In Vivo Predictive Dissolution 1

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.

Conditions

• Healthy

Interventions

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.

Sponsors & Collaborators

• Food and Drug Administration (FDA)

  collaborator FED

• University of Michigan

  collaborator OTHER

• University of Nottingham

  lead OTHER

Principal Investigators

• Luca Marciani, PhD · University of Nottingham

• Gordon L Amidon, PhD · University of Michigan

• Greg E Amidon, PhD · University of Michigan

• Maura Corsetti, MD · University of Nottingham

• Jeff Wright, PhD · University of Nottingham

• Paul Glover, PhD · University of Nottingham

• Geoffrey S Hebbard, PhD · Melbourne Health

• Caroline L Hoad, PhD · University of Nottingham

• Penny A Gowland, PhD · University of Nottingham

• Kerby Shedden, PhD · University of Michigan

• Joseph Dickens, PhD · University of Michigan

• Robin C Spiller, MD · University of Nottingham

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-19

Primary Completion

2018-03-01

Completion

2018-03-01

Countries

• United Kingdom

Study Locations