Healthy Clinical Trial - In Vivo Predictive Dissolution 1

Status Completed

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT03191045
Study type	Observational
Source	University of Nottingham
Contact
Status	Completed
Phase
Start date	July 19, 2017
Completion date	March 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06052553` - A Study of TopSpin360 Training Device	N/A
Completed	`NCT05511077` - Biomarkers of Oat Product Intake: The BiOAT Marker Study	N/A
Recruiting	`NCT04632485` - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed	`NCT05931237` - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults	N/A
Terminated	`NCT04556032` - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women	N/A
Completed	`NCT04527718` - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers	Phase 1
Completed	`NCT04065295` - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225	Phase 1
Completed	`NCT04998695` - Health Effects of Consuming Olive Pomace Oil	N/A
Completed	`NCT04107441` - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects	Phase 1
Completed	`NCT01442831` - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects	Phase 1
Terminated	`NCT05934942` - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood	Phase 1
Recruiting	`NCT05525845` - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI	N/A
Completed	`NCT05515328` - A Study in Healthy Men to Test How BI 685509 is Processed in the Body	Phase 1
Completed	`NCT04967157` - Cognitive Effects of Citicoline on Attention in Healthy Men and Women	N/A
Completed	`NCT05030857` - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects	Phase 1
Recruiting	`NCT04494269` - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls	Phase 1
Recruiting	`NCT04714294` - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers	Phase 1
Completed	`NCT04539756` - Writing Activities and Emotions	N/A
Recruiting	`NCT04098510` - Concentration of MitoQ in Human Skeletal Muscle	N/A
Completed	`NCT03308110` - Bioavailability and Food Effect Study of Two Formulations of PF-06650833	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

In Vivo Predictive Dissolution 1 — iPD1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms