737 a Phase-i, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Oral Doses of Gs-9620 in Healthy Subjects

Content Provider	Semantic Scholar
Author	Lopatin, Uri Wolfgang, Grushenka H. I. Kimberlin, Richard H. Turnas, Dan Cornprost, M. Chittick, Greg Frey, Christian R. Findlay, Janice Ohmstede, Carol Kearney, Brian P. Barnes, Charles McHutchinson, John G. Hirsch, K.
Copyright Year	2011
Abstract	GS-9620 is a potent, oral small molecule agonist of TLR-7, which was safe and • well tolerated in single ascending doses up to 12 mg PO Preliminary PK data suggest GS-9620 reached C • max between 1.5 hours and 6.0 hours after dosing and had approximately dose-proportional trends in Cmax and AUCinf Pharmacodynamic effects are seen in ISG, cytokines, and hematologic • responses, beginning at 2 mg PO ─ These fi ndings confi rm the preclinical data suggesting that GS-9620 induces multiple cytokines (including Interferon) pre-systemically, with the potential for decreased adverse events compared to systemic pegylated interferon GS-9620 is a promising, oral immunomodulatory agent with potency in the low • milligram range and a therapeutic window which supports further evaluation in the therapy of viral hepatitis B and C 46th Annual Meeting of the European Association for the Study of the Liver March 30 April 3, 2011 Berlin, Germany
File Format	PDF HTM / HTML
DOI	10.1016/S0168-8278(11)60739-3
Alternate Webpage(s)	http://www.hivandhepatitis.com/2011_conference/easl2011/posters/lopatin.pdf
Alternate Webpage(s)	https://doi.org/10.1016/S0168-8278%2811%2960739-3
Volume Number	54
Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article