Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

Phase 2 Completed 81 enrolled Merck Sharp & Dohme LLC

RandomizedFactorialQuadruple-blindTreatment

Summary

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.

Timeline

Start: 2009-11
Primary completion: 2010-07
Completion: 2010-07

Publications

Results Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. IDX184 in combination with pegylated interferon-alpha2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2013;18(6):755-64. doi: 10.3851/IMP2552. Epub 2013 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IDX184	Other / unclassified	50 mg	Oral
Subject	IDX184	Other / unclassified	100 mg	Oral
Subject	IDX184	Other / unclassified	150 mg	Oral
Subject	IDX184	Other / unclassified	200 mg	Oral
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	—
Background	Ribavirin	Small molecule	1000 mg	—
Background	Ribavirin	Small molecule	1200 mg	—

Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

Summary

Timeline

Publications

Drugs

Indications