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

Phase 1 Completed 46 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 ABT-530 in subjects with either normal renal function or impaired renal function.

Timeline

Start: 2015-03
Primary completion: 2015-12
Completion: 2015-12

Publications

Kosloski MP, Zhao W, Marbury TC, Preston RA, Collins MG, Pugatch D, Mensa F, Kort J, Liu W. Effects of Renal Impairment and Hemodialysis on the Pharmacokinetics and Safety of the Glecaprevir and Pibrentasvir Combination in Hepatitis C Virus-Negative Subjects. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e01990-17. doi: 10.1128/AAC.01990-17. Print 2018 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	glecaprevir	Other / unclassified	300 mg	Oral
Subject	pibrentasvir	Other / unclassified	120 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications