NCT02442258

Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function

Evaluation of the Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single dose study designed to assess the pharmacokinetics and safety of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal function.

Detailed description

Up to 48 subjects will be selected and enrolled according to the subject selection criteria: 8 subjects with mild renal impairment (Group 1), 8 subjects with moderate renal impairment (Group 2), 8 subjects with severe renal impairment (Group 3), 8 subjects with end stage renal disease that are not yet on dialysis (Group 4), 8 healthy subjects with normal renal function (Group 5), and 8 subjects with end stage renal disease on hemodialysis (Group 6).

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	ABT-493	A single dose of ABT-493 will be given orally in combination with ABT-530.
DRUG	ABT-530	A single dose of ABT-530 will be given orally in combination with ABT-493.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-05-13
• Last updated: 2016-02-22

Locations

3 sites across 2 countries: United States, New Zealand