NCT02335515

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Sep 2014

Shorter than P25 for early_phase_1 healthy

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

1 month

First QC Date

January 7, 2015

Last Update Submit

January 8, 2015

Conditions

Healthy

Keywords

Gastroretentive SystemGastric Retention Time (GRT)capsuleSoctecGastroenterology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Soctec / Capsule

EXPERIMENTAL

HS intakes one(1) Soctec Capsule after standardized breakfast

Device: Soctec

Interventions

SoctecDEVICE

Gastroretentive Drug Delivery System

Soctec / Capsule

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Karim Bagate, PhD

    SkyePharma AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

January 9, 2015

Record last verified: 2015-01