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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.
Full description
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.
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Inclusion and exclusion criteria
Inclusion Criteria (All groups):
Additional Group-Specific Inclusion Criteria:
Group 1 (Moderate Hepatic Impairment Subjects):
Group 2 (Normal Hepatic Function Subjects):
Group 3 (Mild Hepatic Impairment Subjects):
Exclusion Criteria (all groups):
24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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