Back to resultsA Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
placebo
GSK376501
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes Mellitus focused on measuring GSK376501,, First Time in Human,, Single Dose,, Dose Escalation,, Healthy Overweight/Obese Volunteer
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404963
Brief Title
A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
Official Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
GSK376501,, First Time in Human,, Single Dose,, Dose Escalation,, Healthy Overweight/Obese Volunteer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
GSK376501
Other Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD, MPH
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
12. IPD Sharing Statement
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A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
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