Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)

Phase 1 Completed 48 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to obtain single dose safety and pharmacokinetic (PK) data of IDX184 in humans. No formal hypotheses are to be tested in this study.

Timeline

Start: 2008-07
Primary completion: 2008-10
Completion: 2008-10

Publications

Results Zhou XJ, Pietropaolo K, Chen J, Khan S, Sullivan-Bolyai J, Mayers D. Safety and pharmacokinetics of IDX184, a liver-targeted nucleotide polymerase inhibitor of hepatitis C virus, in healthy subjects. Antimicrob Agents Chemother. 2011 Jan;55(1):76-81. doi: 10.1128/AAC.01101-10. Epub 2010 Nov 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IDX184	Other / unclassified	5 mg	Oral
Subject	IDX184	Other / unclassified	10 mg	Oral
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

Single-Dose Escalation Study of IDX184 in Healthy Volunteers (MK-2355-002)

Summary

Timeline

Publications

Drugs

Indications