This is an open-label, single-dose study designed to assess the pharmacokinetics and safety of ABT-493 and/or ABT-530 in subjects with impaired hepatic function and compare them to those in subjects with normal hepatic function. Twenty-four subjects will be selected and enrolled according to the subject selection criteria: 6 subjects with mild stable chronic hepatic impairment (Group I), 6 subjects with moderate stable chronic hepatic impairment (Group II), 6 subjects with severe stable chronic hepatic impairment (Group III) and 6 subjects with normal hepatic function (Group IV).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.
Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.
Site Reference ID/Investigator# 130589
Miami, Florida, United States
Site Reference ID/Investigator# 130591
Orlando, Florida, United States
Site Reference ID/Investigator# 130588
San Antonio, Texas, United States
Site Reference ID/Investigator# 130590
Grafton, New Zealand
Overall measurement of pharmacokinetic parameter values of ABT-493 and ABT-530
Pharmacokinetic parameter values include the maximum plasma concentration (Cmax), the terminal phase elimination rate constant (B), the area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
Time frame: 7 days
Overall measurement of safety parameters
Measurement of safety parameters include physical examinations, clinical laboratory tests, 12-lead ECGs (electrocardiograms) and vital signs.
Time frame: Up to 38 days
Number of subjects with adverse events
Time frame: Up to 58 days
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