PHASE I, MULTIPLE-DOSE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC CLINICAL STUDY

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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. Healthy male and female volunteers, (2 male 2 females) 50 years old and older at risk for colon cancer, i.e individuals with a history of histologically proven sporadic colon adenomas or colon cancer. This is an open label pilot pharmacokinetic study in which 4 subjects will receive a single dose of NCX 4016, which will be provided as powder in sachet of 800 mg. Visits will include a screening visit, which will consist of a physical exam, routine laboratories, and serum pregnancy if applicable. At Visit 1, visit may last up to 10 hours, and will include physical exam, blood sampling, urine collection, study drug administration, subject will return the following morning for additional blood samples. Pilot study is only 3 visits.