Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)
NCT06919991 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2025-11-13
Summary
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.
Conditions
- Healthy Participants
Interventions
- DRUG
-
Casdatifan
Administered as a single dose in treatment Periods 1, 2, and 3
- DRUG
-
Itraconazole
Administered as multiple doses in treatment Period 2
- DRUG
-
Phenytoin
Administered as multiple doses in treatment Period 3
Sponsors & Collaborators
-
Arcus Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Arcus Biosciences
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-02
- Primary Completion
- 2025-10-18
- Completion
- 2025-10-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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