2
Clinical Trials associated with CORT-125236A two-part, open-label, single-dose study designed to assess the mass balance recovery, metabolite profile and metabolite identification of [14C]-CORT125236 in healthy male subjects and to assess pharmacokinetics of CORT125236 tablet, including food effect in healthy subjects
A Phase I Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT125236 in Healthy Subjects, With an Optional Pharmacological Effects Cohort
This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT125236 in healthy participants; Part 3 is optional, to investigate whether CORT125236 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by the pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 3 SAD levels to allow MAD administration to proceed. The decision on whether to start Part 3 can be made at any point after completion of 3 SAD levels, and will be based on achieving sufficiently high plasma CORT125236 exposure in Part 1 of the study.
100 Clinical Results associated with CORT-125236
100 Translational Medicine associated with CORT-125236
100 Patents (Medical) associated with CORT-125236
100 Deals associated with CORT-125236