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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04994743 | Safety, Tolerability, and Pharmacokinetic Study of CORT113176 in Healthy Participants | PHASE1 | COMPLETED | 16 | — | — | Jul 13, 2021 | Sep 30, 2021 | Oct 11, 2021 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| Cohort 1: CORT113176 150 mg | EXPERIMENTAL | Participants will receive CORT113176 150 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. |
| Cohort 1: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Cohort 2: CORT113176 300 mg | EXPERIMENTAL | Participants will receive CORT113176 300 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Progression from Cohort 1 to 2 will be done based on safety and tolerability outcome from Cohort 1 and only after Cohort 1 has received study drug for ≥7 days. |
| Cohort 2: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Cohort 3: CORT113176 ≥300 mg | EXPERIMENTAL | Participants will receive CORT113176 ≥300 mg not to exceed 450 mg lipid capsule formulation by mouth once daily under fed conditions for 14 days. Cohort 3 is optional, and progression from Cohort 2 to 3 be done based on safety and tolerability outcome from Cohort 2 and only after Cohort 2 has received study drug for ≥7 days. |
| Cohort 3: Placebo matching CORT113176 | PLACEBO_COMPARATOR | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
| Name | Type | Description |
|---|---|---|
| CORT113176 | DRUG | CORT113176 lipid capsule formulation for oral administration |
| Placebo matching CORT113176 | DRUG | Placebo matching CORT113176 lipid capsule formulation for oral administration |
Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kg/m\^2, inclusive * Body weight ≤100 kg. * Must agree to adhere to the requirements on contraception, exposure to sexual partners, and sperm donation as defined in the protocol * Additional criteria apply. Exclusion Criteria: * Received...