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A study designed to characterize the pharmacokinetic (PK) profile of CORT125134 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.
Following an overnight fast, subjects will be administered a single 150-mg oral dose of CORT125134 capsules on the morning of Day 1. Blood samples for determination of PK parameters will be collected predose and at serial time points up to 120 hours after study drug administration. The secondary objective of the study is to characterize the PK profile of metabolite CORT125201 following a single 150-mg oral dose of the Phase 2 capsule formulation of CORT125134 in 8 healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORT125134 | Drug | CORT125134 150-mg capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of plasma CORT125134 (Cmax) | Predose and at serial time points up to 120 hours after dosing | |
| Time of maximum concentration of plasma CORT125134 (Tmax) | Predose and at serial time points up to 120 hours after dosing | |
| Area under the concentration-time curve from time zero to the time of last measurable concentration of plasma CORT125134 (AUC0-last) | Predose and at serial time points up to 120 hours after dosing | |
| Area under the concentration-time curve from time zero extrapolated to infinity of plasma CORT125134 (AUC0-inf) | Predose and at serial time points up to 120 hours after dosing | |
| Apparent terminal half-life of plasma CORT125134 (T1/2) | Predose and at serial time points up to 120 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hazel Hunt | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic | Kalamazoo | Michigan | 49007 | United States |
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| ID | Term |
|---|---|
| C000633444 | relacorilant |
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