drugset / Trial / NCT01721135
A Study to Evaluate the Effect of Two Different Repeat Doses of GSK2190915 on the QTc Interval.
RandomizedCrossoverDouble-blindTreatment
Summary
This study is a randomized, placebo controlled, four way crossover, in which the the effect of GSK2190915 on the QTc interval is assessed. Healthy subjects will recieve a 5 day course of each of the following; oral placebo, GSK2190915 100mg, GSK2190915 1000mg and moxifloxacin 400mg (single dose) with a weeks washout prior to starting the next course. Key assessments include a 12- lead electrocardiogram and pharmacokinetic testing. Safety will be assessed by blood pressure, heart rate, clinical laboratory safety tests and collection of adverse events .
Timeline
- Start
- 2010-09
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FIBOFLAPON | Small molecule | 100 mg | Oral |
| Subject | FIBOFLAPON | Small molecule | 200 mg | Oral |
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |