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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559884
• Other study ID #: KGW111057
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2007
• Last updated: May 31, 2012
• Start date: November 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• GSK189075 (Modified and immediate release formulations)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood samples:		collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood
Primary	Urine:		collected over 24-hour period after dosing with each form to measure amount of urine produced & amount of sugar in urine
Secondary	Adverse events:		all visits after Day -1
Secondary	blood pressure & heart rate:		screening,Day -1 - Day 1,follow-up visit
Secondary	ECGs:		screening,pre-dose, Day 1
Secondary	lab tests:		screening, Day -1 - Day 1,follow-up