Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 84 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Moderate Hepatic Impairment
Administered as specified in the treatment arm.
  • Drug: Casdatifan
    Participants will receive a 100 mg single oral dose of casdatifan.
Experimental
Group 2: Healthy Control Participants
Administered as specified in the treatment arm.
  • Drug: Casdatifan
    Participants will receive a 100 mg single oral dose of casdatifan.

Recruiting Locations

Research Site
San Antonio, Texas 78215

More Details

Status
Recruiting
Sponsor
Arcus Biosciences, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.