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This study will compare the pharmacokinetics (PK) of dazucorilant (CORT113176) between participants with normal hepatic function and participants with hepatic impairment.
Initially, participants with moderate hepatic impairment and healthy control participants matched as to gender, age, and weight will be enrolled. After completing screening assessments, participants will receive a single dose of dazucorilant followed by an observation period of 7 days. Based on the observed effect of moderate hepatic impairment on the dazucorilant PK profile, and review of safety data, a group of participants with mild hepatic impairment, matched to the enrolled healthy control participants, may be enrolled to evaluate the effects of mild hepatic impairment on dazucorilant PK.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hepatic Impairment | Experimental | On Day 1, each participant with moderate hepatic impairment will receive a single oral dose of dazucorilant 300 mg. |
|
| Matched Healthy Participants | Experimental | Healthy participants will be matched to those with moderate hepatic impairment as to gender, age (± 10 years of the mean), and weight (± 20% of the mean). On Day 1, each healthy participant will receive a single oral dose of dazucorilant 300 mg. |
|
| Mild Hepatic Impairment | Experimental | On Day 1, each participant with mild hepatic impairment will receive a single oral dose of dazucorilant 300 mg. This arm may be enrolled after review of interim PK evaluation of the effects of moderate hepatic impairment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dazucorilant | Drug | Dazucorilant 300 mg (4 X 75 mg) soft gelatin capsules for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to the last non-zero concentration (AUC0-t) of dazucorilant | Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing | |
| Area under the concentration-time curve from time zero to infinity (extrapolated) (AUC0-inf) of dazucorilant | Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing | |
| Maximum observed concentration (Cmax) of dazucorilant | Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing | |
| Time to maximum concentration (Tmax) of dazucorilant | Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing | |
| Apparent clearance (Cl/F) of dazucorilant | Predose and at serial timepoints up to 24 hours after dosing, and at 48, 72, 96, 120, and 144 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with 1 or more adverse events | Up to Day 7 | |
| Number of participants with 1 or more clinically significant abnormal vital signs | Up to Day 7 | |
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Inclusion Criteria:
Additional Inclusion Criteria for Healthy Control Group Participants Only:
Additional Inclusion Criteria for Participants with Hepatic Impairment Only:
Exclusion Criteria:
Additional Exclusion Criteria for Healthy Control Group Participants Only:
Additional Exclusion Criteria for Participants with Hepatic Impairment Only:
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| Name | Affiliation | Role |
|---|---|---|
| Jeevan Kunta, PhD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2 | Rialto | California | 92377 | United States | ||
| Site 1 |
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| ID | Term |
|---|---|
| C000623379 | CORT113176 |
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| Number of participants with 1 or more clinically significant abnormal electrocardiogram (ECG) result |
| Up to Day 7 |
| Number of participants with 1 or more clinically significant abnormal clinical laboratory result | Up to Day 7 |
| Number of participants with 1 or more clinically significant abnormal physical examination result | Up to Day 7 |
| Miami |
| Florida |
| 33014 |
| United States |