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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03335956 | CORT125281 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) | PHASE1 | COMPLETED | 48 | — | — | Sep 21, 2017 | Jun 25, 2018 | Jul 26, 2018 | 1 | United Kingdom |
| 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...