- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00404963
A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
January 18, 2017 updated by: GlaxoSmithKline
A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study With Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)
This study represents the first administration of GSK376501 in humans and the goal is to evaluate its initial safety and tolerability.
The way the human body processes GSK376501 will also be determined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study with Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)
Study Type
Interventional
Enrollment (Actual)
72
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
-
-
Indiana
-
Evansville, Indiana, United States, 47714
- 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
No
Genders Eligible for Study
All
Description
Inclusion:
- Healthy
- Non-smoking
- Overweight or obese subjects with a BMI between 27 and 35.
Exclusion:
- Women who are pregnant, lactating, or are of child-bearing potential
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety will be monitored by assessing adverse reactions,changes in laboratory values (hematology, clinical chemistry, urinalysis),changes in vital signs (oral body temperature,60 second respiratory rate, blood pressure and heart rate), and ECG changes.
Time Frame: throughout the study
|
throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers
Time Frame: throughout the study
|
throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: GSK Clinical Trials, MD, MPH, GlaxoSmithKline
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
October 1, 2006
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
November 27, 2006
First Submitted That Met QC Criteria
November 27, 2006
First Posted (Estimate)
November 29, 2006
Study Record Updates
Last Update Posted (Estimate)
January 19, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIX109177
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.
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