A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

• Registration Number: NCT00501930
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy males and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests.
• written consent given
• agreement to follow specific requirements of birth control during participation.

Exclusion Criteria

• history of drug or alcohol abuse within one year of the study screening.
• use of tobacco or nicotine-containing products with 6 months prior to the study screening.
• use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study.
• blood donation within 56 days before the start of the study
• receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Clinical laboratory tests, ECGs, adverse events	screening, Day -1 - 3 all periods, follow up

Secondary Outcome Measures

Name	Time	Method
blood plasma levels of GSK189075	Day 3
clinical lab tests	each day

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Madison, Wisconsin, United States