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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Participants will receive a 100 mg single oral dose of casdatifan.
Research Site
San Antonio, Texas, United States
RECRUITINGArea under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
Time frame: Up to 10 days post-dose
Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf)
Time frame: Up to 10 days post-dose
Maximum observed concentration of casdatifan in plasma (Cmax)
Time frame: Up to 10 days post-dose
Time to reach Cmax of casdatifan in plasma (Tmax)
Time frame: Up to 10 days post-dose
Apparent first order terminal elimination rate constant calculated from a semi log plot of the plasma concentration versus time curve (Kel)
Time frame: Up to 10 days post-dose
Percent of AUC0-inf extrapolated (AUC%extrap)
Time frame: Up to 10 days post-dose
Apparent first order terminal elimination half life (t½)
Time frame: Up to 10 days post-dose
Apparent total clearance (CL/F)
Time frame: Up to 10 days post-dose
Apparent total clearance (Vz/F)
Time frame: Up to 10 days post-dose
Unbound fraction (fu) of casdatifan
Time frame: Up to 10 days post-dose
Number of participants experiencing Adverse Events (AEs)
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Time frame: Up to 23 days post-dose