Active Ingredient: OMAVELOXOLONE
In a randomized, crossover thorough QT study (NCT05927649) of 30 healthy adults, a single supratherapeutic dose of 450 mg was administered with a high-fat meal. This achieved a mean Cmax of 319 ng/mL, approximately 4.5-fold higher than the steady-state exposure of the approved 150 mg dose. The upper limit of the 90% confidence interval for the placebo-corrected change in QTcF (ΔΔQTcF) remained consistently below 10 ms at all timepoints. Pharmacokinetic modeling of major metabolites (M17 and M22) also confirmed no clinically significant QTc prolongation.
https://doi.org/10.1111/cts.70139