Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01224587

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix placebo tablets in healthy male volunteers under fasting and fed conditions. The method which is used is an imaging technique.

Condition or Disease	Intervention/Treatment	Phase
Magnetic Marker Monitoring Gastrointestinal-transport Gastric Emptying Time Small Intestinal Transit Time Time for Colon Arrival Food Effect	Drug: D1000078 Drug: D1000082 Drug: D1000083 Drug: D1000085	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Characterisation of Gastrointestinal Transit of Four New Developed Gel Matrix Tablets With Different Erosion Rates by Means of MMM Measurement Under Fasting and Fed Conditions

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition	Drug: D1000078 Oral, one single dose
Experimental: 2 D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition	Drug: D1000082 Oral, one single dose
Experimental: 3 D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition	Drug: D1000083 Oral, one single dose
Experimental: 4 D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition	Drug: D1000085 Oral, one single dose
Experimental: 5 D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition	Drug: D1000083 Oral, one single dose
Experimental: 6 D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition	Drug: D1000085 Oral, one single dose

Outcome Measures

Primary Outcome Measures

The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET) []
The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Ethnic origin: Caucasian
Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
Good health
Written informed consent, after having been informed about benefits and potential risks of the trial

Exclusion Criteria:

Diseases which could influence the gastric emptying and gastrointestinal transport
Diet which could influence the gastric emptying and gastrointestinal transport
Surgery in the gastrointestinal tract which may interfere with the safety and transport of test product
Ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement
Regular medical treatments which could affect the gastric emptying and gastrointestinal transport

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Berlin		Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Frank Donath, MD, Socra Tec R&D GmbH, Clinical Pharmacology Unit
Study Chair: Maria Anschütz, Socra Tec R&D GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01224587

Other Study ID Numbers:

D1840M00017

First Posted:

Oct 20, 2010

Last Update Posted:

Nov 4, 2010

Last Verified:

Nov 1, 2010

Keywords provided by , ,

Imaging technique

gastric transport through the gut

Study Results

No Results Posted as of Nov 4, 2010