NCT05749068已完成不适用
An Open-label Study to Evaluate the Use of the CapScan Intestinal Collection Device to Measure the Regional Metabolism of Sulfasalazine in the Digestive Tracts of Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Regional Collection of Metabolites and Gut Microbiota
研究概览
简要总结
Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers.
详细描述
The objective is to evaluate the effectiveness of the CapScan intestinal collection device in characterizing the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
- •Physical Status Classification System 1 or
- •For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit and agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 14 days after the final dose of sulfasalazine.
- •Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form
排除标准
- •• Known or suspected gastrointestinal obstructions, strictures or fistula
- •Known or suspected moderate to severe dysmotility, by the judgement of the principal investigator
- •Gastroparesis
- •A swallowing disorder
- •Known intolerance, reaction or hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates
- •Urinary obstruction
- •Porphyria
- •Glucose-6-phosphate dehydrogenase deficiency
- •Known or suspected infection with severe acute respiratory syndrome, HIV, hepatitis B virus or hepatitis C virus
- •Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding.
- •Use of concomitant medications, such as aspirin, antibiotics, laxatives and proton pump inhibitors that may interfere with the study in the judgement of the investigator.
- •Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the principal investigator, to interfere with the conduct of the study.
- •A clinical condition that, in the judgment of the principal investigator, could potentially pose a health risk to the subject while involved in the study
研究组 & 干预措施
Experimental
Experimental
Open label experimental arm
干预措施: CapScan intestinal sampling device (Device)
结局指标
主要结局
Regional Collection of Metabolites and Gut Microbiota
时间窗: 2 days
Regional measurement of sulfasalazine in the intestinal lumen, the metabolic breakdown products of sulfasalazine and the gut microbiota in the digestive tracts of healthy volunteers.
次要结局
未报告次要终点
研究者
研究点 (1)
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