Back to resultsA Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects
Primary Purpose
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK189075 (Modified and immediate release formulations)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring pharmacokinetics,, healthy male and females,, pharmacodynamics
Eligibility Criteria
Inclusion Criteria:
- Are a healthy, non-smoking adult, 18 to 55 years old.
- Are not overly thin or overly heavy for your height.
- Are a female who is unable to have children, or is willing to use birth control throughout the study.
- Are willing and able to follow all study-related instructions provided by the site staff. - Are willing to provide signed consent.
Exclusion Criteria:
- Are a pregnant or a nursing female.
- Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
- Have had certain infections within 4 weeks before the expected the first dose of study drug.
- Have HIV or hepatitis, or have alcohol in your system at the screening visit.
- Have a history of alcohol abuse.
- Have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken.
- Have laboratory tests that are outside the normal range.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Blood samples:
Urine:
Secondary Outcome Measures
Adverse events:
blood pressure & heart rate:
ECGs:
lab tests:
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00559884
Brief Title
A Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects
Official Title
An Open-label, Randomized, Single Dose, Crossover Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Modified Release Formulations of GSK189075 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to look at concentrations of GSK189075 in blood when different long and short acting forms of the drug are taken by mouth. The results will help to decide whether a long-acting form of GSK189075 can be made. The effects of the drug on the body and safety will also be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
Keywords
pharmacokinetics,, healthy male and females,, pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK189075 (Modified and immediate release formulations)
Primary Outcome Measure Information:
Title
Blood samples:
Time Frame
collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood
Title
Urine:
Time Frame
collected over 24-hour period after dosing with each form to measure amount of urine produced & amount of sugar in urine
Secondary Outcome Measure Information:
Title
Adverse events:
Time Frame
all visits after Day -1
Title
blood pressure & heart rate:
Time Frame
screening,Day -1 - Day 1,follow-up visit
Title
ECGs:
Time Frame
screening,pre-dose, Day 1
Title
lab tests:
Time Frame
screening, Day -1 - Day 1,follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Are a healthy, non-smoking adult, 18 to 55 years old.
Are not overly thin or overly heavy for your height.
Are a female who is unable to have children, or is willing to use birth control throughout the study.
Are willing and able to follow all study-related instructions provided by the site staff. - Are willing to provide signed consent.
Exclusion Criteria:
Are a pregnant or a nursing female.
Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
Have had certain infections within 4 weeks before the expected the first dose of study drug.
Have HIV or hepatitis, or have alcohol in your system at the screening visit.
Have a history of alcohol abuse.
Have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken.
Have laboratory tests that are outside the normal range.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects
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