Active Ingredient: ELTROMBOPAG
In a randomized, double-blind, placebo- and positive-controlled, 4-period crossover Thorough QT (TQT) study of 87 healthy volunteers, therapeutic (50 mg) and supratherapeutic (150 mg) oral doses administered daily for 5 days were evaluated. Moxifloxacin (400 mg) served as the positive control. For both eltrombopag doses, the upper bounds of the 90% confidence intervals for the baseline- and placebo-adjusted corrected QT (ΔQTcF) remained strictly below the 10-ms regulatory threshold at all post-dose time points. The maximum observed mean treatment difference for the 150 mg dose was only 2.29 ms (90% CI: 0.34,4.24) at 1 hour post-dose.
https://doi.org/10.1111/j.1365-2125.2010.03646.x, https://www.fda.gov/media/178811/download