Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants
Status:
Completed
Trial end date:
2020-10-04
Target enrollment:
Participant gender:
Summary
This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple
ascending doses (MAD; Part 2) of CORT113176 in healthy participants; Part 3 is an optional
part to investigate whether CORT113176 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 pharmacokinetic (PK) and safety data obtained from
completed cohorts. The first MAD cohort will not start until data are available from at least
2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect
cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The
expected exposure for the daily MAD level at steady state (taking into consideration
potential accumulation on repeat dosing) must not exceed the highest exposure considered to
be safe and well tolerated during preceding SAD cohorts.