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 — DRUG
    Administered as a single dose in treatment Periods 1, 2, and 3
  • Itraconazole — DRUG
    Administered as multiple doses in treatment Period 2
  • Phenytoin — DRUG
    Administered 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

First listed
Apr 9, 2025
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-Phenytoin
    Participants 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)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZ

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