- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00537719
Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.
August 15, 2017 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40503
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
placebo injection
|
placebo injection
Other Names:
|
Active Comparator: GSK716155
albiglutide subcutaneous injection
|
albiglutide subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 3 Days
|
3 Days
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: 3 Days
|
3 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2007
Primary Completion (Actual)
April 4, 2008
Study Completion (Actual)
April 4, 2008
Study Registration Dates
First Submitted
September 28, 2007
First Submitted That Met QC Criteria
September 28, 2007
First Posted (Estimate)
October 1, 2007
Study Record Updates
Last Update Posted (Actual)
August 17, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GLP107030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
-
Individual Participant Data Set
Information identifier: GLP107030Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: GLP107030Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: GLP107030Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: GLP107030Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: GLP107030Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: GLP107030Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: GLP107030Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaNot yet recruiting
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States