دورية أكاديمية
Concentration-QTc Modeling of the DPP-4 Inhibitor HSK7653 in a First-in-Human Study of Chinese Healthy Volunteers.
| العنوان: | Concentration-QTc Modeling of the DPP-4 Inhibitor HSK7653 in a First-in-Human Study of Chinese Healthy Volunteers. |
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| المؤلفون: | Wang X; Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China.; Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Science, Tianjin, China., Liu H; Clinical Pharmacology Research Center, Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, Beijing, China., Cui C; Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China., Niu X; Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China., Li H; Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China., Niu S; Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China.; Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Florida, FL, USA., Yan P; Haisco Pharmaceutical Group Co. Ltd., Chengdu, China., Wu N; Haisco Pharmaceutical Group Co. Ltd., Chengdu, China., Li F; Haisco Pharmaceutical Group Co. Ltd., Chengdu, China., Wu Q; Haisco Pharmaceutical Group Co. Ltd., Chengdu, China., Chen K; Haisco Pharmaceutical Group Co. Ltd., Chengdu, China., Hu B; Clinical Pharmacology Research Center, Peking Union Medical College Hospital and Chinese Academy of Medical Sciences, Beijing, China., Liu D; Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China. |
| المصدر: | Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2024 Jul; Vol. 13 (7), pp. 716-728. Date of Electronic Publication: 2024 May 17. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley Country of Publication: United States NLM ID: 101572899 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2160-7648 (Electronic) Linking ISSN: 2160763X NLM ISO Abbreviation: Clin Pharmacol Drug Dev Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2013- : Hoboken, NJ : Wiley Original Publication: Thousand Oaks, Calif. : Sage Publications, c2012- |
| مواضيع طبية MeSH: | Dipeptidyl-Peptidase IV Inhibitors*/pharmacokinetics , Dipeptidyl-Peptidase IV Inhibitors*/administration & dosage , Dipeptidyl-Peptidase IV Inhibitors*/adverse effects , Dose-Response Relationship, Drug* , Electrocardiography*/drug effects , Healthy Volunteers* , Heart Rate*/drug effects, Adult ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Double-Blind Method ; Long QT Syndrome/chemically induced ; East Asian People |
| مستخلص: | Cofrogliptin (HSK7653) is a long-acting dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus with a twice-monthly 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 mg) or placebo. Pharmacokinetic samples were collected over 24 hours postdosing and sampling times are aligned with 12-lead electrocardiograms (ECGs) which were derived from continuous ECG recordings. For the concentration-QT interval corrected for heart rate (C-QTc) analysis, we used linear mixed-effects 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 (ΔQTcF). The result showed that a placebo-corrected Fridericia corrected QT interval (ΔΔQTcF) prolongation higher than 10 milliseconds is unlikely at the mean maximum observed concentration (C (© 2024, The American College of Clinical Pharmacology.) |
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| فهرسة مساهمة: | Keywords: Chinese healthy subjects; C‐QTc modeling and simulation; HSK7653; QTc interval prolongation |
| المشرفين على المادة: | 0 (Dipeptidyl-Peptidase IV Inhibitors) |
| تواريخ الأحداث: | Date Created: 20240517 Date Completed: 20240703 Latest Revision: 20240705 |
| رمز التحديث: | 20240706 |
| DOI: | 10.1002/cpdd.1418 |
| PMID: | 38757550 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2160-7648 |
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| DOI: | 10.1002/cpdd.1418 |