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This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of dazucorilant in healthy adults.
Participants in this study will complete screening assessments within 28 days before the first dose of study drug. Those participants who can participate will be admitted to the clinical pharmacology center (CPC) and complete pretreatment tests. Those participants will stay at the CPC for the duration of the study. On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, after eating. On Days 5-11, all participants will receive once daily, oral doses of itraconazole 200 mg, after eating. Blood and safety assessments will continue for 96-hours after dosing on Day 1 and Day 8. Participants will leave the CPC following completion of all procedures on Day 12.
Participants will return to the CPC for a final visit 7 (±1) days after their final dose of study medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dazucorilant (300 mg) and itraconazole (200 mg) | Experimental | On Days 1 and 8, each participant will receive a single oral dose of dazucorilant 300 mg, in a fed state. On Days 5-11, all participants will be administered once daily, oral doses of itraconazole 200 mg, in a fed state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dazucorilant | Drug | 75 mg soft gelatin capsules formulation for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of dazucorilant | Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8 | |
| Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) of plasma dazucorilant | Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8 | |
| Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf) of plasma dazucorilant | Predose and at serial timepoints up to 96 hours after dazucorilant dosing on Days 1 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with 1 or More Adverse Events | Up to Day 18 | |
| Number of Participants with 1 or More Clinically Significant Abnormal ECG Result | Up to Day 18 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Custodio, PhD | Corcept Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| C000623379 | CORT113176 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | 100 mg capsules for oral administration |
|
| Number of Participants with 1 or More Clinically Significant Abnormal Vital Signs |
| Up to Day 18 |
| Number of Participants with 1 or More Clinically Significant Abnormal Physical Examination Finding | Up to Day 18 |
| Number of Participants with 1 or More Clinically Significant Abnormal Clinical Laboratory Test Result | Up to Day 18 |
| D010879 |
| Piperazines |