Recruiting
Phase 1

Casdatifan

Sponsor:

Arcus Biosciences, Inc.

Code:

NCT07751250

Conditions

Healthy Participants

Hepatic Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Casdatifan

Study Details

Brief summary:

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.

Conditions

Healthy Participants

Hepatic Impairment

Study ID

NCT07751250

Start date

Aug 14, 2026

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

All Participants:

  • Male participants must be vasectomized
  • BMI ≥ 18.0 and ≤ 42.0 kg/m2 and body weight ≥ 45 kg at screening.

Participants with Moderate HI (Group 1)

  • Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) at screening.
  • Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at screening

Healthy Participants:

  • Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee

Exclusion Criteria:

All Participants:

  • Participants with Gilbert's syndrome.

Participants with Moderate HI (Group 1):

  • Positive for HBsAg or HCV Ab, and detectable viral load at screening.
  • Severe complications of liver disease within the preceding 3 months of screening.
  • Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing, in the opinion of the PI or designee.

Healthy Control Participants:

  • History or presence of clinically significant medical or psychiatric condition or disease, or presence of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Casdatifan

Participants will receive a 100 mg single oral dose of casdatifan.

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 ]
  • Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf) [ Time Frame: Up to 10 days post-dose ]
  • Maximum observed concentration of casdatifan in plasma (Cmax) [ Time Frame: Up to 10 days post-dose ]

Central Contacts and Locations

Central contacts

Medical Director

+1-510-462-3330ClinicalTrialInquiry@arcusbio.com

Locations

Research Site

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Arcus Biosciences, Inc.

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Keywords

  • Casdatifan
  • AB521
  • HIF-2α
  • Pharmacokinetics
  • Hepatic Impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Arcus Biosciences, Inc. on 2026-09-04.