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OpenTrials
Completed

NCT Number: NCT00559884

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Columbus, Ohio, 43212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK189075 (Modified and immediate release formulations)

Drug

Primary outcomes

  1. Blood samples:

    Time frame: collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood

  2. Urine:

    Time frame: collected over 24-hour period after dosing with each form to measure amount of urine produced & amount of sugar in urine

Secondary outcomes

  1. Adverse events:

    Time frame: all visits after Day -1

  2. blood pressure & heart rate:

    Time frame: screening,Day -1 - Day 1,follow-up visit

  3. ECGs:

    Time frame: screening,pre-dose, Day 1

  4. lab tests:

    Time frame: screening, Day -1 - Day 1,follow-up

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2007
First posted
Nov 16, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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