This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. The study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose.
Study Type
INTERVENTIONAL
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Oral tablet
Prism Clinical Research
Saint Paul, Minnesota, United States
American Research Corporation at the University of Texas Liver Institute
San Antonio, Texas, United States
Area under the concentration-time curve from dosing to last measurable concentration (AUClast)
Time frame: Day 1, Day 4
Area under the concentration-time curve from dosing to infinity (AUCinf)
Time frame: Day 1, Day 4
Observed maximum concentration (Cmax).
Time frame: Day 1, Day 4
Time to reach Cmax of vadadustat
Time frame: Day 1, Day 4
Apparent total body clearance (CL/F) of vadadustat
Time frame: Day 1, Day 4
Apparent volume of distribution (Vd/F) of vadadustat
Time frame: Day 1, Day 4
Terminal half-life (t1/2) of vadadustat
Time frame: Day 1, Day 4
Time to reach Tmax of vadadustat
Time frame: Day 1, Day 4
Assessment of Treatment-Emergent Adverse Events (TEAEs) as reported by study subjects
Time frame: Up to 9 Weeks
Cmax related to free drug (Cmax, free) of Vadadustat Unbound
Time frame: Day 1, Day 4
AUClast related to free drug (AUClast, free) of Vadadustat Unbound
Time frame: Day 1, Day 4
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AUCinf related to free drug (AUCinf, free) of Vadadustat Unbound
Time frame: Day 1, Day 4
CL/F related to free drug (CL/Ffree) of Vadadustat Unbound
Time frame: Day 1, Day 4
Terminal half-life (t1/2) of Vadadustat Unbound
Time frame: Day 1, Day 4
The area under the concentration-time curve from dosing to last measurable concentration (AUClast) of Vadadustat metabolites
Time frame: Day 1, Day 4
The area under the concentration-time curve from dosing to infinity (AUCinf) of Vadadustat metabolite
Time frame: Day 1, Day 4
Time to reach Cmax of vadadustat metabolites
Time frame: Day 1, Day 4
Terminal half-life (t1/2) of Vadadustat metabolites
Time frame: Day 1, Day 4
Renal clearance (CLr) of Vadadustat/metabolite(s) Urine
Time frame: Day 1, Day 4
Cumulative amount of drug excreted (Ae) of Vadadustat/metabolite(s) Urine
Time frame: Day 1, Day 4
Cumulative fraction of drug excreted (Fe) of Vadadustat/metabolite(s) Urine
Time frame: Day 1, Day 4