Thorough QT Study with Recommended and Supratherapeutic Doses of Iptakalim hydrochloride
The objective of our study was to determine the QTc effects of Iptakalim hydrochloride (ITKL).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.Mean placebo-subtracted change from baseline Fridericia-corrected QT (QTcF) during peak drug exposure on day 4 was the primary end point.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 ms (machine-read), respectively, and4.17 and 7.16 (manual-read), respectively.The QTc effect of Iptakalim was lower than moxifloxacin.No subject receiving Iptakalim exceeded the clinically relevant thresholds of 500 ms absolute QTc or 60 ms change from baseline.In conclusion,Iptakalim does not have a clinically significant effect on QT interval.
Bai Nan Wang Jin Wen Ke Mei Hekun Tang Mingjing Liang Beibei Zhang Lei Liu Youning Wang Rui
Medicine Clinical Research Center, Chinese People” s Liberation Army General Hospital, Beijing ,100853, China
国内会议
杭州
英文
177-197
2015-07-01（万方平台首次上网日期，不代表论文的发表时间）