medicine Peking University Third Hospital  Beijing China"},{"name":"NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides Peking University Third Hospital  Beijing China"},{"name":"Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Peking University Third Hospital  Beijing China"},{"name":"Beijing Key Laboratory of Cardiovascular Receptors Research Peking University Third Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Nie","sequence":"additional","affiliation":[{"name":"Janssen China R&amp;D  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Peking University Third Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenhua","family":"Yang","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center Peking University Third Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Xu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center Peking University Third Hospital  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liqun","family":"Wang","sequence":"additional","affiliation":[{"name":"Janssen China R&amp;D  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huimin","family":"Liao","sequence":"additional","affiliation":[{"name":"Janssen China R&amp;D  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mengyu","family":"Li","sequence":"additional","affiliation":[{"name":"OTC Medical Affairs, Xian Janssen Pharmaceutical Ltd.  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