Pharmacokinetics
In all study arms where elamipretide was administered with a topical or systemic drug, elamipretide AUC0-6h was not significantly different compared to that after administration of elamipretide alone. Ice application arm demonstrated a statistically significant impact on elamipretide Cmax and AUC0-6h compared to elamipretide alone. Specifically, mean (SD) Cmax of elamipretide was reduced by ~23% (1693.0±369.23 vs 2213.0±634.54 ng/mL, p=0.0003) and the AUC0-6h of elamipretide was reduced by ~12% (4747.8±818.99 vs 5401.3±1096.06 ng/mL•h, p<0.0001). Ice application arm showed a statistically significant reduction of Cmax (407.9±81.72 vs454.1±70.24 ng/mL, p=0.0028) and AUC0-6h (1849.1±352.12vs 2079.1±278.81 ng/mL•h, p<0.0001) for the M1 metabolite and AUC0-6h (210.7±32.65 vs239.4±27.09 ng/mL•h, p=0.0135) for the M2 metabolite.