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

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ClinicalTrials.gov Identifier: NCT00559884
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Drug: GSK189075 (Modified and immediate release formulations) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559884


Locations
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00559884     History of Changes
Other Study ID Numbers: KGW111057
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline:
pharmacokinetics,
healthy male and females,
pharmacodynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases