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The primary objective of this multiple-dose, adaptive design study is to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of relacorilant relative to healthy matched control male and female subjects (Part 1).
If an obvious effect of moderate hepatic impairment on exposure to relacorilant is observed in Part 1, optional Part 2 of the study will be conducted. In Part 2, the effect of mild hepatic impairment on the PK of relacorilant will be evaluated, using control data from the same healthy control subjects who were matched to the subjects in Part 1.
Secondary objectives of the study are 1) evaluation of the effect of hepatic impairment on the PK of relacorilant metabolites, and 2) evaluation of safety and tolerability of relacorilant on healthy subjects and those with hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Hepatic Impairment | Experimental | Subjects with no hepatic impairment will receive relacorilant 300 mg once daily on Days 1 through 10. |
|
| Moderate Hepatic Impairment | Experimental | Subjects with moderate hepatic impairment (Child-Pugh Class B) will receive relacorilant 300 mg once daily on Days 1 through 10. |
|
| Mild Hepatic Impairment | Experimental | Subjects with mild hepatic impairment (Child-Pugh Class A) will receive relacorilant 300 mg once daily on Days 1 through 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relacorilant | Drug | Relacorilant 300 mg (3 X 100 mg softgel capsules) for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of plasma relacorilant during the dosing interval (Cmax) | Predose and at serial time points up to 24 hours after dosing on Day 10 | |
| Area under the concentration-time curve of plasma relacorilant from time zero to the end of the dosing interval (24 hours) (AUCt) | Predose and at serial time points up to 24 hours after dosing on Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of relacorilant plasma metabolites | Predose and at serial time points up to 24 hours after dosing on Day 10 | |
| AUCt of relacorilant plasma metabolites | Predose and at serial time points up to 24 hours after dosing on Day 10 |
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Inclusion Criteria:
Subjects with normal hepatic function must also satisfy the following inclusion criteria:
Subjects with moderate or mild hepatic impairment must also satisfy the following inclusion criteria:
Exclusion Criteria:
Additional exclusion criteria for subjects with moderate or mild hepatic impairment:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Custodio | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC | Miami | Florida | 33014 | United States | ||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| C000633444 | relacorilant |
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|
| Number of subjects with one or more treatment-emergent adverse events | Up to Day 20 |
| Number of subjects with one or more treatment-emergent adverse events by severity | Up to Day 20 |
| Orlando |
| Florida |
| 32809 |
| United States |