NCT04672512

Single and Multiple Ascending Dose Study of CORT125329 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 CORT125329 in Healthy Subjects, With an Optional Pharmacological Effects Cohort

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the dose-related safety, tolerability, pharmacokinetics (PK) and pharmacological effects (PD) of CORT125329 after single and multiple ascending oral doses of CORT125329 lipid capsule formulations in healthy participants.

Detailed description

This is a 3-part, single-center study of single and multiple ascending doses of CORT125329 in healthy participants. Part 1 will be a double-blind, randomized, placebo-controlled assessment of single ascending doses (SAD) of CORT125329 lipid capsule formulations. Participants will be enrolled sequentially into 1 of up to 8 cohorts, each containing 8 participants. Part 2 will be double-blind, randomized, placebo-controlled assessments of multiple oral ascending doses (MAD) of CORT125329 lipid capsule formulations. Participants will be enrolled sequentially into 1 of up to 4 cohorts, each containing 8 participants. Optional Part 3 will be an open-label, 2-way fixed sequence cross-over study and will serve as proof of PD (glucocorticoid receptor modulation) for CORT125329 lipid capsule formulations. Participants will be enrolled in a single cohort of 10 participants. Throughout the study, routine safety tests will be performed. In selected parts of the study, assessments of PK (CORT125329), changes in serum cortisol and plasma adrenocorticotrophic hormone (ACTH), and changes in hematological and bone biomarkers will be measured.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CORT125329 lipid capsule formulation	CORT125329 lipid capsule formulation 1 or 2 for oral administration
DRUG	Placebo	Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration
DRUG	Prednisone	Prednisone tablet for oral administration

Timeline

• Start date: 2020-10-23
• Primary completion: 2022-01-17
• Completion: 2022-01-17
• First posted: 2020-12-17
• Last updated: 2022-02-09

Locations

1 site across 1 country: United Kingdom