Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo. - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: GSK716155 Drug: Placebo	Phase I

MedlinePlus related topics:

Nuclear Scans

Drug Information available for:

Glucagon-like peptide 1 Glucagon

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Parallel Assignment, Pharmacodynamics Study

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Estimated Enrollment:	34
Study Start Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537719

Locations


United States, Kentucky
	GSK Investigational Site
	Lexington, Kentucky, United States, 40503

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	GLP107030
First Received:	September 28, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00537719
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

healthy,

glucagon-like peptide 1,

pharmacokinetics,

pharmacodynamics,

scintigraphy,

radiation

Study placed in the following topic categories:

Glucagon

Healthy

Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00537719