Active Ingredient: FUTIBATINIB
In a 4-period crossover Phase 1 Thorough QT study of 48 healthy subjects, single therapeutic (20 mg) and supratherapeutic (80 mg) oral doses were compared against placebo and moxifloxacin (400 mg). The upper limits of the two-sided 90% confidence intervals for the placebo-corrected change from baseline in QTcF remained strictly below the 10-ms regulatory threshold across all post-dose time points (range: 2.0–4.5 ms). No significant relationship was detected between futibatinib plasma concentration and delta QTcF, and no adverse effects on heart rate, PR/QRS intervals, or ECG morphology were observed.
https://doi.org/10.1002/cpdd.1195