Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)
Part of paid clinical trials in Tempe, Arizona.
- Sponsor
- Arcus Biosciences, Inc.
- Study ID
- NCT06919991
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Participants
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Casdatifan — DRUGAdministered as a single dose in treatment Periods 1, 2, and 3
- Itraconazole — DRUGAdministered as multiple doses in treatment Period 2
- Phenytoin — DRUGAdministered as multiple doses in treatment Period 3
Study Details
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.
Key Dates
- Start date
- May 2, 2025
- Status verified
- Apr 2025
- Primary completion
- Oct 18, 2025
- Completion
- Oct 18, 2025
Study Design
- Enrollment
- 14 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Casdatifan-Itraconazole-PhenytoinParticipants will receive casdatifan, itraconazole, and phenytoin.
Primary Outcome Measure
Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan [ Time Frame: 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 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | - |
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