Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-01 @ 1:29 AM
Study NCT ID:
NCT02296905
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
Pharmacokinetics and Safety of ABT-493 and/or ABT-530 in Subjects With Normal and Impaired Hepatic Function
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: