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

NCT00559884 | Completed Phase 1

• 1 other identifier: KGW111057
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Keywords

pharmacokinetics,; healthy male and females,; pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• Blood samples:

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

• Urine:

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

Secondary Outcomes (4)

• Adverse events:

  all visits after Day -1

• blood pressure & heart rate:

  screening,Day -1 - Day 1,follow-up visit

• ECGs:

  screening,pre-dose, Day 1

• lab tests:

  screening, Day -1 - Day 1,follow-up

Interventions

GSK189075 (Modified and immediate release formulations) DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: November 1, 2007
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

US (1)