Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Arcus Biosciences, Inc.
Study ID
NCT07751250
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Participants
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Accepted

Interventions

  • Casdatifan — DRUG
    Participants will receive a 100 mg single oral dose of casdatifan.

Study Details

The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 14, 2026
Status verified
Aug 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1: Moderate Hepatic Impairment
    Administered as specified in the treatment arm.
  • Experimental: Group 2: Healthy Control Participants
    Administered as specified in the treatment arm.

Primary Outcome Measure

Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t) [ Time Frame: Up to 10 days post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteSan AntonioTexas78215-

Related Studies