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.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00559884

First received: November 14, 2007

Last updated: May 31, 2012

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 14, 2007

Last Updated Date

May 31, 2012

Start Date ^ICMJE

November 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00559884 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: GSK189075 (Modified and immediate release formulations)

Other Name: GSK189075 (Modified and immediate release formulations)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00559884

Other Study ID Numbers ^ICMJE

KGW111057

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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