NCT06919991

Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)

A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Casdatifan With Itraconazole (Strong CYP3A4 Inhibitor) and Phenytoin (Strong CYP3A4 Inducer) in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Arcus Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-05-02
• Primary completion: 2025-10-18
• Completion: 2025-10-18
• First posted: 2025-04-09
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study