Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double‐Blind, Randomized, Placebo‐Controlled Phase 1 Clinical Study

• Published in: Clinical pharmacology in drug development Vol. 7; no. 4; pp. 408 - 421
• Main Authors: Hunt, Hazel, Donaldson, Kirsteen, Strem, Mark, Zann, Vanessa, Leung, Pui, Sweet, Suzanne, Connor, Alyson, Combs, Dan, Belanoff, Joseph
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.05.2018; John Wiley and Sons Inc
• Subjects: Administration, Oral; Area Under Curve; CORT125134; Cushing syndrome; Dose-Response Relationship, Drug; Double-Blind Method; Double-blind studies; Drug Administration Schedule; Female; First‐in‐Human; Glucocorticoid; Half-Life; Healthy Volunteers; Humans; Male; Original Manuscript; Pharmacokinetics; Pharmacological effect; Pharmacology; Receptors, Glucocorticoid - antagonists & inhibitors; Small Molecule Libraries - administration & dosage; Small Molecule Libraries - adverse effects; Small Molecule Libraries - pharmacokinetics; First-in-Human; CORT125134; Glucocorticoid; Pharmacological effect; Cushing syndrome

CORT125134 is an orally active, high‐affinity, selective antagonist of the glucocorticoid receptor that is being developed for indications that may benefit from the modulation of cortisol activity. This first‐in‐human study was conducted to evaluate the dose‐related safety, tolerability, pharmacokin...