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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: GSK716155

• Registration Number: NCT00537719
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-09-28
• Study First Posted: 2007-10-01
• Study Start: 2007-12-07
• Primary Completion: 2008-04-04
• Study Completion: 2008-04-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo injection
GSK716155	GSK716155	albiglutide subcutaneous injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Lexington, Kentucky, United States