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The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong CYP3A4 inducer) on single dose PK of casdatifan in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Casdatifan-Itraconazole-Phenytoin | Experimental | Participants will receive casdatifan, itraconazole, and phenytoin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casdatifan | Drug | Administered as a single dose in treatment Periods 1, 2, and 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan | Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3 | |
| Maximum Concentration (Cmax) in Plasma for casdatifan | Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3 | |
| Time to Maximum Concentration (Tmax) in Plasma for casdatifan | Up to 168 hours post dose for Period 1; up to 216 hours post dose for Period 2; and up to 120 hours post dose for Period 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 26.2 weeks | |
| Concentration observed at the end of the dosing interval (Ctrough) for itraconazole (Period 2) and phenytoin (Period 3) | Up to 18 days |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Arcus Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Administered as multiple doses in treatment Period 2 |
|
| Phenytoin | Drug | Administered as multiple doses in treatment Period 3 |
|
| D010879 |
| Piperazines |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |