BioCentury
ARTICLE | Clinical News

GKT137831: Additional Phase I data

November 12, 2012 8:00 AM UTC

Pooled data from 84 healthy male volunteers in a pair Phase I trials showed that single and multiple doses of oral GKT137831 were well tolerated with no dose-limiting toxicities (DLTs) or serious adverse events reported. The open-label Phase I trial evaluated single ascending-doses of 10-1,800 mg GKT137831 in 36 volunteers. The double-blind, placebo-controlled Phase I trial evaluated once-daily 100, 300 and 900 mg GKT137831 and twice-daily 400 mg GKT137831 in 48 volunteers. Data were presented at the American Society of Nephrology meeting in San Diego. ...