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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00559884

Enrollment

Registered

2007-11-16

Start date

2007-11-30

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus

Keywords

pharmacokinetics,, healthy male and females,, pharmacodynamics

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.

Interventions

DRUGGSK189075 (Modified and immediate release formulations)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026