Early cardiac assessment studies to determine cardiac safety profile

February is Heart Month, a time to raise awareness on cardiovascular health. Cardiac safety issues are one of the main reasons promising drugs are halted in development.

With the collaboration of a number of leading core ECG vendors and our in-house clinical units specially designed for assessing cardiac safety, Altasciences has designed and conducted over 30 early cardiac safety and QT prolongation studies.

Whether you choose to conduct your cardiac assessment trials earlier (such as in first-in-human studies) or a little later (after completing Phase II), you can benefit from the following advantages:

Early QT Assessment Advantages

  • Potential elimination of the traditional TQT study for some drugs if the early trial is scientifically rigorous and adequately designed; provides preparatory information for cases where the TQT study will need to be completed.
  • Improved development package for licensing or further in-house development
  • Considerable time and cost savings if TQT waiver is obtained
  • Possibility to collect data and analyze later in development cycle

Thorough QT Assessment Advantages

  • By waiting to run a TQT study after Phase II, the derisking occurs later in development and the cost is incurred only for compounds clearly showing potential.
  • By end of Phase II, the understanding of the pharmacokinetics of the parent and potential active metabolites and how they relate to efficacy has been more elucidated.

In this issue of The Altascientist, we discuss the ICH regulations, and provide a thorough review of the design and timing of QT studies for your drug development program.

Included is a recent case study on the QT assessment in a novel cannabis trial involving 80 subjects.