NCT04249323

Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

A Phase 1 Adaptive Dose, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered CORT113176 in Healthy Subjects, With an Optional Pharmacological Effects Cohort

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (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 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.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	CORT113176 Lipid Capsule Formulation	CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
DRUG	Placebo matching CORT113176 Lipid Capsule Formulation	Placebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
DRUG	Prednisone	Prednisone standard release tablets 1 x 20 mg plus 1 x 5 mg for oral administration

Timeline

• Start date: 2020-01-27
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2020-01-30
• Last updated: 2022-02-01

Locations

1 site across 1 country: United Kingdom