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A randomized, crossover, placebo- and moxifloxacin-controlled study to evaluate the effects of bosutinib (SKI-606), a dual Src/Abl tyrosine kinase inhibitor, on cardiac repolarization in healthy adult subjects.
Author: AbbasRichat, HugBruce A, LeisterCathie, SonnichsenDaryl
Original Abstract of the Article :
Effects of therapeutic and supratherapeutic concentrations of bosutinib, a dual Src/Abl tyrosine kinase inhibitor, on the corrected QT interval (QTc) in 60 healthy adults were assessed, according to ICH-E14 guidelines, in this 2-part, randomized, single-dose, double-blind, crossover, placebo- and op...See full text at original site
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引用元:
https://doi.org/10.1002/ijc.27348
データ提供:米国国立医学図書館(NLM)
Bosutinib and Cardiac Repolarization: A Safety Evaluation in Healthy Adults
The development of new drugs requires rigorous safety evaluation, particularly when it comes to potential effects on the cardiovascular system. This study focuses on bosutinib, a dual Src/Abl tyrosine kinase inhibitor, and its impact on cardiac repolarization, a crucial process for normal heart function. The researchers conducted a randomized, crossover, placebo- and moxifloxacin-controlled study to evaluate the effects of bosutinib on the corrected QT interval (QTc), a measure of cardiac repolarization, in healthy adult subjects.
Bosutinib and QTc Prolongation: No Evidence of Clinically Significant Effects
The study's findings demonstrate that therapeutic and supratherapeutic doses of bosutinib do not appear to be associated with clinically significant QTc prolongation in healthy adults. These results provide reassurance regarding the safety profile of bosutinib in relation to cardiac repolarization. However, it is essential to note that this study was conducted in healthy individuals, and further research is needed to evaluate the potential cardiac effects of bosutinib in patients with pre-existing cardiovascular conditions.
Drug Safety: A Continuous Quest for Understanding
The study's findings highlight the importance of comprehensive safety evaluations for new drugs. It underscores the need for meticulous research to understand potential cardiovascular effects and to ensure that new therapies are safe for use in diverse patient populations. The search for safe and effective treatments is an ongoing journey, requiring ongoing vigilance and commitment to research.
Dr. Camel's Conclusion
This study is like a camel caravan carefully traversing a desert, meticulously checking for signs of danger before proceeding. The researchers have carefully examined the potential impact of bosutinib on cardiac repolarization, providing valuable insights into its safety profile. However, as with any journey, there are always new challenges to face, and the quest for safe and effective treatments for various conditions is a continuous endeavor.
Date :
- Date Completed 2012-07-30
- Date Revised 2018-12-01
Further Info :
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