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

NCT01224587 | Completed Phase 1

• 1 other identifier: D1840M00017
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Marker Monitoring; Gastrointestinal-transport; Gastric Emptying Time; Small Intestinal Transit Time; Time for Colon Arrival; Food Effect

Keywords

Imaging technique; gastric transport through the gut

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (6)

1

EXPERIMENTAL

D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition

Drug: D1000078

2

EXPERIMENTAL

D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition

Drug: D1000082

3

EXPERIMENTAL

D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition

Drug: D1000083

4

EXPERIMENTAL

D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition

Drug: D1000085

5

EXPERIMENTAL

D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition

Drug: D1000083

6

EXPERIMENTAL

D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition

Drug: D1000085

Interventions

D1000078 DRUG

Oral, one single dose

1

D1000082 DRUG

Oral, one single dose

2

D1000083 DRUG

Oral, one single dose

3; 5

D1000085 DRUG

Oral, one single dose

4; 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Berlin, Germany

Location

Study Officials

• Frank Donath, MD

  Socra Tec R&D GmbH, Clinical Pharmacology Unit

  PRINCIPAL INVESTIGATOR

• Maria Anschütz

  Socra Tec R&D GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 20, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 4, 2010

Record last verified: 2010-11

Locations

DE (1)