CORT125134 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)

Phase 1 Completed 130 enrolled Corcept Therapeutics

RandomizedParallel-groupDouble-blindBasic science

Summary

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125134 and its active metabolite CORT125201 after single and multiple ascending oral doses of CORT125134 in healthy participants.

Timeline

Start: 2014-09
Primary completion: 2015-12
Completion: 2015-12

Publications

Background Hunt H, Donaldson K, Strem M, Zann V, Leung P, Sweet S, Connor A, Combs D, Belanoff J. Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study. Clin Pharmacol Drug Dev. 2018 May;7(4):408-421. doi: 10.1002/cpdd.389. Epub 2017 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mifepristone	Small molecule	600 mg	—
Subject	Relacorilant	Small molecule	5 mg	Oral
Subject	Relacorilant	Small molecule	400 mg	Oral
Background	Prednisone	Other / unclassified	25 mg	—

Indications

No indication recorded.