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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537719
• Other study ID #: GLP107030
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2007
• Last updated: August 15, 2017
• Start date: December 7, 2007
• Est. completion date: April 4, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 4, 2008
• Est. primary completion date: April 4, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GSK716155
albiglutide subcutaneous injection
• Placebo
placebo injection

Locations

Country	Name	City	State
United States	GSK Investigational Site	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study GLP107030 can be found on the GSK Clinical Study Register.