A Study to Compare the Safety and Drug Levels in Blood When Using Various Forms of GSK189075 Given to Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GSK189075 (Modified and immediate release formulations)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK189075 (Modified and immediate release formulations)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples: |  | collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood | 
| Urine: |  | collected over 24-hour period after dosing with each form to measure amount of urine produced & amount of sugar in urine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events: |  | all visits after Day -1 | 
| blood pressure & heart rate: |  | screening,Day -1 - Day 1,follow-up visit | 
| ECGs: |  | screening,pre-dose, Day 1 | 
| lab tests: |  | screening, Day -1 - Day 1,follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics,, healthy male and females,, pharmacodynamics