{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,7,4]],"date-time":"2024-07-04T02:41:30Z","timestamp":1720060890850},"reference-count":24,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,5,17]],"date-time":"2024-05-17T00:00:00Z","timestamp":1715904000000},"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":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Cofrogliptin (HSK7653) is a long\u2010acting dipeptidyl peptidase\u20104 inhibitor for the treatment of type 2 diabetes mellitus with a twice\u2010monthly dosing regimen. This study included 62 participants (48 without food effect, 14 with food effect) receiving single doses of HSK7653 (5, 10, 25, 50, 100, and 150\u00a0mg) or placebo. Pharmacokinetic samples were collected over 24\u00a0hours postdosing and sampling times are aligned with 12\u2010lead electrocardiograms (ECGs) which were derived from continuous ECG recordings. For the concentration\u2010QT interval corrected for heart rate (C\u2010QTc) analysis, we used linear mixed\u2010effects modeling to characterize the correlation between plasma concentrations of HSK7653 and the change from baseline in the QT interval which was corrected by Fridericia's formula (\u0394QTcF). The result showed that a placebo\u2010corrected Fridericia corrected QT interval (\u0394\u0394QTcF) prolongation higher than 10\u00a0milliseconds is unlikely at the mean maximum observed concentration (C<jats:sub>max<\/jats:sub>) (411\u00a0ng\/mL) associated with the recommended therapeutic doses (25\u00a0mg twice\u2010monthly), even at the highest supratherapeutic concentration (2425\u00a0ng\/mL). Thus, HSK7653 does not significantly affect QT prolongation at either recommended doses or the highest supratherapeutic concentration.<\/jats:p>","DOI":"10.1002\/cpdd.1418","type":"journal-article","created":{"date-parts":[[2024,5,17]],"date-time":"2024-05-17T07:35:47Z","timestamp":1715931347000},"page":"716-728","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Concentration\u2010QTc Modeling of the DPP\u20104 Inhibitor HSK7653 in a First\u2010in\u2010Human Study of Chinese Healthy Volunteers"],"prefix":"10.1002","volume":"13","author":[{"given":"Xiaoxu","family":"Wang","sequence":"first","affiliation":[{"name":"Drug Clinical Trial Center Peking University Third Hospital  Beijing China"},{"name":"Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Science  Tianjin China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hongzhong","family":"Liu","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Research Center Peking Union Medical College Hospital and Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng","family":"Cui","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center Peking University Third Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoye","family":"Niu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center Peking University Third Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haiyan","family":"Li","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center Peking University Third Hospital  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shu","family":"Niu","sequence":"additional","affiliation":[{"name":"Drug Clinical Trial Center Peking University Third Hospital  Beijing China"},{"name":"Department of Pharmaceutical Outcomes &amp; Policy College of Pharmacy University of Florida FL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pangke","family":"Yan","sequence":"additional","affiliation":[{"name":"Haisco Pharmaceutical Group Co. 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