Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04672512 | Single and Multiple Ascending Dose Study of CORT125329 in Healthy Participants | PHASE1 | COMPLETED | 115 | — | — | Oct 23, 2020 | Jan 17, 2022 | Feb 9, 2022 | 1 | United Kingdom |
| 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...