Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-84
SponsorArcus Biosciences, Inc.

About this trial

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 criteria

Qualifiers

Male participants must be vasectomized

BMI ≥ 18.0 and ≤ 42.0 kg/m2 and body weight ≥ 45 kg at screening.

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

Disqualifiers

Participants with Gilbert's syndrome.

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.

Trial design

Treatments tested in this trial

  • Casdatifan

Treatment groups

16 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators