PMID- 32255542 OWN - NLM STAT- MEDLINE DCOM- 20210812 LR - 20210812 IS - 2160-7648 (Electronic) IS - 2160-763X (Linking) VI - 9 IP - 6 DP - 2020 Aug TI - Randomized, Double-Blind, Single-Dose, Placebo-Controlled Crossover Study to Evaluate the Effects of Esaxerenone on QTc Interval in Healthy Subjects. PG - 709-718 LID - 10.1002/cpdd.794 [doi] AB - This phase 1 single-center, single-dose, double-dummy, placebo-controlled, 4-period and 4-sequence crossover study assessed the potential of esaxerenone, a novel nonsteroidal mineralocorticoid receptor blocker used to treat hypertension, to affect cardiac repolarization. In this double-blind study, 55 subjects were randomized to single doses of 10 mg esaxerenone (therapeutic dose), 40 mg esaxerenone (supratherapeutic dose), 400 mg moxifloxacin, or placebo. Serial electrocardiograms and pharmacokinetics (PK) were obtained over 24 and 168 hours, respectively. The primary end point was Fridericia-corrected QT interval (QTcF). Secondary end points included safety and PK. Assay sensitivity was confirmed as the lower limit of 90% confidence interval (90%CIs) for placebo-corrected change from baseline QTcF (∆∆QTcF) for moxifloxacin was >5 milliseconds at the prespecified times; mean ∆∆QTcF was 12.5 milliseconds at 3 and 4 hours postdose. The upper 90%CI limits of ∆∆QTcF were