Diane M Donegan, Rosario Pivonello, Antonio Stigliano, Pina Lardo, Tara Kearney, Emese Mezősi, Ezio Ghigo, Roberta Giordano, Cary N Mariash, Richard A Feelders, Kirsteen Donaldson, Borje Darpo, Hongqi Xue, Joseph M Custodio, Austin L Hand, Andreas G Moraitis
OBJECTIVE: To assess the effect of relacorilant, a selective glucocorticoid receptor modulator under investigation for the treatment of patients with endogenous hypercortisolism (Cushing syndrome [CS]), on the heart rate-corrected QT interval (QTc). METHODS: Three clinical studies of relacorilant were included: (1) a first-in-human, randomized, placebo-controlled, ascending-dose (up to 500 mg of relacorilant) study in healthy volunteers; (2) a phase 1 placebo- and positive-controlled thorough QTc (TQT) study of 400 and 800 mg of relacorilant in healthy volunteers; and (3) a phase 2, open-label study of up to 400 mg of relacorilant administered daily for up to 16 weeks in patients with CS...
January 2024: Endocrine Practice