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

Phase 1

Completed

• Conditions: Time for Colon Arrival; Gastrointestinal-transport; Small Intestinal Transit Time; Food Effect; Magnetic Marker Monitoring; Gastric Emptying Time
• Interventions: Drug: D1000085; Drug: D1000082; Drug: D1000083; Drug: D1000078

• Registration Number: NCT01224587
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Status Verified: 2010-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-11-03
• Last Update Posted: 2010-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	D1000085	D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition
2	D1000082	D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition
3	D1000083	D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition
6	D1000085	D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition
1	D1000078	D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition
5	D1000083	D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany