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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 being developed by Corcept Therapeutics Incorporated (ticker: CORT). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other.
CORT125329 lipid formulation is being studied for use in healthy participants. It is currently in Phase 1 clinical development, and its intended therapeutic use has not been established. The drug is an investigational small molecule developed by Corcept Therapeutics Incorporated.
CORT125329 lipid formulation is developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded under the ticker CORT. The drug is an investigational small molecule currently in Phase 1 clinical development.
CORT125329 lipid formulation is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 study of the drug in healthy participants has been completed.
CORT125329 lipid formulation has been studied in one clinical trial, NCT04672512, titled "Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants." This Phase 1 trial was completed, enrolled 115 participants, and was conducted in the United Kingdom.
CORT125329 lipid formulation is a specific formulation of the drug CORT125329. The clinical trial NCT04672512 studied this lipid formulation in healthy participants. The drug is being developed by Corcept Therapeutics Incorporated.