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

Early Phase 1

• Conditions: Healthy
• Interventions: Device: Soctec

• Registration Number: NCT02335515
• Lead Sponsor: SkyePharma AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-10
• Status Verified: 2015-01
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-08
• Last Update Submitted: 2015-01-08
• Study First Posted: 2015-01-09
• Last Update Posted: 2015-01-09
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soctec / Capsule	Soctec	HS intakes one(1) Soctec Capsule after standardized breakfast

Primary Outcome Measures

Name	Time	Method
To assess the gastric residence time (GRT) of the Soctec Capsule after a standardized breakfast.	MRI scnas will be performed every 30 minutes starting after capsule intake for up to 12 hours