Assessment of the cardiac safety and pharmacokinetics of a short course, twice daily dose of orally-administered mifepristone in healthy male subjects.

Background: Mifepristone is approved to control hyperglycemia in adults with endogenous Cushing's syndrome and is described as a mildly QTc prolonging drug, based on a TQT study. The aim of the present study was to assess the effect of mifepristone on the QTc interval at plasma mifepristone concentrations exceeding those observed in the TQT study.

Methods: Twenty healthy, male volunteers were given three doses of 1200 mg mifepristone every 12 h with a high-fat meal in a randomized, placebo-controlled 2-period crossover study.