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

NCT ID: NCT00559884

Last Updated: 2012-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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GSK189075 (Modified and immediate release formulations)

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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KGW111057

Identifier Type: -

Identifier Source: org_study_id

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