NCT05003713

Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CORT125236	CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
DRUG	Placebo matching CORT125236	Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
DRUG	Prednisone	Prednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration

Timeline

• Start date: 2021-08-03
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2021-08-12
• Last updated: 2023-03-22

Locations

1 site across 1 country: United Kingdom