HealthyEarly Phase 1NCT02335515
The Gastric Residence Time (GRT) of Soctec Capsule After a Standardized Breakfast
A Early Phase 1 study testing Soctec in people with Healthy, run by SkyePharma AG.
Trial summary
The primary objective of the study was to assess the gastric residence time (GRT) of the Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial screening visit. Eligible subjects will undergo the study procedure. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Soctec
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Mar 2015
- Phase
- Early 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male HS, aged between 18 and 50 years.
- Subjects must be in a good health and have BMI between 19 and 25 kg/m2.
- Subjects must be able to read, understand and sign the written informed consent.
- Subjects must be willing and able to comply with study requirements.
Who cannot join
- History of gastrointestinal, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse.
- Subjects with a history of HIV, hepatitis B or hepatitis C.
- Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors and non-steroidal anti-inflammatory drugs.
- Prior abdominal surgery other than uncomplicated appendectomy or hernia repair.
- Subject with claustrophobia (fear of small spaces).
- Presence of implants, devices or metallic foreign bodies that might interact with the MRI
- Participation in another investigational study where the study drug was received within 90 days prior to the screening visit.
About this study
Official title: Gastric Retention Time of Floating Gastro-Retentive Capsules in Male Healthy Subjects After Breakfast as Measured by Magnetic Resonance Imaging (MRI)
The primary objective of the study was to assess the gastric residence time (GRT) of the Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer compared to literature values reported for a simliar sized capsule.
- Conditions
- Healthy
- Being tested
- Soctec
- Keywords
- Gastroretentive System, Gastric Retention Time (GRT), capsule, Soctec, Gastroenterology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoctecDevice
Gastroretentive Drug Delivery System
| Study group | Role | What they receive |
|---|---|---|
| Soctec / Capsule | Experimental | HS intakes one(1) Soctec Capsule after standardized breakfast Receives: Device: Soctec |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast.
Measured: MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SkyePharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Karim Bagate, PhD, Study director, SkyePharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335515
- Sponsor's protocol ID
- SKY1049#10600-1-001
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2015
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Retention Time of Floating Gastro-Retentive Capsules in Male Healthy Subjects After Breakfast as Measured by Magnetic Resonance Imaging (MRI)
- ClinicalTrials.gov ID
- NCT02335515
- Acronym / sponsor ID
- SKY1049#10600-1-001
- Conditions
- Healthy
- Keywords
- Gastroretentive System, Gastric Retention Time (GRT), capsule, Soctec, Gastroenterology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- SkyePharma AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 9 Jan 2015 (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 primary objective of the study was to assess the gastric residence time (GRT) of the Soctec capsule after a standardized breakfast. 12 healthy subjects will undergo an initial screening visit. Eligible subjects will undergo the study procedure. The hypothesis is that the GRT of the Soctect Capsule after a standardized breakfast and lunch will be longer compared to literature values reported for a simliar sized capsule.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soctec / Capsule | Experimental | Device: SoctecHS intakes one(1) Soctec Capsule after standardized breakfast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male HS, aged between 18 and 50 years.
- Subjects must be in a good health and have BMI between 19 and 25 kg/m2.
- Subjects must be able to read, understand and sign the written informed consent.
- Subjects must be willing and able to comply with study requirements.
Key exclusion criteria (7 listed)
- History of gastrointestinal, cardiorespiratory (including arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disorder, panic attacks, diabetes, drug or alcohol abuse.
- Subjects with a history of HIV, hepatitis B or hepatitis C.
- Requiring medication that might alter gut function, including anticholinergics, calcium channel blockers, beta blockers, laxatives, prokinetics, proton-pump inhibitors and non-steroidal anti-inflammatory drugs.
- Prior abdominal surgery other than uncomplicated appendectomy or hernia repair.
- Subject with claustrophobia (fear of small spaces).
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 |
|---|---|---|
| SoctecGastroretentive Drug Delivery System | Device | Soctec / Capsule |
Primary outcome
To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast.
Time frame: MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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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.
Karim Bagate, PhD study director
SkyePharma AG
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Soctec in people with Healthy, run by SkyePharma AG.
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 7 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: status not confirmed, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast. (time frame: MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours). 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 9 Jan 2015.