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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002456-36 | EudraCT Number |
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This is a safety, tolerability, and pharmacokinetic study in 2 cohorts of healthy male participants with an option for an additional cohort. Cohorts 1 and 2 will receive once daily by mouth CORT113176 150 mg and 300 mg, respectively, for 14 days under fed conditions. Progression from Cohort 1 to Cohort 2 will be done based on the safety and tolerability outcome in Cohort 1 and after Cohort 1 has received the study drug for at least 7 days. The optional Cohort 3 may receive a higher dose that will not exceed CORT113176 450 mg once daily by mouth for 14 days under fed conditions. The progression from Cohort 2 to the optional cohort (Cohort 3) will be based on the same precautions as with the progression from Cohort 1 to Cohort 2. Each participant will undergo safety evaluations. Pharmacokinetics of CORT113176 will be assessed in plasma and cerebrospinal fluid (CSF) samples. Pharmacodynamic assessments will include the measurement of serum cortisol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Cohort 1: Placebo matching CORT113176 | Placebo Comparator | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
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| 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. |
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| Cohort 2: Placebo matching CORT113176 | Placebo Comparator | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORT113176 | Drug | CORT113176 lipid capsule formulation for oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Adverse Events | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of CORT113176 | Before dosing and a pre-specified time points up to Day 17 | |
| Time of Cmax (Tmax) of Plasma CORT113176 | Before dosing and a pre-specified time points up to Day 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hazel Hunt, Ph.D. | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Groningen | 9728 NZ | Netherlands |
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| ID | Term |
|---|---|
| C000623379 | CORT113176 |
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| Cohort 3: Placebo matching CORT113176 | Placebo Comparator | Participants will receive placebo matching CORT113176 capsule by mouth once daily under fed conditions for 14 days. |
|
| Placebo matching CORT113176 | Drug | Placebo matching CORT113176 lipid capsule formulation for oral administration |
|
| Apparent Elimination Half-life (t1/2) of Plasma CORT113176 | Before dosing and a pre-specified time points up to Day 17 |
| Area Under the Plasma Concentration-time Curve (AUC) of Plasma CORT113176 | Before dosing and a pre-specified time points up to Day 17 |
| Cerebrospinal Fluid Concentration of CORT113176 | Approximately 3 and 5 hours after dosing on Day 7 |
| Serum Concentration of Cortisol | Before and approximately 12 hours after dosing on Days 1, 7, and 14 |