VPA-985 ADMINISTERED TO PATIENTS WITH LIVER CIRRHOSIS AND ASCITES

$0M01FY2000RRNIH

University Of Pennsylvania, Philadelphia PA

Investigators

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Abstract

This is a phase I, multicenter, randomized, double-blind (unblinded third-party), placebo-controlled, ascending, multiple-dose safety and tolerance inpatient study or oral doses of VPA-985 in patients with cirrhosis and ascites. Dose excalation to the next higher level proceed after the safety data from the previous dose level have been reviewed by the investigators and Wyeth-Ayerst Research (W-AR) medical monitor. The study will be conducted at up to six study centers. The primary objective is to evaluate the safety and tolerance of multiple oral doses of VPA-985 in patients with cirrhosis and ascites or a history of ascites. Secondary objectives are to obtain preliminary pharmacokinetic and pharmacocynamic information about the compound in this patient population.

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