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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 developed by Corcept Therapeutics Incorporated. It has been studied in a Phase 1 clinical trial in healthy adult participants in the United Kingdom. No approved indication has been announced for CORT125236, and it remains in early clinical development.
CORT125236 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 CORT125236, including the Phase 1 study conducted in the United Kingdom.
CORT125236 is in Phase 1 clinical development. Its single Phase 1 trial, a single and multiple ascending dose study in healthy participants, has been completed. CORT125236 is investigational and has not been approved by the FDA for any indication.
CORT125236 has been evaluated in one Phase 1 trial, NCT05003713, titled a Single and Multiple Ascending Dose Study of CORT125236 in Healthy Participants. The trial enrolled 82 healthy volunteers in the United Kingdom, was randomized, double blind, and placebo controlled, and is now completed.
The CORT125236 Phase 1 trial, NCT05003713, was a randomized, double blind, placebo controlled single and multiple ascending dose study. It enrolled 82 healthy participants aged 18 years and older of all sexes in the United Kingdom. The study has been completed.