Can an early phase clinical pharmacology study replace a thorough QT study?
Pitolisant lacked an effect of regulatory concern on QTc interval in both the studies, however analysed, suggesting that the results from the SAD study could have mitigated the need for a TQT study. Our findings add to the growing evidence that intensive ECG monitoring in early phase clinical studies can replace a TQT study.
DLBS3233, as a combination of herbal extracts, holds promise in the treatment of type 2 diabetes, and possibly also in prevention of the disease.