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

AstraZeneca

Status and phase: Completed; Phase 1

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

Treatments: Drug: D1000085; Drug: D1000078; Drug: D1000083; Drug: D1000082

Study type: Interventional

Funder types: Industry

Identifiers

NCT01224587

D1840M00017

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

5 participants in 6 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: D1000078

2

Experimental group

Description:

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

Treatment:

Drug: D1000082

3

Experimental group

Description:

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

Treatment:

Drug: D1000083

4

Experimental group

Description:

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

Treatment:

Drug: D1000085

5

Experimental group

Description:

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

Treatment:

Drug: D1000083

6

Experimental group

Description:

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

Treatment:

Drug: D1000085