The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Seladelpar 10 mg single oral dose
Seladelpar 10 mg or less, once daily for 28 days
Arizona Liver Health
Chandler, Arizona, United States
University of California Davis
Evaluate maximum concentration (Cmax) of seladelpar and metabolites
Time frame: 17 weeks
Evaluate the time to reach Cmax (Tmax) of seladelpar and metabolites
Time frame: 17 weeks
Evaluate area under the concentration curve versus time curve of seladelpar and metabolites
Time frame: 17 weeks
Evaluate the amount of seladelpar excreted in the urine (Ae)
Time frame: 17 weeks
Evaluate safety and tolerability as assessed by the incidence of treatment emergent adverse events and serious treatment emergent adverse events across child pugh treatment groups
Time frame: 17 weeks
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American Research Corporation
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