EFFECT OF FOOD ON BIOAVAILABILITY OF ERL 080A

$0M01FY2000RRNIH

Columbia University Health Sciences, New York NY

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Abstract

This study is being conducted to determine the effect of food on the absorption of ERL080. ERL080 is similar to a drug (Cellcept) that is already in use in transplant patients to prevent organ rejection. A significant percentage of patients are unable to tolerate Cellcept because of nausea, vomiting and other gastrointestinal side effects. ERL080 is enteric coated and potentially could reduce these side effects. The effect of food on the absorption of ERL080A is unknown and this study is designed to answer this question. 12 adult patients with kidney transplants that have been stable for over a year and who are on Cellcept will be eligible. The primary goal is to observe the difference between fed and fasting state on the absorption of ERL080A. The secondary objective is to observe the safety and tolerability of a single dose of ERL080A in the fed and fasting conditions.

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