QT study of Iptakalim Hydrochloride with recommended and supra-therapeutic dose
Purpose:The objective of our study was to determine the QTc effects of iptakalim hydrochloride(ITKL).Methods:A crossover-design thorough QT study of recommended(10 mg once daily,4 days)and supra-therapeutic(20 mg once daily,4 days)doses of ITKL,moxifloxacin(400 mg once daily,4 days),and placebo was performed.Electrocardiograms(ECGs)and pharmacokinetic samples were obtained on days 1-4; time-matched baseline ECGs were taken on day 0.The primary end point was the mean placebo-subtracted change from baseline Fridericia-corrected QT(QTcF)during peak drug exposure on day 4.Findings:Mean QTcF prolongation of moxifloxacin was 12.84 ms(machine-read)and 14.21 ms(manual-read).At recommended and supra-therapeutic iptakalim doses,mean QTcF prolongation was 2.55 and 1.55 ms(machine-read),respectively,and4.17 and 7.16(manual-read),respectively.The QTc effect of iptakalim was lower than that of moxifloxacin.No subject receiving iptakalim exceeded the clinically relevant thresholds of 500 ms absolute QTc or 60 ms change from baseline.Implications:In conclusion,iptakalim does not have a clinically significant effect on QT interval.
iptakalim QT interval hypertension tolterodine
Bai Nan Wang Jin Wen Ke Mei Hekun Tang Mingjing Liang Beibei Wang Rui
Medicine Clinical Research Center,Chinese People”s Liberation Army General Hospital,Beijing,100853,China
国内会议
西安
英文
1-9
2017-11-04（万方平台首次上网日期，不代表论文的发表时间）