QT / QTc Analysis (TQT) for cardiac safety

PhinC Development: a pioneer in exploring cardiac safety in early phase

PhinC Development has been pioneer in the use of concentration-response modeling approach to document QT-liability through intensive ECG monitoring from first-in-human studies to ICH E14 dedicated TQT study.

Since its revision in 2015, the ICH E14 guideline now accepts the use of C-R (Concentration-Response) approach applied to first-in-human studies as a possible alternative to the TQT study.

Indeed, the TQT is a resource intensive and expensive study dedicated only to ECG assessment per time point, and cannot be conducted until the potential therapeutic dose is characterized. By contrast to this classical approach, C-R analysis consider all the ECG collected simultaneously with the systemic exposure to the drug.

Such evaluation was shown to be sufficiently powerful and suitable in first-in-human studies, typically SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) studies performed on healthy volunteers to support a QT waiver for some drugs.

PhinC Development initiates preliminary C-R models, useful for predictions, which are essential for assessing the QT-interval prolongation risk, and if any, efficient adaptation of your regulatory ECG monitoring plan.

PhinC Development holds long term experience on QT/TQT studies conception and can thus help you limit any additional costs during the QT process.

Cardiabase-Banook, a partner of choice for TQT studies

PhinC Development has established a partnership with Cardiabase-Banook Group, the best cardiac core lab in Europe. The company specializes in data acquisition, processing, analysis, reporting and archiving for digital and paper ECG as well as holter monitoring. Working with these cardiology experts ensures to achieve state-of-the-art and regulation compliant TQT studies.

To know more: Cardiac Safety on the Cardiabas-Banook website.

Club Phase 1
GMP - Groupe de Métabolisme et Pharmacocinétique
EUFEMED
AFSSI