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

May 31, 2012 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43212
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood samples:
Time Frame: collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood
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
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
Time Frame
Adverse events:
Time Frame: all visits after Day -1
all visits after Day -1
blood pressure & heart rate:
Time Frame: screening,Day -1 - Day 1,follow-up visit
screening,Day -1 - Day 1,follow-up visit
ECGs:
Time Frame: screening,pre-dose, Day 1
screening,pre-dose, Day 1
lab tests:
Time Frame: screening, Day -1 - Day 1,follow-up
screening, Day -1 - Day 1,follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 14, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KGW111057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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