Pharmacokinetic Analysis
The PK population included 106 participants randomized and treated with elamipretide, with at least 1 PK sample taken during their participation. PK modeling for elamipretide and its metabolites, M1 and M2, were performed using NONMEM computer software. Covariates, such as age, genotype, weight, height, lean body mass, body mass index, liver function tests, serum creatinine, and renal function (as described by estimated glomerular filtration rate [eGFR]) were analyzed. The exposure-response analysis examined response based on the 6MWT as a function of steady-state exposure to elamipretide and its metabolites.