A Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects
This study has been completed.
Information provided by (Responsible Party):
First received: November 14, 2007
Last updated: May 31, 2012
Last verified: February 2011
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.
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug: GSK189075 (Modified and immediate release formulations)
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Blood samples: [ Time Frame: collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood ]
- 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 Measures:
- Adverse events: [ Time Frame: all visits after Day -1 ]
- blood pressure & heart rate: [ Time Frame: screening,Day -1 - Day 1,follow-up visit ]
- ECGs: [ Time Frame: screening,pre-dose, Day 1 ]
- lab tests: [ Time Frame: screening, Day -1 - Day 1,follow-up ]
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559884
|GSK Investigational Site
|Columbus, Ohio, United States, 43212 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 14, 2007
||May 31, 2012
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
healthy male and females,
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases