Phase 1 QT Studies
Preclinical / Phase I
ICON provides strategy and management in support of non-clinical drug development for all Phases.
ICON is proud to be a leading provider of iCardiac’s Early Precision QT® (EPQT) methodology. With proven expertise in high precision ECG data collection (<6 msec SD), ICON’s Clinical Research Unit (CRU) is well-positioned to serve your early phase testing needs with this breakthrough methodology.
What is Early Precision QT – and why is this important to you?
Leveraging iCardiac’s Early Precision QT analysis, ICON offers a cost-effective alternative to Thorough QT (TQT) studies. Combining its High Precision QT analysis method and Exposure Response (ER) modeling, this approach empowers accelerated cardiac safety analysis in First in Man studies.
- 2014 - FDA announced the results of the IQ-CSRC study, confirming the utility of EPQT in providing reliable information about a compound’s cardiac safety profile.
- September 2015 - FDA approved the first Thorough QT waiver based on analysis completed by iCardiac using their EPQT methodology.
- Result: the sponsor company saved the costs of running a TQT study on this compound ($2M-$5M), and applied these to other clinical priorities in their pipeline.
- December 2015 - a revision to ICH E14 guidance on cardiac safety enabled ECGs from Phase I studies to be used to conclusively demonstrate a drug’s QT effect.
- Clients that submit QT data that meet certain defined standards, as defined in the ICH revision document, may seek a waiver from having to conduct a TQT study.
- Proven success - ICON completed multiple studies involving EPQT ECG capture (<6 msec SD) in partnership with iCardiac
Take advantage of Early Precision QT at ICON's Clinical Research Unit and access:
Fast, definitive results. Bring your product to market faster with proven high precision ECG collection, 10x the ECG data, higher quality cardiac beats, and low data variability.
Cost-effective assessment. Marginal costs for including EQPT in a First in Man SAD/MAD study is $15k for ECG capture and $150k for full QT analysis vs $2M - $5M cost of a traditional TQT study
De-risked development. De-risk your compound relative to QT liability during Phase I. EPQT's earlier cardiac safety assessment empowers confident and cost-effective drug development.
Better pipeline prioritization. EPQT delivers definitive QT liability information during the early stages of the development process, enabling you to make more informed decisions.