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CORT125134 · 5 trials · 2 indications
All treatment-emergent adverse events were recorded and summarized.
All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.
Statistical analysis of these data will be used to estimate the highest oral dose of CORT125134 current capsule formulation steady state AUC0-24h of plasma CORT125134.
| Arm | Type | Description |
|---|---|---|
| Group 1: Low-dose Group | EXPERIMENTAL | 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. There was no washout between treatment periods. Period 3 was followed by a 4-week follow-up period. Per-protocol, Group 1 did not participate in treatment Period 4. |
| Group 2: High-dose Group | EXPERIMENTAL | 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period. |
| Cohort 1 | EXPERIMENTAL | Subjects will receive CORT125134 150 mg once daily for 14 days |
| Cohort 2 | EXPERIMENTAL | Subjects will receive CORT125134 250 mg once daily for 14 days |
| Cohort 3 | EXPERIMENTAL | Subjects will receive CORT125134 once daily for 14 days at a dose level decided based on evaluation of steady state exposure from Cohorts 1 and 2 |
| Cohort 4 (optional) | EXPERIMENTAL | Subjects will receive CORT125134 once daily for 14 days at a dose level decided based on evaluation of steady state exposure from Cohorts 1, 2, and 3, if it is considered that this cohort would aid achievement of the study objectives |
| [14C]-CORT125134 | EXPERIMENTAL | Two capsules each containing 125 milligrams (mg) \[14C\]-CORT125134 administered to each participant on 1 occasion |
| CORT125134 | EXPERIMENTAL | After an overnight fast, subjects will receive a single CORT125134 150-mg oral dose of the Phase 2 capsule formulation on Day 1. |
| SAD Cohorts 1 through 6 | EXPERIMENTAL | Participants will receive single doses of 5 mg up to 400 mg of CORT125134 (capsule) in a dose escalation format. The doses selected will be subject to amendment based on emerging data. |
| SAD Cohorts 1 through 6 Placebo | PLACEBO_COMPARATOR | Participants will receive single doses of Matching Placebo of CORT125134 (capsule). |
| Food Effect Cohort 7 | EXPERIMENTAL | Participants will receive a single dose of CORT125134 (capsule) with a standard high fat breakfast. The dose will be chosen such that it has been previously administered in a prior SAD cohort. |
| Pharmacological Effect Cohort 8 | EXPERIMENTAL | Participants will receive a single dose of 25 mg of prednisone on Day -19; a single dose of 25 mg prednisone and 600 mg of mifepristone on Day -12; and a single dose of 25 mg prednisone and a single dose of CORT125134 on Day 1. The dose of CORT125134 will be chosen such that it has been previously administered in a prior SAD cohort. |
| Proof of Concept (POC) Cohort 9 | EXPERIMENTAL | Participants will receive a single dose of 25 mg of prednisone on Day -19; a single dose of 25 mg of prednisone and 600 mg of mifepristone on Day -12; and a single dose of 25 mg prednisone and a single dose of CORT125134 on Day 1. An oral glucose tolerance test will be administered on each study day. The dose of CORT125134 will be chosen such that it has been previously administered in a prior SAD cohort. |
| MAD Cohorts 10 and 11 | EXPERIMENTAL | Participants will receive the selected dose of CORT125134 (capsule) following receipt of data from Cohorts 1-9 up to a maximum frequency of twice a day for a total of 14 days. |
| MAD Cohorts 10 and 11 Placebo | PLACEBO_COMPARATOR | Participants will receive Matching Placebo of CORT125134 (capsule) up to a maximum frequency of twice a day for a total of 14 days. |
| MAD of PoPE Cohorts 12 and 13 | EXPERIMENTAL | Proof of Pharmacological Effect (PoPE+POC). Participants will receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day -5. Participants will then receive the selected dose of CORT125134 (capsule) for a total of 13 days. Participants may either receive a higher dose level than previously administered or a repeat of a dose level given in 1 of the previous 2 MAD Cohorts. Participants will then receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day 14. |
| MAD of PoPE Cohort 12 and 13 Placebo | PLACEBO_COMPARATOR | Participants will receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day -5. Participants will then receive the Matching Placebo of CORT125134 (capsule) for a total of 13 days. Participants will then receive 25 mg of prednisone (both cohorts) and an oral glucose tolerance test (Cohort 13 only) on Day 14. |
| Name | Type | Description |
|---|---|---|
| CORT125134 | DRUG | - |
| CORT125134 150 mg | DRUG | CORT125134 150 mg (3 X 50 mg current capsule formulation) |
| CORT125134 250 mg | DRUG | CORT125134 250 mg (5 X 50 mg current capsule formulation) |
| CORT125134 dose to be determined | DRUG | CORT125134 current capsule formulation, dose to be determined |
| [14C]-CORT125134 | DRUG | - |
| Matching Placebo of CORT125134 | DRUG | Placebo |
| Mifepristone | DRUG | Active comparator |
| Prednisone | DRUG | Challenge agent |
| Glucose | DRUG | - |
Inclusion Criteria: 1. Has a confirmed diagnosis of endogenous Cushing's syndrome. 2. Requires medical treatment of hypercortisolemia. 3. Meets at least one of the following criteria: 1. Has type 2 diabetes mellitus. 2. Has impaired glucose tolerance. 3. Has hypertension. Exclusion Crite...
CORT125134 is an investigational small molecule being developed for Cushing's syndrome, a condition of excess cortisol. It has been studied in healthy volunteers in Phase 1 trials to evaluate its absorption, metabolism, and excretion. The drug is currently in Phase 2 development for Cushing's syndrome.
CORT125134 is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker CORT. The company is conducting clinical trials of CORT125134 in healthy subjects and for Cushing's syndrome.
CORT125134 is in Phase 2 clinical development for Cushing's syndrome. All four completed clinical trials listed for the drug were Phase 1 studies in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
CORT125134 has been studied in four completed Phase 1 trials. NCT03067376 examined its absorption and metabolism in 9 healthy adults in the UK. NCT03508635 was a single and multiple ascending dose study in 130 healthy subjects. NCT06094712 and NCT06094790 evaluated pharmacokinetics of different formulations in healthy subjects in the US.
No, CORT125134 is not the same as relacorilant. CORT125134 is a distinct investigational compound being developed by Corcept Therapeutics. While both are being studied for endocrine conditions, they are separate drug candidates with different chemical structures and clinical development programs.