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Also known as Exicorilant
CORT125281 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAD Part 1 Placebo Cohort 1 Period 1 | PLACEBO_COMPARATOR | - |
| SAD Part 1 Active Cohort Period 1 | EXPERIMENTAL | - |
| SAD Part 1 Placebo Cohort 1 Period 2 | PLACEBO_COMPARATOR | - |
| SAD Part 1 Active Cohort 1 Period 2 | EXPERIMENTAL | - |
| SAD Part 1 Placebo Cohort 1 Period 3 | PLACEBO_COMPARATOR | - |
| SAD Part 1 Active Cohort 1 Period 3 | EXPERIMENTAL | - |
| SAD Part 2 Placebo Cohort 2 Period 4 | PLACEBO_COMPARATOR | - |
| SAD Part 2 Active Cohort 2 Period 4 | EXPERIMENTAL | - |
| SAD Part 2 Placebo Cohort 2 Period 5 | PLACEBO_COMPARATOR | - |
| SAD Part 2 Active Cohort 2 Period 5 | EXPERIMENTAL | - |
| SAD Part 2 Placebo Cohort 2 Period 6 | PLACEBO_COMPARATOR | - |
| SAD Part 2 Active Cohort 2 Period 6 | EXPERIMENTAL | - |
| MAD Placebo Cohort 1 | PLACEBO_COMPARATOR | - |
| MAD Active Cohort 1 | EXPERIMENTAL | - |
| MAD Placebo Cohort 2 | PLACEBO_COMPARATOR | - |
| MAD Active Cohort 2 | EXPERIMENTAL | - |
| MAD Placebo Cohort 3 | PLACEBO_COMPARATOR | - |
| MAD Active Cohort 3 | EXPERIMENTAL | - |
| MAD Placebo Cohort 4 | PLACEBO_COMPARATOR | - |
| MAD Active Cohort 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CORT125281, 40mg, fasted | DRUG | CORT125281 is supplied as capsules for oral dosing |
| Prednisone 25mg, fasted | DRUG | Challenge Agent, Dose and Route of Administration: Standard release 25 mg tablets, orally administered |
| Placebo oral capsule, fasted | DRUG | Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered |
| Pioglitazone 15mg Tablet | DRUG | Probe Substrate, Dose and Route of Administration: 15 Mg tablet, orally administered |
| Placebo oral capsule, fed | DRUG | Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered |
| Prednisone 25mg, fed | DRUG | Challenge Agent, Dose and Route of Administration: Standard release 25 mg tablets, orally administered |
| CORT125281, 120mg, fasted | DRUG | CORT125281 is supplied as capsules for oral dosing |
| CORT125281, 360mg, fasted | DRUG | CORT125281 is supplied as capsules for oral dosing |
| CORT125281, 720mg, fasted | DRUG | CORT125281 is supplied as capsules for oral dosing |
| CORT125281, 360mg, fed | DRUG | CORT125281 is supplied as capsules for oral dosing |
| CORT125281, 360mg | DRUG | CORT125281 is supplied as capsules for oral dosing twice, 12 hours apart, fasted (morning) and after evening meal |
| CORT125281, 120mg | DRUG | CORT125281 is supplied as capsules for oral dosing once daily |
| CORT125281, 180mg | DRUG | CORT125281 is supplied as capsules for oral dosing twice daily |
| CORT125281, 240mg | DRUG | CORT125281 is supplied as capsules for oral dosing twice daily |
| Placebo oral capsule | DRUG | Reference Therapy, Dose and Route of Administration: Placebo capsule, orally administered twice, 12 hours apart, fasted (morning) and after evening meal |
Inclusion Criteria: 1. Give written informed consent 2. If male, have undergone vasectomy, with no wish to have the procedure reversed 3. If female, using appropriate precautions to avoid pregnancy, defined as of nonchildbearing potential (ie, postmenopausal or permanently sterilised) or using high...
CORT125281 is an investigational small molecule developed by Corcept Therapeutics Incorporated. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United Kingdom. The trial has been completed, and no specific disease indication has been disclosed for this compound.
CORT125281 is being developed by Corcept Therapeutics Incorporated, which trades on the Nasdaq under the ticker CORT. The company sponsored the Phase 1 trial of the compound conducted in the United Kingdom.
CORT125281 is in Phase 1 development. One Phase 1 trial, NCT03335956, has been completed. The study was a single ascending dose and multiple ascending dose trial that enrolled 48 healthy adult volunteers. No later-phase trials have been recorded for this compound.
CORT125281 has been studied in one completed Phase 1 trial, NCT03335956, titled CORT125281 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD). The trial enrolled 48 healthy volunteers in the United Kingdom, was randomized, double-blind, and placebo-controlled, and included participants aged 18 years and older.