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

Healthy Clinical Trial

Official title:

Gastric Retention Time of Floating Gastro-Retentive Capsules in Male Healthy Subjects After Breakfast as Measured by Magnetic Resonance Imaging (MRI)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02335515
• Other study ID #: SKY1049#10600-1-001
• Status: Active, not recruiting
• Phase: Phase 0
• First received: January 7, 2015
• Last updated: January 8, 2015
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2015
• Source: SkyePharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland:Kantonale Ethikkommission Zürich
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Soctec
Gastroretentive Drug Delivery System

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SkyePharma AG	University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No