- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01792453
240 mL Water Drink Study
MRI Quantification of Gastric and Small Bowel Liquid Volumes Before and After Ingestion of the Standard Oral Solid Delivery 240 mL Water Drink
Studieöversikt
Detaljerad beskrivning
Solid oral delivery is the most frequently used route of administration for pharmaceutical drug products. Along with other important physiological parameters, the volume of liquid in the small intestine (SILV) has the potential to greatly influence the rate and extent of drug dissolution and absorption in the GI tract, or "oral bioperformance". Modeled small bowel absorption of a drug can vary by more than five-fold as SILV decreases from 500 to 50 ml. To obtain reasonable predictions of oral bioperformance scientists must design meaningful in vitro dissolution tests and mechanistic drug transport models that capture the range of SILV in humans. However, little is known about liquid volumes in the gut, mostly due to invasiveness of previous techniques. A recent study has drawn great attention to the possibility of the liquid in the small intestine existing in discrete liquid "pockets" hence it would also be desirable to monitor the time courses and volumes of individual water pockets in the small intestine.
Magnetic resonance imaging (MRI) is the ideal tool to carry out serial and non-invasive imaging of gastrointestinal function. MRI is inherently suited to image liquid materials and this ability has been exploited to image liquids in the undisturbed gastrointestinal tract. Gastric emptying measurements have been long established and validated. Small bowel liquid volumes measurements have been recently validated against naso-duodenal infusion. Ultimately, the findings with this study will provide novel insights on the volume and distribution of ingested liquids in the gastrointestinal tract.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Nottingham, Storbritannien, NG7 2RD
- University of Nottingham
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Apparently healthy; no medical conditions that might affect the study measurements
- Male or female
- Age between 18 and 55 years of age
- Body mass index (BMI) between 18.5 and 24.9 kg m-2
- Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire
Exclusion Criteria:
- Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
- Known gastrointestinal disease
- Smoking
- History of alcohol or drug abuse
- Taking medication that is likely to affect gastrointestinal function
- Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am)
- Strenuous exercise greater than 10 hours per week
- Consumption of more than 21 units of alcohol in a typical week
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 240 mL water drink
Volunteers will be asked to drink 240 mL water drink
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time course of small bowel liquid volume after ingesting 240 mL of water
Tidsram: 0 - 120 mins
|
Time course for the volume of freely mobile water in the small bowel over 2 hours
|
0 - 120 mins
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time course of gastric liquid volume after ingesting 240 mL of water
Tidsram: 0 - 120 mins
|
Gastric volumes obtained from MRI as a function of time
|
0 - 120 mins
|
Number of liquid pockets in the small bowel
Tidsram: 0 - 120 mins
|
Assessment of the number of pockets of liquid in the small bowel as seen on the MR images
|
0 - 120 mins
|
Volume of liquid pockets in the small bowel
Tidsram: 0 - 120 mins
|
The volume of freely mobile liquid in each of the liquid pockets identified on the MR image
|
0 - 120 mins
|
Summary information on the location of liquid pockets by quadrant
Tidsram: 0 - 120 mins
|
Details on the distribution of the liquid pockets as seen on the MR images
|
0 - 120 mins
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kathryn Murray, PhD, University of Nottingham
- Huvudutredare: Caroline Hoad, PhD, University of Nottingham
- Huvudutredare: Penny Gowland, PhD, University of Nottingham
- Huvudutredare: Susan Pritchard, MSc, University of Nottingham
- Huvudutredare: Martin Garnett, University of Nottingham
- Huvudutredare: Robin Spiller, FRCP, University of Nottingham
- Huvudutredare: Gregory Amidon, University of Michigan
- Huvudutredare: Gordon Amidon, University of Michigan
- Huvudutredare: Deanna Mudie, University of Michigan
- Studierektor: Luca Marciani, PhD, University of Nottingham
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- A10012013
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