A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Arcus Biosciences, Inc.
Study ID
NCT07641881
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Casdatifan — DRUG
    Administered as specified in the treatment arm

Study Details

The purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan 100 mg versus four 25 mg tablets under fasting conditions in healthy adult participants, and to evaluate the effect of food on the single-dose PK of casdatifan 100 mg administered as four 25 mg tablets in healthy adult participants.

Key Dates

First listed
Jun 11, 2026
Start date
May 29, 2026
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A
    Participants will receive 4 X 25 mg tablets of casdatifan.
  • Experimental: Treatment B
    Participants will receive 1 X 100 mg tablets of casdatifan.
  • Experimental: Treatment C
    Participants will receive 4 X 25 mg tablets of casdatifan under fed conditions.

Primary Outcome Measure

Maximum observed concentration for casdatifan [ Time Frame: Up to 168 hours post each dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteTempeArizona85283-

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