The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
IDX719 supplied as 50 mg tablets.
Maximum plasma concentration (Cmax)
Time frame: Up to 6 days
Time to maximum plasma concentration (Tmax)
Time frame: Up to 6 days
Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)
Time frame: Up to 6 days
AUC from time zero to infinity (AUC0-~)
Time frame: Up to 6 days
AUC from time zero to 24 hours (AUC0-24h)
Time frame: Up to 6 days
Plasma concentration 24 hours after dosing (C24h)
Time frame: Up to 6 days
Apparent terminal elimination rate constant
Time frame: Up to 6 days
Observed terminal half-life (T1/2)
Time frame: Up to 6 days
Percentage of participants experiencing serious adverse events (SAEs)
Time frame: Up to 6 days
Percentage of participants experiencing an adverse event (AE)
Time frame: Up to 6 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
Time frame: Up to 6 days
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