Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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).
Key facts
- Study ID
- NCT02296905
- Run by
- AbbVie
- People needed
- 24
- Starts
- 2014-10-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2015-10-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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