An Open Label Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in resting anal pressure
研究概览
简要总结
This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be participating in this study. This study is composed of 2 parts:
Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an elected dose. A screening will be used to determine patients' suitability for inclusion in the trial. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose escalation. During this part, patients will undergo rectal manometry to determine anal pressure at baseline. Afterwards coated suppositories at various drug concentrations will be inserted and follow up manometries will be performed to determine response.
Patients that presented with an increase in rectal resting pressure without adverse events will enter the second part of the study. In this part, patients will be administered with a coated suppository, at a dose found at part 1 of the study to cause significant anal contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and 5 hours after insertion.
Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent.
- •Male or female subjects 18 to 55 years of age;
排除标准
- •Known allergy to the active drug or excipients.
- •Pregnancy or lactation.
- •Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
- •Type 1 diabetes mellitus;
- •Insulin treated type 2 diabetes mellitus;
- •Renal insufficiency.
- •Liver insufficiency.
- •Malignant disease within 5 years of screening;
- •History of rectal surgery.
- •History of HIV, hepatitis B, hepatitis C.
- •Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
- •Chronic use of medications with the exception of birth control pills.
研究组 & 干预措施
treatment
干预措施: coated suppository (Drug)
结局指标
主要结局
Change in resting anal pressure
时间窗: 1 day
The primary outcome is the change in resting anal pressure as measured 90 minutes after insertion of coated suppository and in comparison to baseline measurement taken before intervention.
次要结局
- Drug absorption(1 day)