Active Ingredient: SOLRIAMFETOL
In a randomized, double-blind, placebo- and positive-controlled, 4-period crossover Thorough QT (TQT) study of 55 healthy adults, single therapeutic (300 mg) and supratherapeutic (900 mg) oral doses were evaluated alongside moxifloxacin (400 mg) as a positive control. For both solriamfetol doses, the upper bounds of the 2-sided 90% confidence intervals for the baseline- and placebo-adjusted corrected QT (ΔΔQTcF) remained strictly below the 10-ms regulatory threshold at all post-dose time points. No categorical outliers (ΔQTcF>60 ms or absolute QTcF>480 ms) were observed.
https://doi.org/10.1002/cpdd.867