PHASE II STUDY OF BXT 51072 IN PATIENTS W/ ULCERATIVE COLITIS

BXT 51072 在溃疡性结肠炎患者中的 II 期研究

• 批准号: 6264118
• 负责人: STEPHEN BRETT HANAUER
• 金额: $ 3.28万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264118
• 关键词: biomimetics; blood chemistry; clinical research; drug screening /evaluation; gastrointestinal disorder chemotherapy; glutathione peroxidase; human subject; human therapy evaluation; lead; longitudinal human study; pharmacokinetics; ulcerative colitis

This is a 6 month study evaluating the safety, pharacokinetics and efficacy of BXT-51072 in patients with mild to moderately active ulcerative colitis. The study will be conducted in two phases with the pharmacokinetic phase utilizing the resources of the GCRC. During the first week on study medication, patients will be hospitalized in the GCRC unit for days 1 and 2 and for 8 hours on day 7 when multiple blood samples will be taken to obtain information on the pharmacokinetics of BXT-51072 in patients with ulcerative colitis.

这是一项为期6个月的研究，评价BXT-51072在轻度至中度活动性溃疡性结肠炎患者中的安全性、药理学和疗效。本研究将分两个阶段进行，药代动力学阶段利用GCRC的资源。 在研究药物治疗的第一周内，患者将在GCRC病房住院治疗第1天和第2天，第7天住院8小时，采集多份血样以获得溃疡性结肠炎患者中BXT-51072的药代动力学信息。