Pharmacokinetics
In all study arms where elamipretide was administered with a topical or
systemic drug, elamipretide AUC0-6h was not
significantly different compared to elamipretide alone. Ice application
arm statistically significantly impacted elamipretide
Cmax and AUC0-6h compared to
elamipretide alone. Mean (SD) Cmax of elamipretide was
reduced by ~23% (1693.0±369.23 vs2213.0±634.54ng/mL, p=0.0003) and the AUC0-6h of
elamipretide was reduced by ~12% (4747.8±818.99vs 5401.3±1096.06ng/mL•h, p<0.0001). Ice application
arm showed a statistically significant reduction of Cmax(407.9±81.72 vs 454.1±70.24ng/mL, p=0.0028) and
AUC0-6h (1849.1±352.12 vs 2079.1±278.81ng/mL•h,
p<0.0001) for the M1 metabolite and AUC0-6h(210.7±32.65 vs 239.4±27.09ng/mL•h, p=0.0135) for M2 metabolite.