QTMeds

KOSELUGO 10 mg

Clinical Description (Database Summary)

In a thorough QT crossover study of 54 healthy male subjects, a single therapeutic dose of 75 mg resulted in a maximum placebo-corrected QTcF change (ΔΔQTcF) of only 2.5 ms (upper 90% CI), well below the 10 ms regulatory threshold. Modeling and simulation also predicted that a supratherapeutic dose of 150 mg would not cause clinically relevant QT prolongation (predicted upper 90% CI: 6.95 ms).

Scientific Sources / References

https://doi.org/10.1016/j.clinthera.2016.10.004