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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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2

Treatments

Drug: GSK189075 (Modified and immediate release formulations)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00559884
KGW111057

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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