| Trial ID: | L3655 |
| Source ID: | NCT00532610
|
| Associated Drug: |
Gsk189075
|
| Title: |
A Study to Compare the Effect on Heart Rhythm of 3 Days of GSK189075, Placebo, or Moxifloxacin in Healthy Adults
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GSK189075
|
| Outcome Measures: |
Primary: Continuous holter monitor & ECG each treatment period:, Days 1 & 3 | Secondary: Drug plasma levels each treatment period:, Days 2 & 3|Safety ECG, labs, vital signs & adverse events:, 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.
|
| Sponsor/Collaborators: |
Sponsor: GlaxoSmithKline
|
| Gender: |
ALL
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| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
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| Start Date: |
2007-09
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| Completion Date: |
2008-02
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| Results First Posted: |
|
| Last Update Posted: |
2012-03-19
|
| Locations: |
GSK Investigational Site, Madison, Wisconsin, 53704, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00532610
|