Motilin Receptor Agonists for Diabetic Gastroperesis

描述（由申请人提供）：该快速通道申请的总体目标是开发一种治疗糖尿病性胃轻瘫的药物，可以每天随餐多次有效使用，以避免胃内容物排空缓慢引起的不适。由于这种药物针对的是一种症状，而不是潜在的疾病本身，因此药物在成功治疗所需的整个慢性给药过程中保持疗效是很重要的。本研究I期临床候选人将进入II期人体临床试验。申请二期部分的总体目标是在狗胃排空模型中重复给药后证明体内疗效，并执行完成向食品和药物管理局提供良好支持的研究性新药申请（IND）所需的所有研究。

DESCRIPTION (provided by applicant): 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.