drugset / Trial / NCT02296905

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

NCT02296905

Phase 1 Completed 24 enrolled AbbVie
Non-randomizedParallel-groupOpen-labelBasic science

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).

Timeline

Start
2014-10
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject glecaprevir Other / unclassified Oral
Subject pibrentasvir Other / unclassified Oral

Indications

No indication recorded.