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.
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
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.
Parallel
Casdatifan
DrugParticipants will receive a 100 mg single oral dose of casdatifan.
Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf)
Maximum observed concentration of casdatifan in plasma (Cmax)
Time to reach Cmax of casdatifan in plasma (Tmax)
Apparent first order terminal elimination rate constant calculated from a semi log plot of the plasma concentration versus time curve (Kel)
Percent of AUC0-inf extrapolated (AUC%extrap)
Apparent first order terminal elimination half life (t½)
Click on the lead sponsor to view all of their trials.
