PHASE 1 DOSE SAFETY, PHARMACOKENETIC AND PHARMACODYNAMIC CLINICAL STUDY

点击翻译按钮获取中文摘要

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.