Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function

Study Identifier
M13-604
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact
Study Complete

Study Details

Medical Condition
  • Liver, Pancreas & Gallbladder - Other
  • Study Drug
  • ABT-493
  • ABT-530
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 130589
    Miami, Florida, United States, 33136
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 130591
    Orlando, Florida, United States, 32809
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 130588
    San Antonio, Texas, United States, 78215
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 130590
    Grafton, New Zealand, 1010
    Status
    Not applicable