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A study designed to characterize the plasma pharmacokinetic (PK) profile of CORT125134 in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134 for 14 days.
Initially, subjects will be enrolled into 2 cohorts each of 8 subjects (Cohort 1 and Cohort 2) to receive CORT125134 at 150 mg or 250 mg, respectively. Data from Cohorts 1 and 2 will be evaluated to select dose levels for Cohort 3 and optional Cohort 4.
The secondary objective of the study is to characterize the plasma PK profile of CORT125134 metabolites in healthy subjects receiving once-daily oral administration of the current capsule formulation of CORT125134.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects will receive CORT125134 150 mg once daily for 14 days |
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| Cohort 2 | Experimental | Subjects will receive CORT125134 250 mg once daily for 14 days |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORT125134 150 mg | Drug | CORT125134 150 mg (3 X 50 mg current capsule formulation) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve over a dose-interval of plasma CORT125134 (AUCtau) | Predose and at serial timepoints over a dose-interval following dosing on Days 1, 7, and 14 | |
| Maximum concentration of plasma CORT125134 (Cmax) | Predose and at serial timepoints up to 24 hours following Day 1 and Day 7 dosing, and at serial timepoints up to 120 hours following Day 14 dosing | |
| AUC from the time of dosing until 24 hours later of plasma CORT125134 (AUC0-24h) | 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. | Predose and at serial timepoints up to 24 hours following dosing on Days 1, 7, and 14. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Moraitis | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences, Miami, Inc. | Miami | Florida | 33126 | United States |
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| ID | Term |
|---|---|
| C000633444 | relacorilant |
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| CORT125134 250 mg |
| Drug |
CORT125134 250 mg (5 X 50 mg current capsule formulation) |
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| CORT125134 dose to be determined | Drug | CORT125134 current capsule formulation, dose to be determined |
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