A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to Healthy Matched Participants
Arcus Biosciences, Inc.
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.
Eligibility
- Age range
- 18–84 years
- Sex
- All
- 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 e…
Interventions
- DrugCasdatifan
Participants will receive a 100 mg single oral dose of casdatifan.
Location
- Research SiteSan Antonio, Texas