Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)

Phase 2 Completed 140 enrolled Gilead Sciences

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.

Timeline

Start: 2012-11
Primary completion: 2013-06
Completion: 2013-06

Outcome

Met primary endpoint

paper active treatment was associated with a lower viral load (adjusted mean, 250.7 vs. 757.7 log10 plaque-forming-unit equivalents [PFUe] × hours per milliliter; P<0.001) PMID 25140957 ↗

release “The study of GS-5806, an investigational oral RSV fusion inhibitor, achieved its primary and secondary endpoints” gilead.com ↗

Publications

DeVincenzo JP, Whitley RJ, Mackman RL, Scaglioni-Weinlich C, Harrison L, Farrell E, McBride S, Lambkin-Williams R, Jordan R, Xin Y, Ramanathan S, O'Riordan T, Lewis SA, Li X, Toback SL, Lin SL, Chien JW. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014 Aug 21;371(8):711-22. doi: 10.1056/NEJMoa1401184.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Presatovir	Small molecule	5 mg	Oral
Subject	Presatovir	Small molecule	25 mg	Oral
Subject	Presatovir	Small molecule	100 mg	Oral