NCT02296905

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	ABT-493	Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.
DRUG	ABT-530	Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-11-21
• Last updated: 2015-10-21

Locations

4 sites across 2 countries: United States, New Zealand