HealthyiPD1NCT03191045
In Vivo Predictive Dissolution 1
An observational study of Healthy, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MRI and concomitant perfused manometry of bowel motility
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jul 2017to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Self-reporting, healthy adult participants, with no restrictions on gender, ethnicity or race, recruited by advertisement by poster and flyer
Who may be able to join
- Aged 18-60
- Healthy
- Male or female
- Able to give informed written consent and willing to comply with required study procedures
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Diseases Centre
Nottingham, Ng7 2UH
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- MRI and concomitant perfused manometry of bowel motility
- Keywords
- MRI, motility, perfused manometry, stomach, bowel, water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and concomitant perfused manometry of bowel motilityDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | A group of 21 healthy adult participants studied twice (test-retest) Receives: Diagnostic Test: MRI and concomitant perfused manometry of bowel motility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stomach MRI motility
Area under the curve (AUC) of the stomach motility contractions (in mm×second) measured by MRI.
Measured: Over set time bins and recorded for up to 4 hours
Secondary outcomes (1)
Stomach perfused manometry motility
Area under the curve (AUC) of the stomach motility contractions (in mmHg×second) measured by perfused manometry
Measured: Over set time bins and recorded for up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start19 Jul 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), University of Michigan
- Responsible party
- Principal investigator, Luca Marciani, University of Nottingham
- Investigators
- Luca Marciani, PhD, Principal investigator, University of NottinghamGordon L Amidon, PhD, Principal investigator, University of MichiganGreg E Amidon, PhD, Principal investigator, University of MichiganMaura Corsetti, MD, Principal investigator, University of NottinghamJeff Wright, PhD, Principal investigator, University of NottinghamPaul Glover, PhD, Principal investigator, University of NottinghamGeoffrey S Hebbard, PhD, Principal investigator, Melbourne HealthCaroline L Hoad, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191045
- Sponsor's protocol ID
- A14112016 MRI FDA
- Acronym
- iPD1
- Status last verified
- Jan 2019
- First submitted
- 15 Jun 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heissam K, Abrehart N, Hoad CL, Wright J, Menys A, Murray K, Glover PM, Hebbard G, Gowland PA, Baker J, Hasler WL, Spiller RC, Corsetti M, Brasseur JG, Hens B, Shedden K, Dickens J, Mudie DM, Amidon GE, Amidon GL, Marciani L. Measurement of fasted state gastric antral motility before and after a standard bioavailability and bioequivalence 240 mL drink of water: Validation of MRI method against concomitant perfused manometry in healthy participants. PLoS One. 2020 Nov 11;15(11):e0241441. doi: 10.1371/journal.pone.0241441. eCollection 2020.
PubMed 33175860
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of MRI Protocols to Assess Gastrointestinal Motility With Concomitant Perfused Manometry Validation in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03191045
- Acronym / sponsor ID
- iPD1 / A14112016 MRI FDA
- Conditions
- Healthy
- Keywords
- MRI, motility, perfused manometry, stomach, bowel, water
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), University of Michigan
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Diagnostic Test: MRI and concomitant perfused manometry of bowel motilityA group of 21 healthy adult participants studied twice (test-retest) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Self-reporting, healthy adult participants, with no restrictions on gender, ethnicity or race, recruited by advertisement by poster and flyer
Key inclusion criteria (4 listed)
- Aged 18-60
- Healthy
- Male or female
- Able to give informed written consent and willing to comply with required study procedures
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI and concomitant perfused manometry of bowel motilityWe 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. | Diagnostic test | Healthy participants |
Primary outcome
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.
1 secondary outcome
Stomach perfused manometry motility
Time frame: Over set time bins and recorded for up to 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Derived from this study: PubMed 33175860Heissam K, Abrehart N, Hoad CL, Wright J, Menys A, Murray K, Glover PM, Hebbard G, Gowland PA, Baker J, Hasler WL, Spiller RC, Corsetti M, Brasseur JG, Hens B, Shedden K, Dickens J, Mudie DM, Amidon GE, Amidon GL, Marciani L. Measurement of fasted state gastric antral motility before and after a standard bioavailability and bioequivalence 240 mL drink of water: Validation of MRI method against concomitant perfused manometry in healthy participants. PLoS One. 2020 Nov 11;15(11):e0241441. doi: 10.1371/journal.pone.0241441. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Marciani, PhD principal investigator
University of Nottingham
Gordon L Amidon, PhD principal investigator
University of Michigan
Greg E Amidon, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stomach MRI motility (time frame: Over set time bins and recorded for up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03191045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2019.