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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

• Registration Number: NCT00559884
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-16
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Columbus, Ohio, United States