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Also known as CORT125329 lipid capsule formulation
CORT125329 lipid formulation · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAD Cohort A CORT125329 | EXPERIMENTAL | Participants will receive a single dose of CORT125329 30 mg lipid capsule formulation 1 in the fasted state on Day 1 |
| SAD Cohort B CORT125329 | EXPERIMENTAL | Participants will receive a single dose of CORT125329 lipid capsule formulation 1 in the fasted state on Day 1. The dose will be determined after review of safety, tolerability, and PK data from SAD Cohort A. |
| SAD Cohorts C through H CORT125329 | EXPERIMENTAL | Participants will receive a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts. |
| SAD Cohorts A through H Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 in a dose escalation format. The dose, formulation, and prandial state for each placebo cohort will match that used in the corresponding CORT125329 cohort. |
| MAD Cohorts A through D CORT125329 | EXPERIMENTAL | Participants will receive CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency (once- or twice-daily), formulation, and prandial state for each cohort will be determined after review of safety, tolerability, and PK data from previous cohorts. |
| MAD Cohorts A through D Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Days 1 through 14 in a dose escalation format. The dose, dose frequency, formulation, and prandial state for each cohort will match that used in the corresponding CORT125329 cohort. |
| Pharmacodynamic (PD) Effect Cohort | EXPERIMENTAL | Participants will receive a single dose of prednisone 25 mg in the fasted or fed state on Day 1 of Period 1. The prandial state for the Period 1 treatment will be determined after review of safety and tolerability data from the SAD Cohorts. After a 7-day washout period, participants will receive a single dose of prednisone 25 mg and a single dose of CORT125329 lipid capsule formulation 1 or 2 in the fasted or fed state on Day 1 of Period 2. The formulation and dose level of CORT125329 treatment in Period 2 will be determined after review of safety, tolerability, and PK data from the SAD cohorts. The prandial state for treatment in Period 2 will be the same used in Period 1. |
| Name | Type | Description |
|---|---|---|
| CORT125329 lipid capsule formulation | DRUG | CORT125329 lipid capsule formulation 1 or 2 for oral administration |
| Placebo | DRUG | Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration |
| Prednisone | DRUG | Prednisone tablet for oral administration |
Inclusion Criteria: * Body mass index of 18.0 to 30.0 kg/m\^2 * Weight of ≤102 kg * Must agree to adhere to the contraception requirements * Additional criteria apply. Exclusion Criteria: * Received any investigational medicinal product in a clinical research study within the 90 days * History of...
CORT125329 lipid formulation is an investigational small molecule developed by Corcept Therapeutics Incorporated. It is a lipid capsule formulation of CORT125329 that has been studied in a Phase 1 clinical trial in healthy adult participants. The specific therapeutic indications for this formulation have not been disclosed.
CORT125329 lipid formulation is being developed by Corcept Therapeutics Incorporated, which trades on the Nasdaq under the ticker CORT. Corcept is the sponsor of the clinical program evaluating this lipid capsule formulation of CORT125329.
CORT125329 lipid formulation is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program has been completed, with one trial conducted to date.
CORT125329 lipid formulation has been evaluated in one completed Phase 1 trial, NCT04672512, titled Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants. The trial enrolled 115 healthy adult volunteers in the United Kingdom and used a randomized, double-blind, placebo-controlled design.
Yes, CORT125329 lipid formulation and CORT125329 lipid capsule formulation refer to the same investigational drug candidate from Corcept Therapeutics. The two names describe the same lipid-based capsule formulation of CORT125329.
The Phase 1 trial NCT04672512 evaluated single and multiple ascending doses of CORT125329 lipid formulation in 115 healthy participants in the United Kingdom. It was a randomized, double-blind, placebo-controlled study in adults aged 18 years and older, and it has been completed.