Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

Phase 1/2 Completed 41 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.

Timeline

Start: 2008-12
Primary completion: 2009-07
Completion: 2009-07

Publications

Results Lalezari J, Asmuth D, Casiro A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2012 Dec;56(12):6372-8. doi: 10.1128/AAC.01521-12. Epub 2012 Oct 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IDX184	Other / unclassified	25 mg	Oral
Subject	IDX184	Other / unclassified	50 mg	Oral
Subject	IDX184	Other / unclassified	75 mg	Oral
Subject	IDX184	Other / unclassified	100 mg	Oral

Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

Summary

Timeline

Publications

Drugs

Indications