Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.

Study Overview
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Brief Summary
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This study will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo.

Official Title
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A Single-Blind, Randomized, Placebo-Controlled Study in Healthy Men and Women to Determine the Effect of Single Subcutaneous Injections of GSK716155 on Gastric Emptying Time for Solid and Liquid Components of a Meal

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GSK716155
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men or women, between the ages of 18 and 65, and have a Body Mass Index (BMI) of between 20 and 32. If female, the subject must be not be capable of having children. Exclusion Criteria: Subjects must not use tobacco, nicotine, or illegal drugs of abuse, and must not take caffeine or alcohol for 24 hours before dosing and before each set of scintigraphy procedures. Subjects may not have HIV, hepatitis, elevated fasting blood sugar levels, high blood pressure, heart, lung, liver, gall bladder, gastrointestinal, pancreatic, or kidney disease, or untreated thyroid disease. Subjects must not have a history of alcohol abuse, must not take prescription or non-prescription drugs within 7 days of Day 1 and Day 8 of the study, and must not have previous exposure to any GLP-1 mimetic or exenatide. Prior radiation exposures must meet certain limits in order to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GSK716155<br>albiglutide subcutaneous injection | Drug: GSK716155<br>* albiglutide subcutaneous injection<br>|
| Placebo Comparator: placebo<br>placebo injection | Drug: Placebo<br>* placebo injection<br>* Other names: GSK716155;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the time to 50% gastric emptying (gastric emptying t½) of the solid and liquid components of a meal at 72 hours after dosing in healthy volunteers. |  | 3 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory correlation of % contents remaining in stomach after a meal.GSK716155 concentration before meal & at the time gastric emptying is complete. Safety and tolerability parameters each visit. |  | 3 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, pharmacodynamics, glucagon-like peptide 1, pharmacokinetics, scintigraphy, radiation, albiglutide