title: [Effect of single doses of HX0507 on QTc intervals in healthy people: a phase I safety and tolerability study].
abstract: OBJECTIVE
  To assess the effect of HX0507 on QTc interval in healthy people in a phase I safety and tolerability study.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Single administration of HX0507 induces dose-related QT prolongation.
authors: Laboratory of Anesthesia and Critical Care Medicine, Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu 610041, China.
authors: Xiao-Qian
authors: XQ
authors: Yi
authors: Rui
authors: R
authors: Li
authors: Wen-Sheng
authors: WS
authors: Zhang
authors: Jin
authors: J
authors: Liu
authors: Jing
authors: J
authors: Xu
authors: Tian-Zhi
authors: TZ
authors: Liao
mesh_terms: D000293:Adolescent; D000328:Adult; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D011355:Prodrugs / Q000009:adverse effects* / Q000494:pharmacology*; D015742:Propofol / Q000009:adverse effects* / Q000031:analogs & derivatives / Q000494:pharmacology*; D055815:Young Adult
chemical_list: C000604338:HX0507; D011355:Prodrugs; D015742:Propofol