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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224587
First Posted: October 20, 2010
Last Update Posted: November 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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 Intervention 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 Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

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)

Enrollment: 5
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224587


Locations
Germany
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
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01224587     History of Changes
Other Study ID Numbers: D1840M00017
First Submitted: October 12, 2010
First Posted: October 20, 2010
Last Update Posted: November 4, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Imaging technique
gastric transport through the gut