PHASE 1 DOSE SAFETY, PHARMACOKENETIC AND PHARMACODYNAMIC CLINICAL STUDY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是评估一种新形式的实验性阿司匹林，称为一氧化氮释放阿司匹林（NCX 4016）是否会影响大肠中某些公认的变化或异常凹陷或凹陷。这些凹陷或凹陷被认为是结肠癌的早期前兆。如果这种新的阿司匹林减少了这些凹陷或凹陷的数量和/或特征，这种化合物可能有助于预防结肠癌。还将在较小的受试者组（随机分配22名受试者，共入组16名受试者）中进行一项研究，以检测身体如何吸收、分布和排泄研究药物。这种药物没有得到美国食品和药物管理局（FDA）的批准，因此被认为是实验性的。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to evaluate whether a new form of experimental aspirin called nitric oxide releasing aspirin (NCX 4016) affects some recognized changes or abnormal pits or depressions in the large bowel. These pits or depressions are thought to be very early precursors of colon cancer. If this new aspirin reduces the number and/or the features of these pits or depressions, this compound may be useful in preventing colon cancer. In a smaller group of subjects (randomizing 22 to enroll 16 in total) a study will also be performed to test how the body absorbs, distributes and excretes the study drug. This drug is not approved by the Food and Drug Administration (FDA) and is therefore considered experimental.