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

SkyePharma

Status and phase

Unknown

Early Phase 1

Conditions

Healthy

Treatments

Device: Soctec

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02335515

SKY1049#10600-1-001

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.