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The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan tablet versus the casdatifan capsule, and to evaluate the effect of food on the single-dose PK of casdatifan tablet in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Casdatifan - Sequence ABC | Experimental | Participants will sequentially receive casdatifan capsules fasted (Treatment A), followed by casdatifan tablets fasted (Treatment B), followed by casdatifan tablets fed (Treatment C) |
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| Casdatifan - Sequence BCA | Experimental | Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A |
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| Casdatifan - Sequence CAB | Experimental | Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| casdatifan | Drug | Administered as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Drug Concentration-Time Curve (AUC) | Predose, Up to 168 hours postdose | |
| Maximum Concentration (Cmax) | Predose, Up to 168 hours postdose | |
| Time to Maximum Concentration (Tmax) | Predose, Up to 168 hours postdose | |
| Terminal Half-Life Time (t1/2) | Predose, Up to 168 hours postdose | |
| Apparent Total Plasma Clearance (CL/F) | Predose, Up to 168 hours postdose | |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) | Predose, Up to 168 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Up to 10 weeks |
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Key Inclusion Criteria:
Key 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, Inc. | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Description ARC-28 - Public website | View source |
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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.
For more information, please visit our website.
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