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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06094790 | A Study to Evaluate the Pharmacokinetics of the Current Capsule Formulation of CORT125134 in Healthy Subjects | PHASE1 | COMPLETED | 32 | — | — | May 18, 2017 | Nov 15, 2017 | Oct 23, 2023 | 1 | United States |
| NCT03067376 | A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body | PHASE1 | COMPLETED | 9 | — | — | Aug 1, 2016 | Sep 1, 2016 | Aug 9, 2019 | 1 | United Kingdom |
| NCT06094712 | A Study to Evaluate the Pharmacokinetics of the CORT125134 Phase 2 Formulation in Healthy Male Subjects | PHASE1 | COMPLETED | 8 | — | — | Apr 7, 2016 | Apr 27, 2016 | Oct 23, 2023 | 1 | United States |
| NCT03508635 | CORT125134 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) | PHASE1 | COMPLETED | 130 | — | — | Sep 1, 2014 | Dec 1, 2015 | Aug 9, 2019 | 1 | United Kingdom |
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 |
|---|---|---|
| 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 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 | - |
| CORT125134 | DRUG | CORT125134 150-mg capsule |
| Matching Placebo of CORT125134 | DRUG | Placebo |
| Mifepristone | DRUG | Active comparator |
| Prednisone | DRUG | Challenge agent |
| Glucose | DRUG | - |
Inclusion Criteria: * Give written informed consent * Be healthy males or non-pregnant, non-lactating healthy females * Must agree to use an adequate method of contraception as described in the study protocol * Have a body mass index (BMI) of 18 to 32 kg/m\^2, inclusive and body weight more than 50...