ICON plc’s clinical research unit in San Antonio is now a certified site in iCardiac’s Early Precision QT Program, which enables ICON to offer iCardiac’s services for evaluating the cardiac safety of new compounds in Phase I trials. The services provide clients with an earlier assessment of the safety risk of their drug and potentially eliminates the need for a separate Thorough QT (TQT) study in later stages of development.
Since 2005, the FDA has required all new compounds in development to be tested for cardiac safety. A dedicated TQT study determines the compound’s impact on the QT interval - the time between the start of the Q wave and the end of the T wave during the heart’s electrical cycle. A prolonged QT interval indicates a potential safety risk for a new drug.
TQT studies typically occur with Phase II or III trials however, the results of a prospective validation study carried out in December 2014 through a collaboration between the FDA and Cardiac Safety Research Consortium, demonstrated that actionable cardiac safety assessments can be conducted in Phase I trials using ECGs collected during routine SAD or MAD studies.
“ICON and iCardiac have frequently worked together on QT assessment studies, and that working experience has repeatedly confirmed the strong expertise that ICON possesses in ensuring that cardiac safety data of the highest quality is acquired during their Phase I studies,” said Alex Zapesochny, president and chief executive officer of iCardiac Technologies. “We look forward to continuing to work closely with ICON to bring the many benefits of Early Precision QT to their clients.”
