In Vivo Predictive Dissolution 1 (iPD1)
2019年1月15日 更新者:Luca Marciani、University of Nottingham
Development of MRI Protocols to Assess Gastrointestinal Motility With Concomitant Perfused Manometry Validation in Healthy Volunteers
This study will: 1. validate MRI motility method with concomitant perfused manometry method in healthy adult participants.
2. measure exploratory endpoints of interest including GI fluid volumes in 21 adult healthy volunteers studied twice.
研究概览
详细说明
The gastrointestinal (GI) environment where drug products dissolve has not been studied in detail due to limitations, especially invasiveness of existing techniques.
Hence little in vivo data on GI fluids and motility is available to improve relevance of predictive dissolution models and bench dissolution techniques.
Recent advances in magnetic resonance imaging (MRI) methods could provide novel data and insights.
On-going studies at the University of Michigan and at the University of Nottingham, using advanced, validated, quantitative MRI techniques have already shown that GI fluid (water) volumes can be measured.
The classical method for measuring GI motility is via a manometric method involving intubation, but it is possible to measure GI motility with MRI.
Based on our MRI motility pilot data and on the literature available, this study aims to test the main hypotheses that in healthy adult participants the new MRI method has the potential to replace current manometric study protocols and will allow a simultaneous measurement of gastrointestinal motility and fluid volumes in the gut during the fasted state.
This will establish a solid and unprecedented base of in vivo results upon which to base advances in oral pharmaceutical product science.
For this initial study, the study objectives are therefore: 1.
To validate the MRI motility method with concomitant perfused manometry method in healthy adult participants.
2. To measure exploratory endpoints of interest including GI fluid volumes.
Twenty one adult healthy volunteers will participate in this replicated study.
We will pass a thin perfused manometry tube via the nose into the gut of the participants and then take MRI images of abdominal areas while bowel motility is being measured via a tube manometric method to see how they compare.
We will be able also to measure the volume of fluids in the gut.
研究类型
观察性的
注册 (实际的)
20
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Nottingham、英国、Ng7 2UH
- Nottingham Digestive Diseases Centre
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
概率样本
研究人群
Self-reporting, healthy adult participants, with no restrictions on gender, ethnicity or race, recruited by advertisement by poster and flyer
描述
Inclusion Criteria:
- Aged 18-60
- Healthy
- Male or female
- Able to give informed written consent and willing to comply with required study procedures
Exclusion Criteria:
- Any history of serious, unstable medical condition, unstable/uncontrolled diabetes mellitus, and/ or major psychiatric diagnosis such as attention deficit hyperactivity disorder, obsessive compulsive disorder, panic attacks and generalized anxiety disorder.
- Any reported history of gastrointestinal disease
- Any significant respiratory disease such as asthma
- Any conditions requiring daily intake of any prescription and/or over-the-counter medications
- Any reported history of surgery that could affect gastrointestinal function (e.g. colectomy, small bowel resection)
- Reported alcohol dependence
- Abnormal screening procedures and laboratory results that are clinically significant in the opinion of the study medically qualified researcher
- Pregnancy
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Inability to lie flat
- Weight exceeding scanner limits of 120kg
- Poor understanding of English language
- Any conditions causing fidgeting
- Claustrophobia
- Participation of any medical trials for the past 3 months
- Judgement by the study medically qualified researcher that the candidate will be unable to comply with the full study protocol e.g. severe chronic obstructive pulmonary disease
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Healthy participants
A group of 21 healthy adult participants studied twice (test-retest)
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We will carry out serial cine MRI of the bowel.
At the same time we will record perfused manometry readings of the bowel in healthy adult participants.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Stomach MRI motility
大体时间:Over set time bins and recorded for up to 4 hours
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Area under the curve (AUC) of the stomach motility contractions (in mm×second) measured by MRI.
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Over set time bins and recorded for up to 4 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Stomach perfused manometry motility
大体时间:Over set time bins and recorded for up to 4 hours
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Area under the curve (AUC) of the stomach motility contractions (in mmHg×second) measured by perfused manometry
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Over set time bins and recorded for up to 4 hours
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Stomach MRI and perfused manometry correlation
大体时间:Over set time bins and recorded for up to 4 hours
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Correlation between the area under the curves (AUCs) of the MRI and perfused manometry stomach motility contractions
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Over set time bins and recorded for up to 4 hours
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Small bowel MRI motility
大体时间:Over set time bins and recorded for up to 4 hours
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Small bowel motility by MRI (both in arbitrary units and, where possible, using actual diameter readings as above in mm×second)
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Over set time bins and recorded for up to 4 hours
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Small bowel perfused manometry motility
大体时间:Over set time bins and recorded for up to 4 hours
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Small bowel motility by perfused manometry (as above, in mmHg×second)
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Over set time bins and recorded for up to 4 hours
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Small bowel MRI and perfused manometry correlation
大体时间:Over set time bins and recorded for up to 4 hours
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Correlation between the area under the curves (AUCs) of the MRI and perfused manometry small bowel motility contractions
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Over set time bins and recorded for up to 4 hours
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Bowel liquid volumes
大体时间:Recorded for up to 4 hours
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Gastric, small bowel water and colonic freely mobile liquid volumes (in mL)
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Recorded for up to 4 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Gordon L Amidon, PhD、University of Michigan
- 首席研究员:Greg E Amidon, PhD、University of Michigan
- 首席研究员:Maura Corsetti, MD、University of Nottingham
- 首席研究员:Jeff Wright, PhD、University of Nottingham
- 首席研究员:Paul Glover, PhD、University of Nottingham
- 首席研究员:Geoffrey S Hebbard, PhD、Melbourne Health
- 首席研究员:Caroline L Hoad, PhD、University of Nottingham
- 首席研究员:Penny A Gowland, PhD、University of Nottingham
- 首席研究员:Kerby Shedden, PhD、University of Michigan
- 首席研究员:Joseph Dickens, PhD、University of Michigan
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月19日
初级完成 (实际的)
2018年3月1日
研究完成 (实际的)
2018年3月1日
研究注册日期
首次提交
2017年6月15日
首先提交符合 QC 标准的
2017年6月15日
首次发布 (实际的)
2017年6月19日
研究记录更新
最后更新发布 (实际的)
2019年1月17日
上次提交的符合 QC 标准的更新
2019年1月15日
最后验证
2019年1月1日
更多信息
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