A Study to Compare the Effect on Heart Rhythm of 3 Days of GSK189075, Placebo, or Moxifloxacin in Healthy Adults
This study assesses for change in heart rhythm of healthy volunteers taking GSK189075 for 3 days at a normal dose and a higher than normal dose compared to placebo or to a single dose of moxifloxacin. Treatments are GSK189075 500mg daily for three days plus moxifloxacin placebo on Day 3; GSK189075 4000mg daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus moxifloxacin placebo on Day 3; placebo tablets daily for three days plus Moxifloxacin 400mg on Day 3. Volunteers are blindfolded during dosing. Each volunteer participates in all four treatment periods and will have received each dose combination at study end. Volunteers will stay at the research unit from the day before the first dose of study drug until the day after the last dose of study drug of each period. Safety measures include vital signs, laboratory tests on blood and urine, physical exams and ECGs. Volunteers wear a Holter monitor (a device that records heart rate and rhythm continuously) on days 1 and 3. Study drug levels are assessed by multiple blood draws, most of which occur on day 3.
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-Controlled, Cross-Over Trial to Investigate the Effect of GSK189075 on Cardiac Repolarization as Compared to Placebo and a Single Dose of Moxifloxacin in Healthy Adult Subjects|
- Continuous holter monitor & ECG each treatment period: [ Time Frame: Days 1 & 3 ]
- Drug plasma levels each treatment period: [ Time Frame: Days 2 & 3 ]
- Safety ECG, labs, vital signs & adverse events: [ Time Frame: each treatment period & follow-up ]
- Day 3 change from baseline in QTcB, QTci, QT, and HR.
- Blood drug levels of GSK189075 (pro-drug), GSK189074 (active entity), GSK279782 (active metabolite), GSK333081 (metabolite; may be analyzed as indicated by data from the dose escalation study) and moxifloxacin.
- 12-lead ECGs, vital signs, adverse events, and clinical laboratory tests.
|Study Start Date:||September 2007|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532610
|United States, Wisconsin|
|GSK Investigational Site|
|Madison, Wisconsin, United States, 53704|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|