| Autor: |
Xiao-Qian, Yi, Rui, Li, Wen-Sheng, Zhang, Jin, Liu, Jing, Xu, Tian-Zhi, Liao |
| Rok vydání: |
2013 |
| Předmět: |
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| Zdroj: |
Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition. 43(6) |
| ISSN: |
1672-173X |
| Popis: |
To assess the effect of HX0507 on QTc interval in healthy people in a phase I safety and tolerability study.Eighty healthy people were randomly assigned to one of the 13 dosage groups. Standard 12-lead ECGs data were collected before and after HX0507, a water soluble prodrug of propofol, was given intravenously to the participants (at 33 time points). The QT interval values were corrected for heart rate using Fridericia's formula (QTcF = QT/RR(0.33)) and Bazett's formula (QTcB=QT/RR(0.5)). The primary target variable was baseline-adjusted changes in QTcF (deltaQTcF).Prolongation of QT interval was induced by HX0507 administered at an anticipated clinical dosage (3 mg/kg) or at a stronger dosage (8 mg/kg) and above. The mean deltaQTcF ranged from 5.61 ms to 32.24 ms, with an upper limit of 90% CI ranging from 10.30 ms to 53.90 ms. There was a linear correlation between HX0507 dosage and its effect on QT interval. Eight types of ECG-related adverse events were detected in 32 subjects.Single administration of HX0507 induces dose-related QT prolongation. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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