Safety
Apart from data relating to ISRs, which were not captured as AEs because
they were the designated study endpoints, few TEAEs were reported in
this study on daily SC elamipretide doses of 60 mg. The only TEAE
observed in more than one subject was that of somnolence in the
diphenhydramine treatment arm, where five subjects (50%) reported mild
somnolence. Although it is reasonable to suspect that night-time
administration of diphenhydramine could reduce the occurrence of
somnolence, doing so was not a part of the study protocol. Therefore, a
conclusions cannot be drawn here. There were no apparent differences
between any treatment arms with respect to vital signs, ECG parameters,
or laboratory values.