UnknownEarly Phase 1

The Gastric Residence Time (GRT) of Soctec Capsule After a Standardized Breakfast

15 participantsStarted 2014-09

Plain-language 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. 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.

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast.

Timeframe: MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours

Trial details

NCT IDNCT02335515

SponsorSkyePharma AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-10

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