Casdatifan pharmacokinetics in moderate hepatic impairment vs normal liver function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first‑in‑human pharmacokinetic study compares the single‑dose behavior of casdatifan between adults with moderate hepatic impairment and matched healthy controls. Participants receive a single dose of casdatifan and undergo PK sampling to characterize absorption, distribution, metabolism, and excretion. The study uses Child-Pugh class B criteria to define hepatic impairment and matches control participants on baseline characteristics. Safety, tolerability, and key laboratory and vital signs are monitored throughout the study. Location is a single research site in San Antonio, Texas, sponsored by Arcus Biosciences.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Medical Director
• Email: ClinicalTrialInquiry@arcusbio.com
• Phone: +1-510-462-3330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.