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CORT125236 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD Cohorts A through F CORT125236 | EXPERIMENTAL | Cohorts will receive a single dose of CORT125236 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. Cohort A will receive a 20-mg dose in a fasted state. Cohort B will receive a ≤3-fold increase in dose from Cohort A in a fasted state; the dose level and dose regimen (whether to split the dose) will be determined after evaluation of safety and PK data for Cohort A. Subsequent cohorts will receive a ≤3-fold increase in CORT125236 dose from the previous cohort in a fasted or fed state; the dose level, dose regimen, and prandial state will be determined after evaluation of safety and PK data from previous cohorts. |
| Part 1: SAD Cohorts A through F Placebo | PLACEBO_COMPARATOR | Cohorts will receive a single dose of placebo matching CORT125236 lipid capsule formulation by mouth on Day 1. The dose regimen and prandial state will be the same as those for the cohort members receiving CORT125236. |
| Part 2: MAD Cohorts A through D CORT125236 | EXPERIMENTAL | Cohorts will receive once- or twice-daily doses of CORT125236 lipid capsule formulation by mouth for 14 days. The anticipated exposure will not exceed the highest exposure considered safe and well-tolerated during Part 1. The dose level, dose schedule, and prandial state for each cohort will be determined after evaluation of safety and PK data from Part 1 and preceding Part 2 cohorts. |
| Part 2: MAD Cohorts A through D Placebo | PLACEBO_COMPARATOR | Cohorts will receive once- or twice-daily doses of placebo matching CORT125236 lipid capsule formulation by mouth for 14 days. The dose regimen and prandial state will be the same as those for the cohort members receiving CORT125236. |
| Part 3: Single Dose Pharmacodynamic Effect | EXPERIMENTAL | In Period 1, participants will receive a single dose of prednisone 25 mg (20 mg + 5 mg) tablet by mouth on Day 1 in a fasted or fed state. After a 7-day washout, in Period 2, participants will receive a single dose of prednisone as in Period 1 plus a single dose of CORT125236 lipid capsule formulation by mouth on Day 1 in a fasted or fed state. The dose of CORT125236 and the prandial state will be determined after evaluation of safety and PK data from Part 1. Part 3 of the study is optional. |
| Name | Type | Description |
|---|---|---|
| CORT125236 | DRUG | CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration |
| Placebo matching CORT125236 | DRUG | Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration |
| Prednisone | DRUG | Prednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration |
Inclusion Criteria: * Body mass index 18.0 to 30.0 kg/m\^2, inclusive * Body weight ≤102 kg * Willing to consume a high-fat breakfast, including pork * Adheres to the contraception requirements of the protocol * Additional criteria apply. Exclusion Criteria: * Received any investigational drug or...
CORT125236 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a completed trial evaluating single and multiple ascending doses. The drug is being developed by Corcept Therapeutics Incorporated.
CORT125236 is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company. The company's stock trades under the ticker CORT. The drug is an investigational small molecule currently in Phase 1 clinical development.
CORT125236 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied single and multiple ascending doses in healthy participants. The drug is investigational and has not been approved by regulatory authorities.
CORT125236 has one completed Phase 1 clinical trial, identified as NCT05003713. This trial was a single and multiple ascending dose study in healthy participants, conducted in the United Kingdom with 82 enrolled participants. The trial was randomized, double-blind, and placebo-controlled.
CORT125236 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Corcept Therapeutics Incorporated and is currently in Phase 1 clinical development.