The overall goal of this Fast-Track application is to develop a therapeutic agent for the treatment of diabetic gastroparesis that can be used effectively several times a day with meals to avoid the discomfort associated with slow emptying of stomach contents. Because this agent addresses a symptom rather than the underlying disease itself, it is important for the drug to maintain efficacy throughout the chronic administration required for successful treatment. The clinical candidate selected in Phase I of this research will be advanced toward human clinical trials in Phase II. The overall objectives of the Phase II portion of the application are the demonstration of in vivo efficacy upon repeat dosing in a dog gastric emptying model and the execution of all studies required for the completion of a well-supported investigational new drug application (IND) to the Food and Drug Administration.
