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

Detailed criteria

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

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

Location

Research Site
San Antonio, Texas

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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