Magnetic Marker MonitoringPhase 1MMMNCT01224587
Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions
A Phase 1 study testing D1000078, D1000082 and D1000083 in people with Magnetic Marker Monitoring and Gastrointestinal-transport, run by AstraZeneca at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Magnetic Marker Monitoring, Gastrointestinal-transport, Gastric Emptying Time
- What is being tested?
- D1000078, D1000082 and D1000083
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- D1000078, D1000082, D1000083, D1000085
- Keywords
- Imaging technique, gastric transport through the gut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D1000078Drug
Oral, one single dose
D1000082Drug
Oral, one single dose
D1000083Drug
Oral, one single dose
D1000085Drug
Oral, one single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition Receives: Drug: D1000078 |
| 2 | Experimental | D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition Receives: Drug: D1000082 |
| 3 | Experimental | D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition Receives: Drug: D1000083 |
| 4 | Experimental | D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition Receives: Drug: D1000085 |
| 5 | Experimental | D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition Receives: Drug: D1000083 |
| 6 | Experimental | D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition Receives: Drug: D1000085 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Marker MonitoringStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Donath, MD, Principal investigator, Socra Tec R&D GmbH, Clinical Pharmacology UnitMaria Anschütz, Study chair, Socra Tec R&D GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224587
- Sponsor's protocol ID
- D1840M00017
- Acronym
- MMM
- Status last verified
- Nov 2010
- First submitted
- 12 Oct 2010
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01224587
- Acronym / sponsor ID
- MMM / D1840M00017
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: D1000078D1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition |
| 2 | Experimental | Drug: D1000082D1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition |
| 3 | Experimental | Drug: D1000083D1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition |
| 4 | Experimental | Drug: D1000085D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition |
| 5 | Experimental | Drug: D1000083D100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition |
| 6 | Experimental | Drug: D1000085D1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D1000078Oral, one single dose | Drug | 1 |
| D1000082Oral, one single dose | Drug | 2 |
| D1000083Oral, one single dose | Drug | 3, 5 |
| D1000085Oral, one single dose | Drug | 4, 6 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Donath, MD principal investigator
Socra Tec R&D GmbH, Clinical Pharmacology Unit
Maria Anschütz study chair
Socra Tec R&D GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D1000078, D1000082 and D1000083 in people with Magnetic Marker Monitoring and Gastrointestinal-transport, run by AstraZeneca at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010.