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In Vivo Predictive Dissolution 1 (iPD1)

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ClinicalTrials.gov Identifier: NCT03191045
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
University of Michigan
Information provided by (Responsible Party):
Luca Marciani, University of Nottingham

Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Diagnostic Test: MRI and concomitant perfused manometry of bowel motility

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of MRI Protocols to Assess Gastrointestinal Motility With Concomitant Perfused Manometry Validation in Healthy Volunteers
Actual Study Start Date : July 19, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Group/Cohort Intervention/treatment
Healthy participants
A group of 21 healthy adult participants studied twice (test-retest)
Diagnostic Test: MRI and concomitant perfused manometry of bowel motility
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.




Primary Outcome Measures :
  1. Stomach MRI motility [ Time Frame: Over set time bins and recorded for up to 4 hours ]
    Area under the curve (AUC) of the stomach motility contractions (in mm×second) measured by MRI.


Secondary Outcome Measures :
  1. Stomach perfused manometry motility [ Time Frame: Over set time bins and recorded for up to 4 hours ]
    Area under the curve (AUC) of the stomach motility contractions (in mmHg×second) measured by perfused manometry


Other Outcome Measures:
  1. Stomach MRI and perfused manometry correlation [ Time Frame: Over set time bins and recorded for up to 4 hours ]
    Correlation between the area under the curves (AUCs) of the MRI and perfused manometry stomach motility contractions

  2. Small bowel MRI motility [ Time Frame: Over set time bins and recorded for up to 4 hours ]
    Small bowel motility by MRI (both in arbitrary units and, where possible, using actual diameter readings as above in mm×second)

  3. Small bowel perfused manometry motility [ Time Frame: Over set time bins and recorded for up to 4 hours ]
    Small bowel motility by perfused manometry (as above, in mmHg×second)

  4. Small bowel MRI and perfused manometry correlation [ Time Frame: Over set time bins and recorded for up to 4 hours ]
    Correlation between the area under the curves (AUCs) of the MRI and perfused manometry small bowel motility contractions

  5. Bowel liquid volumes [ Time Frame: Recorded for up to 4 hours ]
    Gastric, small bowel water and colonic freely mobile liquid volumes (in mL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Self-reporting, healthy adult participants, with no restrictions on gender, ethnicity or race, recruited by advertisement by poster and flyer
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191045


Locations
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United Kingdom
Nottingham Digestive Diseases Centre
Nottingham, United Kingdom, Ng7 2UH
Sponsors and Collaborators
University of Nottingham
Food and Drug Administration (FDA)
University of Michigan
Investigators
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Principal Investigator: Luca Marciani, PhD University of Nottingham
Principal Investigator: Gordon L Amidon, PhD University of Michigan
Principal Investigator: Greg E Amidon, PhD University of Michigan
Principal Investigator: Maura Corsetti, MD University of Nottingham
Principal Investigator: Jeff Wright, PhD University of Nottingham
Principal Investigator: Paul Glover, PhD University of Nottingham
Principal Investigator: Geoffrey S Hebbard, PhD Melbourne Health
Principal Investigator: Caroline L Hoad, PhD University of Nottingham
Principal Investigator: Penny A Gowland, PhD University of Nottingham
Principal Investigator: Kerby Shedden, PhD University of Michigan
Principal Investigator: Joseph Dickens, PhD University of Michigan
Principal Investigator: Robin C Spiller, MD University of Nottingham

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Responsible Party: Luca Marciani, Associate Professor, University of Nottingham
ClinicalTrials.gov Identifier: NCT03191045     History of Changes
Other Study ID Numbers: A14112016 MRI FDA
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luca Marciani, University of Nottingham:
MRI
motility
perfused manometry
stomach
bowel
water