This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Oral single dose 10 mg
DaVita Clinical Research
Lakewood, Colorado, United States
Orlando Clinical Research Center
Orlando, Florida, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Vrg & Noccr
Knoxville, Tennessee, United States
Maximum plasma concentration (Cmax)
Time frame: 5 days
Time to reach maximum concentration (Tmax)
Time frame: 5 days
Area under of the curve (AUC0-t and AUC0-∞)
Time frame: 5 days
Elimination of half-life (t1/2)
Time frame: 5 days
Apparent terminal elimination rate constant (λz)
Time frame: 5 days
Total body clearance (CL/F)
Time frame: 5 days
Volume of distribution (Vz/F)
Time frame: 5 days
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