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
Abstract
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.
Conditions: Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2.
Primary outcome: Continuous holter monitor & ECG each treatment period:.
Enrollment: 78 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 78 participants or records.
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