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QTc Working Group
The IQ QTc Working Group aims to add value to pharmaceutical industry and health authorities by exploring innovative approaches to QTc liability and risk assessment in early clinical drug development.
The primary research task of the QTc Working Group in 2014 will be to explore the potential for QTc results in early clinical drug development to replace the thorough QT (TQT) study in collaboration with the Cardiac Safety Research Consortium (CSRC)and FDA.
In collaboration with the FDA-IRT and the CSRC, the IQ QTc Working Group conducted a Phase 1 clinical research study designed to mimic the standard SAD/MAD studies in early clinical development that would test the positive and negative predictivity of the concentration-QTc response modeling in Phase 1 for the outcome of the TQT study. The study included five currently marketed drugs from the FDA data base of agents that have had a positive TQT study plus a placebo or a drug, which clearly does not prolong QTc.
The QT working group has completed its goal of conducting the prospective study of QTc prolongation in early phase 1 with 5 known positive drugs (ondansetron, quinine, dolasetron, moxifloxacin and dofetilide) and one known negative drug (levocetirizine). The concentration-QTc relationship showed a statistically significant positive slope for the five positive compounds and no slope for the negative compound. The results were presented and discussed at a workshop sponsored by IQ and CSRC at the FDA White Oak campus on Dec. 12th. The results have also been published in CPT. FDA has begun granting waivers of conducting TQT studies on the basis of such data.