Pharmacokinetics
Population pharmacokinetic models were fit successfully to 3 analytes, elamipretide and 2 metabolites, M1 and M2. For elamipretide, systemic parameters scaled allometrically. No covariates influenced the systemic or absorption parameters. For M1 and M2, apparent clearance decreased with age and increased with renal function. No other covariates influenced the systemic parameters. In the exposure-response analysis, participants with an nDNA alteration had an increase in the change and fractional change at week 24 compared with that at day 1 (i.e., baseline) value for the 6MWT as a function of the elamipretide steady state area under the curve (