DRUG
GSK716155
albiglutide subcutaneous injection
Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.
Status
Completed
Phase
Phase 1
Enrollment
34
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
placebo injection
Timeline
From registration to results.
First posted
Oct 1, 2007
Study start
Dec 7, 2007
Primary completion
Apr 4, 2008
Study completion
Apr 4, 2008
Results posted
Not reported
Registry updated
Aug 17, 2017
Outcomes
What the study measures.
Primary outcomes
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.
Time frame · 3 Days
Secondary outcomes
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.
Time frame · 3 Days
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
GSK Investigational Site
Lexington, Kentucky, United States
Publications
Results and literature.
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