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

I 期、多剂量安全性、药代动力学、药效学临床研究

• 批准号: 7375369
• 负责人: Basil Rigas
• 金额: $ 0.69万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7375369
• 关键词: PHASE; MULTIPLE; DOSE; SAFETY; PHARMACOKINETIC

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。健康的男性和女性志愿者，（2男2女）50岁及以上，有结肠癌风险，即有组织学证实的散发性结肠腺瘤或结肠癌病史的个体。 这是一项开放标签的初步药代动力学研究，其中4名受试者将接受单次剂量的NCX 4016，其将以800 mg小袋中的粉末形式提供。 访视将包括筛选访视，包括体格检查、常规实验室检查和血清妊娠（如适用）。在访视1时，访视可能持续长达10小时，并将包括体格检查、血液采样、尿液采集、研究药物给药，受试者将于第二天早上返回接受额外的血液样本。初步研究只有3次访视。